Back to resultsACTIV-2: A Study for Outpatients With COVID-19
Primary Purpose
Coronavirus, Covid19
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
bamlanivimab 7000mg
BRII-196+BRII-198
AZD7442 (IV)
AZD7442 (IM)
SNG001
Camostat
BMS-986414 + BMS-986413
SAB-185 (3,840 Units/kg)
SAB-185 (10,240 Units/kg)
CASIRIVIMAB + IMDEVIMAB
Placebo for Bamlanivimab 7000mg
Placebo for Bamlanivimab 700mg
Placebo for BRII-196+BRII-198
Placebo for SNG001
Placebo for Camostat
Placebo for SAB-185 (low dose)
Placebo for BMS-986414 + BMS-986413
Placebo for AZD7442 (IV)
Placebo for AZD7442 (IM)
Placebo for SAB-185 (high dose)
bamlanivimab 700mg
Sponsored by
About this trial
This is an interventional treatment trial for Coronavirus focused on measuring COVID-19, Coronavirus, COVID 19, Coronaviridae Infections, Coronavirus Infections, RNA Virus Infections, Virus Diseases, Nidovirales Infections, SARS-CoV-2, SARS Coronavirus, ACTIV-2, ACTIV2
Eligibility Criteria
Inclusion Criteria:
- Signed informed consent.
- Documentation of laboratory-confirmed SARS-CoV-2 infection, as determined by a molecular (nucleic acid) or antigen test from any respiratory tract specimen (e.g. oropharyngeal, nasopharyngeal (NP), or nasal swab, or saliva) collected ≤240 hours (10 days) prior to study entry. Laboratory-confirmed SARS-CoV-2 infection outside the US must be conducted at a DAIDS-approved laboratory.
Able to begin study treatment no later than 7 days from self-reported onset of COVID-19 related symptom(s) or measured fever, where the first day of symptoms is considered symptom day 0 and defined by the self-reported date of first reported sign/symptom from the following list:
- subjective fever or feeling feverish
- cough
- shortness of breath or difficulty breathing at rest or with activity
- sore throat
- body pain or muscle pain/aches
- fatigue
- headache
- chills
- nasal obstruction or congestion
- nasal discharge
- loss of taste or smell
- nausea or vomiting
- diarrhea
- temperature > 38°C (100.4°F)
One or more of the following signs/symptoms within 24 hours of participating in the study:
- subjective fever or feeling feverish
- cough
- shortness of breath or difficulty breathing at rest or with activity
- sore throat
- body pain or muscle pain/aches
- fatigue
- headache
- chills
- nasal obstruction or congestion
- nasal discharge
- loss of taste or smell
- nausea or vomiting
- diarrhea
- temperature > 38°C (100.4°F)
- Oxygen levels of ≥92% obtained at rest (adjusted as needed for altitude) by study staff within 24 hours of study entry. For a potential participant who regularly receives chronic supplementary oxygen for an underlying lung condition, their oxygen saturation should be measured while on their standard home oxygen supplementation level.
- Participant must agree not to participate in another clinical trial for the treatment of COVID-19 or SARS-CoV-2 during the study period until hospitalization or 28 days after the start of the study, whichever occurs first.
- Meet the protocol definition of being at "higher" risk of progression to hospitalization or death (BRII-196/BRII-198).
- In Phase III, meeting the protocol definition of being at "higher" risk of progression to hospitalization or death (SNG001, SAB-185, BMS 986414+BMS 986413)
- For participants of reproductive potential, negative serum or urine pregnancy test within 48 hours prior to study entry by any clinic or laboratory that has a CLIA certification or its equivalent, or by a point of care (POC)/CLIA-waived test. Note: Participants not of reproductive potential are eligible without requiring the use of a contraceptive method (BRII-196/BRII-198. AZD7442 [IV], AZD7442 [IM], SNG001, Camostat, SAB-185, BMS 986414+BMS 986413).
- Participants that engage in sexual activity that may lead to pregnancy in their partner must agree to either remain abstinent or use male contraceptives. They are strongly advised to inform their non-pregnant sexual partners of reproductive potential to use effective contraceptives for 24 weeks after investigational product is administered. Participants with pregnant partners should use condoms during vaginal intercourse through 24 weeks after investigational agent administration. Participants should refrain from sperm donation for 24 weeks after investigational agent administration (BRII-196/BRII-198, AZD7442 [IV], AZD7442 [IM], SAB-185).
- Participants that engage in sexual activity that may lead to pregnancy in their partner must agree to either remain abstinent or use male contraceptives for 30 days after investigational agent administration. They are also strongly advised to inform their non-pregnant sexual partners of reproductive potential to sue effective contraceptives for 30 days after investigational agent is administered to the participant. Participants with pregnant partners should use condoms during vaginal intercourse through 30 days after last dose of investigational agent administration. Participants should refrain from sperm donation for 30 days after investigational agent administration (SNG001).
- Participants that engage in sexual activity that may lead to pregnancy in their partner must agree to either remain abstinent or use male contraceptives. They are also strongly advised to inform their non-regnant sexual partners of reproductive potential to use effective contraceptives from study entry through 90 days after study treatment. Participants with pregnant partners should use condoms during vaginal intercourse from study entry through 90 days after the last dose of the study treatment. Participants should refrain from sperm donation from study entry through 90 days after the last dose of study treatment (Camostat).
- If participating in sexual activity that could lead to pregnancy, participants who are of reproductive potential must agree to use effective contraception for 24 weeks after investigational agent is administered. This would include oral contraceptives, implanted contraceptives, implanted contraceptives, intrauterine devices, and barrier methods.
- If participating in sexual activity that could lead to pregnancy, participants who are of reproductive potential must agree to use highly effective contraception for 24 weeks after investigational agent is administered (AZD7442 [IV], AZD7442 [IM], SAB-185).
- If participating in sexual activity that could lead to pregnancy, participants who are of reproductive potential must agree to use effective contraception for 30 days after investigational agent is administered (SNG001).
- If participating in sexual activity that could lead to pregnancy, participants who are of reproductive potential must agree to use effective contraception for 90 days after the last dose of treatment (Camostat).
- If participating in sexual activity that could lead to pregnancy, participants who are of reproductive potential must agree to use highly effective contraception for at least 48 weeks after the investigational agent is administered (BMS 986414+BMS 986413).
Exclusion Criteria:
- History of or current hospitalization for COVID-19.
- For the current SARS-CoV-2 infection, any positive SARS-CoV-2 nucleic acid or antigen tests from any respiratory tract specimen collected > 240 hours prior to study entry.
- Current need for hospitalization or immediate medical attention.
- Use of any prohibited medication listed in the protocol and/or use of systemic or inhaled steroids for the purpose of COVID-19 treatment (new or increased dose from chronic baseline) within 30 days prior to study.
- Receipt of convalescent COVID-19 plasma or other antibody-based anti-SARS-CoV-2 treatment or prophylaxis at any time prior to study entry.
- Receipt of other investigational treatments for SARS-CoV-2 any time before participating in the study (not including drugs approved and taken for other conditions/diseases or COVID-19 vaccines).
- Known allergy/sensitivity or hypersensitivity to study drug or placebo.
- Any condition requiring surgery up to 7 days before participating in the study, or that is considered life threatening up to 30 days before participating in the study.
- Currently pregnant or breastfeeding (BRII-196/BRII-198, AZD7442 [IV], AZD7442 [IM], SNG001, Camostat, SAB-185, BMS 986414+BMS 986413).
- In phase II, meeting the protocol definition of being at "higher" risk of progression to hospitalization or death (AZD7442 [IV], AZD7442 [IM], SNG001, Camostat, SAB-185, BMS 986414+BMS 986413).
- Inflammatory skin conditions that compromise the safety of intramuscular (IM) injections, or other overlying skin conditions or tattoos that would preclude the assessment of injection site reactions, per the discretion of the investigator (AZD7442 [IM]).
- Inflammatory skin conditions that compromise the safety of subcutaneous (SC) injections, or other overlying skin conditions or tattoos that would preclude the assessment of infection site reactions, per the discretion of the investigator (BMS 986414+BMS 986413).
- History of coagulopathy which, in the opinion of the investigator, would preclude IM injection, or use of oral or injectable anticoagulants (protocol provides more information on prohibited medications) (AZD7442 [IM]).
- Use of or need for chronic supplemental oxygen (SNG001).
- Known severe liver disease prior to enrollment (defined as ALT or AST > 5 times upper limit of normal or end stage liver disease with Child-Pugh Class C or Child-Pugh-Turcotte score ≥ 10) (Camostat).
- Known severe kidney disease prior to enrollment (defined as estimated glomerular filtration rate (eGFR) <30 ml/min/1.73m² or on renal-replacement therapy such as peritoneal dialysis or hemodialysis (Camostat)
Other investigational drug protocol-defined inclusion/exclusion criteria may apply.
Sites / Locations
- Pinnacle Research Group (Site 1082), 321 E. 10th Street
- North Alabama Research Center LLC (Site 1194), 721 W. Market St., Ste. B
- University of Alabama at Birmingham (Site 1005), 908 20th Street South
- Cullman Clinical Trials (Site 1140), 501 Clark St. NE.
- Jasper Summit Research, LLC. (Site 1056), 1280 Summit
- Absolute Clinical Research, LLC. (Site 1186), 7725 North 43rd Avenue, Ste. 211
- University of Arizona (Site 1043), 1501 N. Campbell Ave., Rm. 6410
- Omnibus Clinical Research (Site 1253), 3340 W. Ball Road, Ste. I
- Franco A. Felizarta MD (Site 1174), 3535 San Dimas St.
- Clearview Medical Research LLC. (Site 1251), 2714 Hidaway Ave., Ste. 103
- St. Jude Heritage Medical Group (Site 1093), 2151 N. Harbor Blvd.
- University of California San Diego (Site 1160), 9350 Campus Point Drive, Perlman Cancer Cancer
- Fadi A. Haddad, MD, Inc. (Site 1146), 8860 Center Dr., Ste. 320
- Atella Clinical Research (Site 1111), 5451 La Palma Avenue
- Loma Linda University Health (Site 1110), 11374 Mountain View, Dover Bldg, Ste. C
- University of Southern California (Site 1057), 1300 N. Mission Rd., Rm 349
- UCLA CARE Center (Site 1003), 11075 Santa Monica Blvd., Suite 100
- Science 37, Inc. (Site 1124), 12121 Bluff Creek Dr., Ste. 100
- VA Northern California Health Care System (NAVREF) (Site 1137), 10535 Hospital Way
- Central Valley Research, LLC (Site 1085), 400 E. Orangeburg Ave., Ste. 5
- Hoag Memorial Hospital Presbyterian (Site 1200), 1 Hoag Dr.
- Valley Clinical Research, Inc. (Site 1059), 18433 Roscoe Blvd., Ste 210
- University of California Irvine (Site 1083), 843 Health Sciences Road
- FOMAT Medical Research (Site 1136), 300 South A Street
- Eisenhower Medical Center (Site 1040), 39000 Bob Hope Drive
- Paradigm Research (Site 1150), 3652 Eureka Way
- Riverside Medical Clinic (Site 1232), 7117 Brockton Ave.
- University of California Davis Medical Center (Site 1097), 2315 Stockton Blvd.
- Premier Urgent Care Centers of California, Inc. (Site 1176), 284 E. Highland Ave.
- University of California San Diego (Site 1002), 220 Dickinson Street
- Zion Medical Center (Site 1063), 4647 Zion Avenue
- VA San Diego Health System (Stie 1127), 3350 La Jolla
- University of California San Francisco (Site 1009), 995 Potrero Ave., Building 80, Ward 84
- San Francisco Research Institute (Site 1210), 2435 Ocean Ave.
- Stanford University (Site 1213), 1201 Welch Road
- Millennium Clinical Trials (Site 1260), 550 Saint Charles Dr., Ste. 208
- Office of Ramesh V. Nathan, MD (Site 1073), 2220 Lynn Rd., Ste. 301
- Harbor UCLA (Site 1022), 1124 West Carson Street
- Allianz Research Institute Inc. (Site 1159), 14120 Beach Blvd., Ste. 101
- University of Colorado (Site 1007), 12401 East 17th Avenue
- UConn - Institute for Collaboration on Health (Site 1169), 2006 Hillside Rd., Unit 1248
- Whitman-Walker Health (Site 1027), 1337 R Street NW.
- Imagine Research of Palm Beach County (Site 1157), 709 S. Federal Hwy., Ste. 2
- Bradenton Research Center Inc. (Site 1109), 3924 9th Ave. W
- Synergy Healthcare (Site 1099), 300 Riverside Drive E., Ste. 1350
- Cardiology Physicians, P.A. (Site 1180), 305 Memorial Medical Pkwy., Ste. 301
- Midland Florida Clinical Research Center LLC (Site 1130), 665 Peachwood Drive
- Integrity Clinical Research (Site 1214), 3901 NW 79th Ave.
- Universal Axon Clinical Research (Site 1077), 3650 NW 82nd Ave.
- EMINAT Research (Site 1202), 2500 E. Commercial Blvd.
- Holy Cross Health (Site 1072), 4725 North Federal Highway
- North Florida / South Georgia Veterans Health System (Site 1133), 1601 SW Archer Rd.
- University of Florida (Site 1047), 1600 SW. Archer Rd.
- NW FL Clinical Research Group, LLC. (Site 1046), 400 Gulf Breeze Parkway
- Indago Research and Health Center (Site 1050), 3700 W. 12th Ave., Ste. 300
- AGA Clinical Trials (Site 1026), 900 West 49th Street
- Community Research of South Florida (Site 1197), 7100 W. 20th Ave., Ste. 403
- New Generation Medical Research (Site 1204), 7600 W. 20th Ave., Ste. 106
- Best Quality Research, Inc. (Site 1237), 2387 W. 68th St., Ste. 403
- Innovative Health Medical Center (Site 1222), 6750 Taft Street
- University of Florida Jacksonville (Site 1039), 655 West 8th Street
- Mayo Clinic Jacksonville (Site 1149), 4500 San Pablo Rd. S.
- QC Trials (Site 1117), 300 W. 41st Street, Ste. 203
- Lakes Research (Site 1037), 5801 NW 151 Street
- Savin Medical Group, LLC. (Site 1212), 5789B NW. 151st Street
- Amber Clinical Research, LLC. (Site 1206), 9000 NE. 2nd Avenue
- Gonzalez MD & Aswad MD Health Services (Site 1238), 3401 NW. 7th Street
- Clintex Research Group, Inc. (Site 1231), 590 SW. 27th Ave.
- Advance Medical Research Center (Site 1193) 330 SW. 27th Ave., Ste. 701
- University of Miami Miller School of Medicine CoVID Unit (Site 1068), 1425 NW. 10th Ave.
- Florida International Medical Research (Site 1239), 1890 S. Red Rd., Ste. 103
- D&H National Research Centers (Site 1205), 8485 Bird Road
- Allied Biomedical Research Institute (Site 1227), 7100 SW. 47th St., Ste. 220
- Miami Clinical Research (Site 1089), 2400 SW. 69th Ave.
- Research Institute of South Florida, Inc. (Site 1201), 9835 SW. 72nd Street, Ste. 201
- RM Medical Research, Inc. (Site 1230), 10346 W. Flagler St.
- Pro Live Medical Research Corp (Site 1219), 12781 SW. 42nd Street
- Miami Dade Medical Research Institute, LLC (Site 1223), 8955 SW. 87th Ct.
- Bravo Health Care Center (Site 1221), 1440 79 Street
- Orlando Immunology Center (Site 1045), 1707 North Mills Avenue
- Clintheory (Site 1203), 7350 Sandlake Commons Blvd.
- IMIC, Inc. (Site 1141), 18320 Franjo Rd
- Family Clinical Trials (Site 1236), 1601 N. Palm Ave., Ste. 102
- Physician Care Clinical Research, LLC. (Site 1242), 1617 S. Tuttle Ave., Ste. 1A
- Bassetti Medical Research, Inc. (Site 1158), 5825 US Highway 27 N.
- DBC Research (Site 1188), 7707 N. University Dr., Ste. 106
- ETNA Medical Center (Site 1225), 7401 N. University Drive
- Moore Clinical Research, Inc. (Site 1164), 4257 W. Kennedy Blvd.
- Tampa General Hospital Family Care Center Healthpark (Site 1088), 5802 N. 30th Street
- Infectious Disease Consultants of the Treasure Coast (Site 1171), 3735 11th Cir., Ste. 201
- AIDS Research and Treatment Center of the Treasure Coast (Site 1095), 981 37th Place
- Triple O Research Institute PA (Site 1121), 2580 Metrocentre Blvd., Ste. 4
- The Ponce de Leon Center (site 1015), 341 Ponce De Leon Avenue Northeast
- Rare Disease Research, LLC. (Site 1248), 1891 Howell Mill Rd.NW, Ste. B
- Agile Clinical Rsearch Trials, LLC (Site 1051), 750 Hammond Drive
- Balanced Life Health Care Solutions/SKYCRNG (Site 1191), 2033 Buford Hwy., Ste. 109
- IACT Health (Site 1035), 800 Talbotton Road
- Clintheory (Site 1254), 4300 Pleasant Hill Road
- One Health Research Clinic, Inc. (Site 1250), 5880 Live Oak Pkwy, Ste. 160
- Renew Health Clinical Research, LLC. (Site 1161), 1550 Janmar Rd.
- John A. Burns School of Medicine UH Clinics at Kakaako (Site 1177), 651 Ilalo St.
- Snake River Research, PLLC (Site 1120), 2900 Cortez Ave.
- Metro Infectious Disease Consultants (Site 1106), 901 McClintock Dr., Ste. 201
- Chicago Clinical Research Institute (Site 1132), 611 W. Roosevelt Rd.
- Northwestern University (Site 1025), 645 North Michigan Ave
- Rush University Medical Center (Site 1017), 600 Paulina St.
- University of Illinois at Chicago (Site 1147), 835 South Wood Street
- University of Chicago (Site 1064), 5841 S. Maryland Ave.
- Great Lakes Clinical Trials (Site 1049), 5149 N. Ashland Ave.
- Investigators Research Group, LLC. (Site 1170), 321 E. Northfield Dr., Ste. 100
- Roudebush VA Medical Center (Site 1217), 550 University Blvd
- University of Kansas Medical Center (Site 1042), 3901 Rainbow Boulevard
- MedPharmics (Site 1065), 3800 Houma Blvd.
- Clinical Trials of America, LLC. (Site 1245) 3201 Armand Street
- New Orleans Adolescent Trials Unit (Site 1028), 1440 Canal St., Suite 904
- Louisiana State University Health Sciences Center (Site 1153), 2000 Canal Street
- Ochsner Clinic Foundation (Site 1218), 1514 Jefferson Highway
- Baltimore VA Medical Center (Site 1258), 10 N. Greene St.
- Johns Hopkins University (Site 1006), 1830 East Monument Street
- Walter Reed Army Institute of Research (Site 1118), 503 Robert Grant Ave.
- Massachusetts General Hospital (Site 1016), 55 Fruit Street
- Beth Israel Deaconess Medical Center (Site 1166), 110 Francis Street
- Brigham and Women's Hospital - Therapeutics Clinical Research Site (Site 1023), 75 Francis Street
- University of Massachusetts Medical School (Site 1054), 55 Lake Avenue N.
- Vida Clinical Studies (Site 1244), 3815 Pelham Street
- Revive Research Institute (Site 1257), 32255 Northwestern Hwy.
- Revival Research Corporation (Site 1256), 13409 East 14 Mile Road
- Memorial Hospital at Gulfport (Site 1104), 4500 13th Street
- MedPharmics, LLC. (Site 1032), 15190 Community Rd.
- University of Missouri Health Care System (Site 1224), 1 Hospital Drive
- Hannibal Clinic (Site 1129), 100 Medical Drive
- Washington University School of Medicine (Site 1008), 620 South Taylor, Suite 200
- Bozeman Health Deaconess Hospital (Site 1115), 931 Highland Blvd, Ste. 3103
- Mercury Street Medical Group (Site 1074), 300 W. Mercury St.
- Quality Clinical Research (Site 1112), 10040 Regency Circle
- Las Vegas Medical Research (Site 1048), 8530 W. Sunset Rd.
- AXCES Research Group (Site 1152), 531 Harkle Road
- Bronx Prevention Research Center (Site 1108), 390 East 158th Street
- Lincoln Hospital (Site 1092), 249 East 149th Street
- Urban Health Plan, Inc. (Site 1243), 1065 Southern Blvd
- Jacobi Medical Center (Site 1105), 1400 Pelham Parkway South
- James J. Peters VA Medical Center (Site 1053), 130 West Kingsbridge Road
- Maimonides Medical Center (Site 1138), 4802 10th Avenue
- University at Buffalo, Emergency Medicine (Site 1172), 77 Goodell Street
- Flushing Hospital Medical Center (Site 1067), 4500 Parsons Blvd
- Jamaica Hospital Medical Center (Site 1066), 8900 Van Wyck Expressway
- Columbia Partnership for Prevention and Control of HIV/AIDS CTU (Site 1019), Columbia University Irving Medical Center, Department of Medicine - Division of Infectious Diseases, 180 Fort Washington Avenue, HP6 - Rm 604
- Cornell Clinical Trials Unit (Site 1011), NewYork-Presbyterian Hospital-Weill Cornell Medical Center, 525 East 68th Street
- Canton-Potsdam Hospital (Site 1076), 50 Leroy Street
- University of Rochester (Site 1010), 601 Elmwood Ave
- SUNY Stony Brook NICHD (Site 1094), HSC L-02, Rm. 142 C
- University of North Carolina at Chapel Hill (Site 1001), 130 Mason Farm Rd., Bioinformatics Bldg, 2nd Floor
- Carolina Clinical Research (Site 1167), 9040 Nations Ford Rd.
- Research Carolina Elite (Site 1247), 7480 Waterside Loop Road, Suite 201
- Duke University Medical Center (Site 1041), 40 Duke Medicine Circle
- Carteret Medical Group, LLC. (Site 1249), 302 Medical Park Ct.
- Wake Forest University Health Sciences (Site 1038), 1 Medical Center Boulevard
- Sanford Health (Site 1084), 801 Broadway N.
- The Christ Hospital (Site 1119), 2123 Auburn Avenue
- Case Western Reserve University (Site 1033), 2061 Cornell Road
- MetroHealth Medical Center (Site 1195), 2500 Metrohealth Dr.
- Ohio State University Medical Center (Site 1020), 480 Medical Center Drive
- Cincinnati CRS (Site 1004), University of Cincinnati, University Hospital, 200 Albert Sabin Way
- STAT Research (Site 1107), 66 Remick Blvd.
- Ascension St. John Clinical Research Institute (Site 1090), 1725 East 19th Street
- Providence Portland Medical Center (Site 1098), 4805 NE. Glisan Street
- Kaiser Permanente Center for Health Research (Site 1079), 3800 N. Interstate Ave.
- Portland VA Medical Center (Site 1131), 3710 SW US Veterans Hospital Rd.
- Oregon Health and Science University (Site 1259), 3181 SW. 10th Avenue
- Doylestown Hospital (Site 1122), 595 W. State Street
- University of Pennsylvania (Site 1031), 3400 Spruce Street
- The University of Pittsburgh (Site 1018), 3471 5th Ave.
- Veterans Affairs Pittsburgh Healthcare System (Site 1070), University Drive C.
- The Miriam Hospital Clinical Research Site (1142), 164 Summit Avenue
- Medtrial, LLC (Site 1134), 1718 Saint Julian Pl., Ste. 2
- Clinovacare Medical Clinical Research Center (Site 1211), 160 Medical Circle Suite D
- American Indian Clinical Trials Research Network (Site 1148), 717 Meade Street
- Sanford USD Medical Center (Site 1078), 1305 W. 18th St.
- Clinical Trials Center of Middle Tennessee (Site 1183), 100 Covey Drive
- Vanderbilt Therapeutics Clinical Research (Site 1013), Vanderbilt Health One Hundred Oaks, 719 Thompson Ln., Ste 47183
- Saint Hope Foundation Inc. (Site 1100), 6800 West Loop Street, Ste. 560
- South Texas Medical Research Institute, Inc./TTS Research (Site 1198), 1420 River Road
- PanAmerican Clinical Research, LLC. (Site 1069), 1416 Palm Blvd.
- Trinity Health and Wellness Center (Site 1030), 219 Sunset Avenue
- UT Southwestern HIV/ID Clinical Trials Unit (Site 1208), 1936 Amelia Court
- Doctors Hospital at Renaissance Health Institute for Research and Development (Site 1145), 5323 S. McColl Rd.
- Sealy Institute for Vaccine Sciences Clincial Trials Program (Site 1044), 400 Harborside Drive
- Rheumatology Center of Houston (Site 1252), 1200 Binz St., Ste. 1495
- Lyndon B. Johnson Hospital (Site 1014), 5656 Kelley Street
- University of Texas Health Science Center at Houston (Site 1055), 6431 Fannin Street, Ste. 2.112
- Houston Methodist Hospital (Site 1123), 6565 Fannin Street
- Dynamic Medical Research Group (Site 1081), 8314 Southwest Fwy
- Fairway Medical Clinic (Site 1156), 4910 Telephone Road
- Houston Heart and Vascular Associates (Site 1215), 1485 FM 1960 Bypass R. E., Ste. 100
- SMS Clincial Research, LLC. (Site 1060), 1210 N. Galloway Ave.
- Epic Medical Research, LLC (Site 1233), 106 Plaza Drive
- San Antonio Military Medical Center (Site 1173), 3551 Roger Brooke Dr.
- Inova Fairfax Medical Campus (Site 1029), 3300 Gallows Road
- Clinical Research Partners LLC (Site 1196), 7110 Forest Ave., Ste. 201
- EvergreenHealth (Site 1080), 12040 NE 128th Street, Ste MS-77
- University of Washington ACTU (Site 1012), Harborview Medical Center, 325 9th Ave.
- Providence Medical Research Center (Site 1075), 105 W. 8th Ave., Ste. 6050W
- Hershel Woody Williams VA Medical Center (Site 1128), 1540 Spring Valley Drive
- West VA University, Mary Babb Randolph Cancer Center (Site 1178), 1 Medical Center Drive
- Vida Clinical Studies (Site 1246), 5757 West Oklahoma Avenue
- Medical College of Wisconsin, Inc. (Site 1036), 8701 Watertown Plank Road
- Allegiance Research Specialists (Site 1162), 2645 N. Mayfair Rd., Ste. 200
- Instituto Médico Platense (Site 3011), Avenida 51 335
- Fundación Sanatorio Güemes (Site 3001), Francisco Acuña de Figueroa 1240
- Instituto Médico Río Cuarto (Site 3005), Hipólito Yrigoyen 1020
- Instituto Médico de la Fundación Estudios Clínicos (Site 3009), Italia 428
- Clínica Adventista Belgrano (Site 3007), Estomba 1710
- Instituto Ave Pulmo (Site 3006), Carlos M. Alvear 3345
- Hospital Universitario Austral (Site 3004), Av. Juan Domingo Peron, Derqui
- L2 Ip - Instituto de Pesquisas Clinicas Ltda (Site 4008), SGAS 613, Conjunto E, Lote 95, Sala 6
- Hospital Das Clinicas Da Universidade Federal de Minas Gerais (Site 4001), Avenida Alfredo Balena 190
- SOM Federal University Minas Gerais Brazil (Site 4002), Avenida Alfredo Balena 190
- Hospital Nossa Senhora da Conceicao (Site 4004), Avenida Francisco Trein 596
- Hospital Dia do Pulmão (Site 4007), Rua Engenheiro Paul Werner, 1141
- Hospital Das Clinicas da Faculdade de Medicina de Ribeirão Preto (Site 4003), Avenida Bandeirantes 3900, Campus Universitário
- Instituto de Pesquisa Clínica Evandro Chagas (Site 4005), Avenida Brasil, 4365
- Hospital E Maternidade Celso Pierro (Site 4006), Avenue John Boyd Dunlop S/n
- Medical Arts Health Research Group (Site 2003), 360-1855 Kirschner Rd.
- Centro Medico Militar (Site 9401), Finca El Palomar, Acatan, Sta. Rosita Zona 16
- CIMAB SA de CV (Site 6002), Francisco I Madero 270 Sur
- Oaxaca Site Management Organization (Site 6004), Calle Humboldt 302, Colonia Centro
- Instituto Jalisciense de Investigacion Clinica SA de CV (Site 6005), Penitenciaria Numero 20, Colonia Centro
- Centro de Investigación Farmacéutica Especializada de Occidente (Site 6006), Av. Vallarta 1670, Piso 2 PH1, Colonia Americana
- Neurociencias Estudios Clinicos S.C. (Site 6008), Boulevard Alfonso G. Calderon, 2193 int 2 A desarrollo urbano 3 rios
- Hospital Civil De Culiacan (Site 6011), Avenida Álvaro Obregón 1422
- Eme Red Hospitalaria (Site 6010), Calle 33 No. 496
- Kohler and Milstein Research (Site 6013), Avenida Colón 197, García Ginerés
- De La Salle Health Sciences Institute (Site 9504), Gov. Mangubat Avenue
- Makati Medical Center (Site 9502), No. 2 Amorsolo Street, Legaspi Village
- Asian Hospital and Medical Center (Site 9503), 2205 Civic Drive
- Puerto Rico AIDS Clinical Trials Unit (Site 1024), Proyecto ACTU Biomedical Building II
- Peermed Clinical Trial Center (Site 9215), Corner of Voortrekker and Monument Roads
- Worthwhile Clinical Trials (Site 9214), No. 1 Mowbray Avenue
- The Aurum Institute Tembisa Clinical Research Site (Site 9217), Cnr Flint Mazibuko / Rev RTJ Namane Drive
- Roodepoort Medicross (Site 9220), 54 Ontdekkers Road
- Soweto ACTG CRS (Site 9203), Chris Hani Road
- Helen Joseph Hospital (Site 9201), Perth Road
- Setshaba Research Centre (Site 9205), 2088 Block H
- Into Research (Site 9210), Totius Street
- Durban International Clinical Research Site (Site 9208), Sidmouth Avenue
- Welkom Clinical Trial Centre (Site 9211), 189 Power Road
- The Aurum Institute Klerksdorp Clinical Research Center (Site 9204), Corner Margaretha Prinsloo St. and O.R. Tambo St.
- The Aurum Institute Rustenburg Clinical Research Site (Site 9202), 50 Steen St., c/o Pretorius St.
- TASK Eden (Site 9218), G, 4 Victoria St.
- CLINRESCO, ARWYP Medical Suites (Site 9209), 22 Pine Avenue
- Mzansi Ethical Research Centre (Site 9212), 184 Cowen Ntuli Street, Steve Tschwete
- Global Clinical Trials Sunnyside (Site 9216), 175 Steve Biko Street
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Arm 11
Arm 12
Arm 13
Arm 14
Arm 15
Arm 16
Arm 17
Arm 18
Arm 19
Arm 20
Arm 21
Arm 22
Arm 23
Arm 24
Arm 25
Arm Type
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Active Comparator
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Active Comparator
Arm Label
Bamlanivimab 7000 mg (Phase 2)
Bamlanivimab 7000mg Placebo (Phase 2)
Bamlanivimab 700mg (Phase 2)
Bamlanivimab 700mg Placebo (Phase 2)
Bamlanivimab 700mg (Phase 3)
BRII-196+BRII-198 (Pooled Phase 2/3)
BRII-196+BRII-198 Placebo (Pooled Phase 2/3)
AZD7442 (IV) (Phase 2)
AZD7442 (IV) Pooled Placebo (Phase 2)
AZD7442 (IM) (Phase 2)
AZD7442 (IM) Pooled Placebo (Phase 2)
SNG001 (Phase 2)
SNG001 Pooled Placebo (Phase 2)
Camostat (Phase 2)
Camostat Pooled Placebo (Phase 2)
SAB-185 (low dose) (Phase 2)
SAB-185 (low dose) Pooled Placebo (Phase 2)
SAB-185 (low dose) (Phase 3) Non-OMICRON population
Casirivimab and Imdevimab (Phase 3) Non-OMICRON population
SAB-185 (high dose) (Phase 2)
SAB-185 (high dose) Pooled Placebo (Phase 2)
BMS 986414+BMS 986413 (Phase 2)
BMS 986414+BMS 986413 Pooled Placebo (Phase 2)
SAB-185 (low dose) (Phase 3) OMICRON population
Casirivimab and Imdevimab (Phase 3) OMICRON population
Arm Description
Administered by IV infusion.
Administered by IV infusion
Administered by IV infusion
Administered by IV infusion
Administered by IV infusion
Administered by IV infusion
Administered by IV infusion
Administered by IV infusion
Administered by IV infusion; shared placebo includes AZD7442 (IM) placebo and placebo from other comparator arms in the study.
Administered by IM injection
Administered by IM injection; shared placebo includes AZD7442 (IV) placebo and placebo from other comparator arms in the study.
Administered by inhalation
Administered by inhalation; shared placebo includes placebo from other comparator arms in the study.
Administered as oral tablets
Administered as oral tablets; shared placebo includes placebo from other comparator arms in the study.
Administered by IV infusion
Administered by IV infusion; includes SAB-185 (high dose) placebo and placebo from other comparator arms in the study.
Administered by IV infusion. The "Non-Omicron subpopulation" enrolled under Protocol Version 7 was defined as all participants enrolled under Protocol Version 7 excluding those in the "Omicron subpopulation." Omicron/Non-Omicron subpopulation definitions were updated in Version 10.0 of the Primary SAP to be based on the timing of emergence of the Omicron variant within the study population as follows: Variant information from any sample (i.e., not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations. For participants without variant information, those randomized under Protocol Version 7.0 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
Administered by IV infusion. The "Non-Omicron subpopulation" enrolled under Protocol Version 7 was defined as all participants enrolled under Protocol Version 7 excluding those in the "Omicron subpopulation." Omicron/Non-Omicron subpopulation definitions were updated in Version 10.0 of the Primary SAP to be based on the timing of emergence of the Omicron variant within the study population as follows: Variant information from any sample (i.e., not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations. For participants without variant information, those randomized under Protocol Version 7.0 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
Administered by IV infusion
Administered by IV infusion; includes SAB-185 (low dose) placebo and placebo from other comparator arms in the study.
Administered as subcutaneous (SC) injections
Administered as subcutaneous (SC) injections; shared placebo includes placebo from other comparator arms in the study.
Administered by IV infusion The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0. Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows: Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations. For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
Administered by IV infusion The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0. Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows: Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations. For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
Outcomes
Primary Outcome Measures
COVID-19 Symptom Duration (Phase 2)
Bamlanivimab arms:
Symptom duration=max. duration (days) across targeted symptoms including: feeling feverish, cough, shortness of breath/difficulty breathing at rest/with activity, sore throat, body pain/muscle pain/aches, fatigue, headache, chills, nasal obstruction/congestion, nasal discharge, nausea, vomiting, and diarrhea. Subjects who die on/before day 28 assigned symptom duration 29 days.
No scale. Min. value: 0 Days, Max. Value 29 Days. Higher value=worse health condition.
Non-Bamlanivimab arms:
13 symptoms (as for Bamlanivimab) scored daily as absent (score 0), mild (score 1), moderate (score 2) or severe (score 3). Symptom duration=time (days) from Day 0 (pre-treatment) to first of two consecutive days when all symptoms scored moderate/severe at Day 0 (pre-treatment) are scored mild/absent, AND all symptoms scored mild/absent at Day 0 (pre-treatment) are scored absent.
No scale. Min. value: 0 Days, Max. Value 26 Days. Higher value=worse health condition.
Quantification of SARS-CoV-2 RNA (Phase 2)
Bamlanivimab Agent arms:
Measured as Detected or Undetected from staff-collected NP (nasopharyngeal) swabs. Lower Limit of Detection is 1.4 (log 10 copies/ml).
Non-Bamlanivimab Agent arms:
Measured as below Lower Limit of Quantification (LLoQ) or at/above LLoQ from staff-collected NP (nasopharyngeal) swabs. Lower Limit of Quantification is 2 (log 10 copies/ml).
SNG001 and SNG001 Pooled Placebo arm each exclude 6 participants, due to unsuitable sample specimen conditions.
Quantification of SARS-CoV-2 RNA (Phase 2)
Bamlanivimab Agent arms:
Measured as Detected or Undetected from staff-collected NP (nasopharyngeal) swabs. Lower Limit of Detection is 1.4 (log 10 copies/ml).
Non-Bamlanivimab Agent arms:
Measured as below Lower Limit of Quantification (LLoQ) or at/above LLoQ from staff-collected NP (nasopharyngeal) swabs. Lower Limit of Quantification is 2 (log 10 copies/ml).
Quantification of SARS-CoV-2 RNA (Phase 2)
Bamlanivimab Agent arms:
Measured as Detected or Undetected from staff-collected NP (nasopharyngeal) swabs. Lower Limit of Detection is 1.4 (log 10 copies/ml).
Non-Bamlanivimab Agent arms:
Measured as below Lower Limit of Quantification (LLoQ) or at/above LLoQ from staff-collected NP (nasopharyngeal) swabs. Lower Limit of Quantification is 2 (log 10 copies/ml).
Proportion of Participants With New Adverse Event (AE) ≥ Grade 3 (Phase 2)
AE Severity: Adverse event Severity grading followed Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), corrected Version 2.1, July 2017, which can be found on the DAIDS RSC website at:
https://rsc.niaid.nih.gov/clinical-research-sites/daids-adverse-event-grading-tables.
Grade 1 indicates a mild event
Grade 2 indicates a moderate event
Grade 3 indicates a severe event
Grade 4 indicates a potentially life-threatening event
Grade 5 indicates death
Cumulative Incidence of Death Due to Any Cause or Hospitalization Due to Any Cause (Phase 3)
Hospitalization defined as ≥24 hours of acute care in a hospital or similar acute care facility, including Emergency Rooms or temporary facilities instituted to address medical needs of those with severe COVID-19
Proportion of Participants With New Adverse Event (AE) ≥ Grade 3 (Phase 3)
AE Severity: Adverse event Severity grading followed Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), corrected Version 2.1, July 2017, which can be found on the DAIDS RSC website at:
https://rsc.niaid.nih.gov/clinical-research-sites/daids-adverse-event-grading-tables.
Grade 1 indicates a mild event
Grade 2 indicates a moderate event
Grade 3 indicates a severe event
Grade 4 indicates a potentially life-threatening event
Grade 5 indicates death
Secondary Outcome Measures
COVID-19 Symptom Duration (Phase 3)
Duration defined as the number of days from start of investigational agent to the first of two consecutive days when any symptoms scored as moderate or severe as study entry (pre-treatment) are scored as mild or absent; and any symptoms scored as mild or absent at study entry are scored as absent, AND any symptoms scored as mile or absent at study entry (pre-treatment) are scored as absent. Targeted symptoms are: Feeling feverish; cough, shortness of breath or difficulty breathing; sore throat; body pain or muscle pain/aches; fatigue (low energy); headache, chills, nasal obstruction or congestion (stuffy nose); nasal discharge (runny nose); nausea or vomiting; and diarrhea. Each symptom is scored daily by the participant as absent (score 0), mild (1), moderate (2) or severe (3)
Quantification of SARS-CoV-2 RNA (Phase 3)
Measured as quantification (<LLoQ versus ≥LLoQ ) from staff-collected NP (nasopharyngeal) swabs
Cumulative Incidence of Death From Any Cause or Hospitalization Due to Any Cause (Phase 2)
Hospitalization defined as ≥24 hours of acute care in a hospital or similar acute care facility, including Emergency Rooms or temporary facilities instituted to address medical needs of those with severe COVID-19
Cumulative Incidence of Death From Any Cause, or Hospitalization Due to Any Cause Related to COVID-19 (Phase 3)
Hospitalizations due to any cause deemed unrelated to COVID-19 are excluded. Hospitalization defined as ≥24 hours of acute care in a hospital or similar acute care facility, including Emergency Rooms or temporary facilities instituted to address medical needs of those with severe COVID-19
Level of SARS-CoV-2 RNA From NP Swabs (Phase 2)
Measured from staff-collected NP swabs
Level of SARS-CoV-2 RNA From NP Swabs (Phase 3)
Measured from staff-collected NP swabs
Duration of Targeted Clinical COVID-19 Symptoms (Phases 2 and 3)
Duration defined as the number of days from start of investigational agent to the first of four consecutive days when all symptoms scored as absent. Targeted symptoms are: Feeling feverish; cough, shortness of breath or difficulty breathing; sore throat; body pain or muscle pain/aches; fatigue (low energy); headache, chills, nasal obstruction or congestion (stuffy nose); nasal discharge (runny nose); nausea or vomiting; and diarrhea. Each symptom is scored daily by the participant as absent (score 0), mild (1), moderate (2) or severe (3)
COVID-19 Symptom Severity Ranking (Phases 2 and 3)
Symptoms scored daily as absent (score 0), mild (score 1), moderate (score 2) or severe (score 3). Symptoms: feeling feverish, cough, shortness of breath/difficulty breathing at rest/with activity, sore throat, body pain/muscle pain/aches, fatigue, headache, chills, nasal obstruction/congestion, nasal discharge, nausea, vomiting, and diarrhea. Subjects alive and never hospitalized through Day 28: Symptom Severity Ranking=subject-specific AUC (area under curve) joining daily total symptom score associated with COVID-19 disease, over time (through Day 28, counting Day 0 as first day), calculated by trapezoidal rule and rescaled for time by dividing by the total number of trapezoids. Subjects who died within Day 28: Assigned severity score 42; Subjects alive but remaining hospitalized at Day 28: Assigned severity score 41; Subjects alive but no longer hospitalized at Day 28: Assigned severity score 40.
Calculated Severity Score=scale of 0 to 42. Higher value=worse health condition.
Proportion of Participants With ≥1 Worsening Symptom of COVID-19 (Phases 2 and 3)
Progression of one or more COVID-19-associated symptoms to a worse status than recorded in study diary at study entry, prior to start of investigational product or placebo
Time to Self-reported Return to Usual Health (a) (Phases 2 and 3)
Defined as the number of days from start of investigational treatment until the first of two consecutive days that a participant reported return to usual (pre-COVID-19) health as recorded in a participant's study diary
Cumulative Incidence of Death Due to Any Cause or Hospitalization Due to Any Cause (Phases 2 and 3)
Cumulative Incidence of Death Due to Any Cause or Hospitalization Due to Any Cause (Phases 2 and 3)
Oxygen Saturation Level (Phases 2 and 3)
Measured by pulse oximeter and categorized as <96% versus ≥96%
AUC of SARS-CoV-2 RNA From Site-collected NP Swabs (Phase 2)
Measured by area under the curve (AUC) and above assay lower limit of quantification of quantitative SARS-CoV-2 RNA over time
Incidence of New Adverse Event (AE) ≥ Grade 2 (Phases 2 and 3)
Incidence of New Adverse Event (AE) ≥ Grade 2 (Phases 2 and 3)
Incidence of New Adverse Event (AE) ≥ Grade 3 (Phases 2 and 3)
Time to Self-reported Return to Usual Health (b) (Phases 2 and 3)
Defined as the number of days from start of investigational treatment until the first of four consecutive days that a participant reported return to usual (pre-COVID-19) health as recorded in a participant's study diary
Full Information
NCT ID
NCT04518410
First Posted
August 17, 2020
Last Updated
July 6, 2023
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Eli Lilly and Company, AIDS Clinical Trials Group, Brii Biosciences Limited, AstraZeneca, Sagent Pharmaceuticals, Synairgen Research Ltd., Bristol-Myers Squibb, SAb Biotherapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04518410
Brief Title
ACTIV-2: A Study for Outpatients With COVID-19
Official Title
Adaptive Platform Treatment Trial for Outpatients With COVID-19 (Adapt Out COVID)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
August 19, 2020 (Actual)
Primary Completion Date
April 7, 2022 (Actual)
Study Completion Date
June 20, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Eli Lilly and Company, AIDS Clinical Trials Group, Brii Biosciences Limited, AstraZeneca, Sagent Pharmaceuticals, Synairgen Research Ltd., Bristol-Myers Squibb, SAb Biotherapeutics, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Drug studies often look at the effect one or two drugs have on a medical condition, and involve one company. There is currently an urgent need for one study to efficiently test multiple drugs from more than one company, in people who have tested positive for COVID-19 but who do not currently need hospitalization. This could help prevent disease progression to more serious symptoms and complications, and spread of COVID-19 in the community.
This study looks at the safety and effectiveness of different drugs in treating COVID-19 in outpatients. In Phase II, participants in the study will be treated with either a study drug or with placebo. In protocol version 7.0, participants in Phase III of the study will be treated with either a study drug or active comparator drug. Participants assigned to the bamlanivimab agent/placebo arm and will have 28 days of intensive follow-up following study drug administration, followed by limited follow-up through 24 weeks in phase II and in phase III. All other investigational agents and their corresponding placebo arms will involve 28 days of intensive follow-up, followed by limited follow-up through 72 weeks in phase II and phase III. Additional study visits may be required, depending on the agent.
Detailed Description
This is a master protocol to evaluate the safety and efficacy of multiple investigational agents aimed at modifying the host immune response to SARS-CoV-2 infection, or directly enhancing viral control in order to limit disease progression.
The study includes both infused and non-infused agents and is a randomized controlled platform that allows agents to be added and dropped during the course of the study for efficient phase II and phase III testing of new agents within the same trial infrastructure.
Version 7 of the protocol provided for blinded phase II evaluation of an investigational agent for superiority to placebo among participants at lower risk of progression to hospitalization or death, regardless of the mode of administration of the agent.
Agents that graduate to phase III after initiation of the protocol version will be evaluated in persons at higher risk for progression to hospitalization or death for non-inferiority to an active comparator (monoclonal antibody cocktail of casirivimab plus imdevimab (REGEN-COV, Regeneron). This active comparator has been shown to be effective in this population in preventing hospitalization or death. When two or more agents are being evaluated in the same phase of the study, the trial design includes sharing of the control group (placebo in phase II and active comparator in phase III) for efficient evaluation of each agent.
Investigational agents will be approved by the Trial Oversight Committee (TOC) for phase II evaluation based on the presence of in vitro data demonstrating promise as anti-SARS-CoV-2 therapeutics in pre-clinical testing, and for which there are suitable pharmacokinetics and safety data from phase I testing, or through clinical or research testing for a different indication, and agent availability. Investigational agents will be included in phase III evaluation based on agent entry criteria for phase III as outlined in the protocol (or by TOC approval based on data available outside ACTIV-2).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronavirus, Covid19
Keywords
COVID-19, Coronavirus, COVID 19, Coronaviridae Infections, Coronavirus Infections, RNA Virus Infections, Virus Diseases, Nidovirales Infections, SARS-CoV-2, SARS Coronavirus, ACTIV-2, ACTIV2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Masking Description
Unblinded data will be provided to the Data and Safety Monitoring Board for interim analyses. Unblinded Day 28 data will also be provided to a small group of people from the company who owns the investigational agent, to assist the company in deciding if the agent should move into phase 3 evaluation; or in choosing a dose of their agent to move into phase 3 evaluation.
Allocation
Randomized
Enrollment
4044 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bamlanivimab 7000 mg (Phase 2)
Arm Type
Experimental
Arm Description
Administered by IV infusion.
Arm Title
Bamlanivimab 7000mg Placebo (Phase 2)
Arm Type
Placebo Comparator
Arm Description
Administered by IV infusion
Arm Title
Bamlanivimab 700mg (Phase 2)
Arm Type
Experimental
Arm Description
Administered by IV infusion
Arm Title
Bamlanivimab 700mg Placebo (Phase 2)
Arm Type
Placebo Comparator
Arm Description
Administered by IV infusion
Arm Title
Bamlanivimab 700mg (Phase 3)
Arm Type
Experimental
Arm Description
Administered by IV infusion
Arm Title
BRII-196+BRII-198 (Pooled Phase 2/3)
Arm Type
Experimental
Arm Description
Administered by IV infusion
Arm Title
BRII-196+BRII-198 Placebo (Pooled Phase 2/3)
Arm Type
Placebo Comparator
Arm Description
Administered by IV infusion
Arm Title
AZD7442 (IV) (Phase 2)
Arm Type
Experimental
Arm Description
Administered by IV infusion
Arm Title
AZD7442 (IV) Pooled Placebo (Phase 2)
Arm Type
Placebo Comparator
Arm Description
Administered by IV infusion; shared placebo includes AZD7442 (IM) placebo and placebo from other comparator arms in the study.
Arm Title
AZD7442 (IM) (Phase 2)
Arm Type
Experimental
Arm Description
Administered by IM injection
Arm Title
AZD7442 (IM) Pooled Placebo (Phase 2)
Arm Type
Placebo Comparator
Arm Description
Administered by IM injection; shared placebo includes AZD7442 (IV) placebo and placebo from other comparator arms in the study.
Arm Title
SNG001 (Phase 2)
Arm Type
Experimental
Arm Description
Administered by inhalation
Arm Title
SNG001 Pooled Placebo (Phase 2)
Arm Type
Placebo Comparator
Arm Description
Administered by inhalation; shared placebo includes placebo from other comparator arms in the study.
Arm Title
Camostat (Phase 2)
Arm Type
Experimental
Arm Description
Administered as oral tablets
Arm Title
Camostat Pooled Placebo (Phase 2)
Arm Type
Placebo Comparator
Arm Description
Administered as oral tablets; shared placebo includes placebo from other comparator arms in the study.
Arm Title
SAB-185 (low dose) (Phase 2)
Arm Type
Experimental
Arm Description
Administered by IV infusion
Arm Title
SAB-185 (low dose) Pooled Placebo (Phase 2)
Arm Type
Placebo Comparator
Arm Description
Administered by IV infusion; includes SAB-185 (high dose) placebo and placebo from other comparator arms in the study.
Arm Title
SAB-185 (low dose) (Phase 3) Non-OMICRON population
Arm Type
Experimental
Arm Description
Administered by IV infusion.
The "Non-Omicron subpopulation" enrolled under Protocol Version 7 was defined as all participants enrolled under Protocol Version 7 excluding those in the "Omicron subpopulation."
Omicron/Non-Omicron subpopulation definitions were updated in Version 10.0 of the Primary SAP to be based on the timing of emergence of the Omicron variant within the study population as follows:
Variant information from any sample (i.e., not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
For participants without variant information, those randomized under Protocol Version 7.0 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
Arm Title
Casirivimab and Imdevimab (Phase 3) Non-OMICRON population
Arm Type
Active Comparator
Arm Description
Administered by IV infusion.
The "Non-Omicron subpopulation" enrolled under Protocol Version 7 was defined as all participants enrolled under Protocol Version 7 excluding those in the "Omicron subpopulation."
Omicron/Non-Omicron subpopulation definitions were updated in Version 10.0 of the Primary SAP to be based on the timing of emergence of the Omicron variant within the study population as follows:
Variant information from any sample (i.e., not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
For participants without variant information, those randomized under Protocol Version 7.0 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
Arm Title
SAB-185 (high dose) (Phase 2)
Arm Type
Experimental
Arm Description
Administered by IV infusion
Arm Title
SAB-185 (high dose) Pooled Placebo (Phase 2)
Arm Type
Placebo Comparator
Arm Description
Administered by IV infusion; includes SAB-185 (low dose) placebo and placebo from other comparator arms in the study.
Arm Title
BMS 986414+BMS 986413 (Phase 2)
Arm Type
Experimental
Arm Description
Administered as subcutaneous (SC) injections
Arm Title
BMS 986414+BMS 986413 Pooled Placebo (Phase 2)
Arm Type
Placebo Comparator
Arm Description
Administered as subcutaneous (SC) injections; shared placebo includes placebo from other comparator arms in the study.
Arm Title
SAB-185 (low dose) (Phase 3) OMICRON population
Arm Type
Experimental
Arm Description
Administered by IV infusion The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0.
Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows:
Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
Arm Title
Casirivimab and Imdevimab (Phase 3) OMICRON population
Arm Type
Active Comparator
Arm Description
Administered by IV infusion The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0.
Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows:
Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations.
For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.
Intervention Type
Biological
Intervention Name(s)
bamlanivimab 7000mg
Other Intervention Name(s)
LY3819253
Intervention Description
Administered by single IV infusion. Participants are no longer being randomized to this intervention.
Intervention Type
Biological
Intervention Name(s)
BRII-196+BRII-198
Intervention Description
1000 mg (BRII-196)/1000 mg (BRII-198) combination therapy. Administered by consecutive IV infusions as single dose. Participants are no longer being randomized to this intervention.
Intervention Type
Biological
Intervention Name(s)
AZD7442 (IV)
Other Intervention Name(s)
AZD8895 + AZD1061
Intervention Description
300 mg AZD7442 (150 mg AZD8895 + 150 mg AZD1061). Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
Intervention Type
Biological
Intervention Name(s)
AZD7442 (IM)
Other Intervention Name(s)
AZD8895 + AZD1061
Intervention Description
Administered intramuscularly as 2 separate injections sequentially (300 mg AZD8895 then 300 mg AZD1061) for one dose. Injections administered in the side of the thigh, one injection in each thigh. Participants are no longer being randomized to this intervention.
Intervention Type
Drug
Intervention Name(s)
SNG001
Intervention Description
1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
Intervention Type
Drug
Intervention Name(s)
Camostat
Other Intervention Name(s)
FOY-305, camostat mesilate, camostat mesylate
Intervention Description
200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
Intervention Type
Biological
Intervention Name(s)
BMS-986414 + BMS-986413
Other Intervention Name(s)
C135-LS + C144-LS
Intervention Description
Administered subcutaneously (SC) as 4 separate injections for one dose (two injections of C135-LS 200mg and two injections of C144-SL 200mg). Participants are no longer being randomized to this intervention.
Intervention Type
Biological
Intervention Name(s)
SAB-185 (3,840 Units/kg)
Other Intervention Name(s)
Anti-SARS-CoV-2 Human Immunoglobulin Intravenous (Tc bovine-derived)
Intervention Description
Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
Intervention Type
Biological
Intervention Name(s)
SAB-185 (10,240 Units/kg)
Other Intervention Name(s)
Anti-SARS-CoV-2 Human Immunoglobulin Intravenous (Tc bovine-derived)
Intervention Description
Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
Intervention Type
Drug
Intervention Name(s)
CASIRIVIMAB + IMDEVIMAB
Other Intervention Name(s)
REGN10933 + REGN10987, REGN-COV2
Intervention Description
600 mg casirivimab and 600 mg imdevimab, administered together as single IV infusion as one-time dose at study entry. Participants are no longer being randomized to this intervention.
Intervention Type
Drug
Intervention Name(s)
Placebo for Bamlanivimab 7000mg
Intervention Description
Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
Intervention Type
Drug
Intervention Name(s)
Placebo for Bamlanivimab 700mg
Intervention Description
Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
Intervention Type
Drug
Intervention Name(s)
Placebo for BRII-196+BRII-198
Intervention Description
Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
Intervention Type
Drug
Intervention Name(s)
Placebo for SNG001
Intervention Description
Trisodium citrate dihydrate, di-sodium hydrogen-phosphate, sodium dihydrogen-phosphate dihydrate, racemic methionine (DL-methionine) and water. 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
Intervention Type
Drug
Intervention Name(s)
Placebo for Camostat
Intervention Description
200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
Intervention Type
Drug
Intervention Name(s)
Placebo for SAB-185 (low dose)
Intervention Description
Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
Intervention Type
Drug
Intervention Name(s)
Placebo for BMS-986414 + BMS-986413
Intervention Description
Administered SC as 4 separate injections for one dose. Participants are no longer being randomized to this intervention.
Intervention Type
Drug
Intervention Name(s)
Placebo for AZD7442 (IV)
Intervention Description
Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
Intervention Type
Drug
Intervention Name(s)
Placebo for AZD7442 (IM)
Intervention Description
Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
Intervention Type
Drug
Intervention Name(s)
Placebo for SAB-185 (high dose)
Intervention Description
Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
Intervention Type
Biological
Intervention Name(s)
bamlanivimab 700mg
Other Intervention Name(s)
LY3819253
Intervention Description
Administered by single IV infusion. Participants are no longer being randomized to this intervention.
Primary Outcome Measure Information:
Title
COVID-19 Symptom Duration (Phase 2)
Description
Bamlanivimab arms:
Symptom duration=max. duration (days) across targeted symptoms including: feeling feverish, cough, shortness of breath/difficulty breathing at rest/with activity, sore throat, body pain/muscle pain/aches, fatigue, headache, chills, nasal obstruction/congestion, nasal discharge, nausea, vomiting, and diarrhea. Subjects who die on/before day 28 assigned symptom duration 29 days.
No scale. Min. value: 0 Days, Max. Value 29 Days. Higher value=worse health condition.
Non-Bamlanivimab arms:
13 symptoms (as for Bamlanivimab) scored daily as absent (score 0), mild (score 1), moderate (score 2) or severe (score 3). Symptom duration=time (days) from Day 0 (pre-treatment) to first of two consecutive days when all symptoms scored moderate/severe at Day 0 (pre-treatment) are scored mild/absent, AND all symptoms scored mild/absent at Day 0 (pre-treatment) are scored absent.
No scale. Min. value: 0 Days, Max. Value 26 Days. Higher value=worse health condition.
Time Frame
Up to Day 28
Title
Quantification of SARS-CoV-2 RNA (Phase 2)
Description
Bamlanivimab Agent arms:
Measured as Detected or Undetected from staff-collected NP (nasopharyngeal) swabs. Lower Limit of Detection is 1.4 (log 10 copies/ml).
Non-Bamlanivimab Agent arms:
Measured as below Lower Limit of Quantification (LLoQ) or at/above LLoQ from staff-collected NP (nasopharyngeal) swabs. Lower Limit of Quantification is 2 (log 10 copies/ml).
SNG001 and SNG001 Pooled Placebo arm each exclude 6 participants, due to unsuitable sample specimen conditions.
Time Frame
Day 3
Title
Quantification of SARS-CoV-2 RNA (Phase 2)
Description
Bamlanivimab Agent arms:
Measured as Detected or Undetected from staff-collected NP (nasopharyngeal) swabs. Lower Limit of Detection is 1.4 (log 10 copies/ml).
Non-Bamlanivimab Agent arms:
Measured as below Lower Limit of Quantification (LLoQ) or at/above LLoQ from staff-collected NP (nasopharyngeal) swabs. Lower Limit of Quantification is 2 (log 10 copies/ml).
Time Frame
Day 7
Title
Quantification of SARS-CoV-2 RNA (Phase 2)
Description
Bamlanivimab Agent arms:
Measured as Detected or Undetected from staff-collected NP (nasopharyngeal) swabs. Lower Limit of Detection is 1.4 (log 10 copies/ml).
Non-Bamlanivimab Agent arms:
Measured as below Lower Limit of Quantification (LLoQ) or at/above LLoQ from staff-collected NP (nasopharyngeal) swabs. Lower Limit of Quantification is 2 (log 10 copies/ml).
Time Frame
Day 14
Title
Proportion of Participants With New Adverse Event (AE) ≥ Grade 3 (Phase 2)
Description
AE Severity: Adverse event Severity grading followed Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), corrected Version 2.1, July 2017, which can be found on the DAIDS RSC website at:
https://rsc.niaid.nih.gov/clinical-research-sites/daids-adverse-event-grading-tables.
Grade 1 indicates a mild event
Grade 2 indicates a moderate event
Grade 3 indicates a severe event
Grade 4 indicates a potentially life-threatening event
Grade 5 indicates death
Time Frame
Thru Day 28
Title
Cumulative Incidence of Death Due to Any Cause or Hospitalization Due to Any Cause (Phase 3)
Description
Hospitalization defined as ≥24 hours of acute care in a hospital or similar acute care facility, including Emergency Rooms or temporary facilities instituted to address medical needs of those with severe COVID-19
Time Frame
Thru Day 28
Title
Proportion of Participants With New Adverse Event (AE) ≥ Grade 3 (Phase 3)
Description
AE Severity: Adverse event Severity grading followed Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), corrected Version 2.1, July 2017, which can be found on the DAIDS RSC website at:
https://rsc.niaid.nih.gov/clinical-research-sites/daids-adverse-event-grading-tables.
Grade 1 indicates a mild event
Grade 2 indicates a moderate event
Grade 3 indicates a severe event
Grade 4 indicates a potentially life-threatening event
Grade 5 indicates death
Time Frame
Thru Day 28
Secondary Outcome Measure Information:
Title
COVID-19 Symptom Duration (Phase 3)
Description
Duration defined as the number of days from start of investigational agent to the first of two consecutive days when any symptoms scored as moderate or severe as study entry (pre-treatment) are scored as mild or absent; and any symptoms scored as mild or absent at study entry are scored as absent, AND any symptoms scored as mile or absent at study entry (pre-treatment) are scored as absent. Targeted symptoms are: Feeling feverish; cough, shortness of breath or difficulty breathing; sore throat; body pain or muscle pain/aches; fatigue (low energy); headache, chills, nasal obstruction or congestion (stuffy nose); nasal discharge (runny nose); nausea or vomiting; and diarrhea. Each symptom is scored daily by the participant as absent (score 0), mild (1), moderate (2) or severe (3)
Time Frame
Thru Day 28
Title
Quantification of SARS-CoV-2 RNA (Phase 3)
Description
Measured as quantification (<LLoQ versus ≥LLoQ ) from staff-collected NP (nasopharyngeal) swabs
Time Frame
Day 3
Title
Cumulative Incidence of Death From Any Cause or Hospitalization Due to Any Cause (Phase 2)
Description
Hospitalization defined as ≥24 hours of acute care in a hospital or similar acute care facility, including Emergency Rooms or temporary facilities instituted to address medical needs of those with severe COVID-19
Time Frame
Thru Day 28
Title
Cumulative Incidence of Death From Any Cause, or Hospitalization Due to Any Cause Related to COVID-19 (Phase 3)
Description
Hospitalizations due to any cause deemed unrelated to COVID-19 are excluded. Hospitalization defined as ≥24 hours of acute care in a hospital or similar acute care facility, including Emergency Rooms or temporary facilities instituted to address medical needs of those with severe COVID-19
Time Frame
Thru Day 28
Title
Level of SARS-CoV-2 RNA From NP Swabs (Phase 2)
Description
Measured from staff-collected NP swabs
Time Frame
Thru Day 14
Title
Level of SARS-CoV-2 RNA From NP Swabs (Phase 3)
Description
Measured from staff-collected NP swabs
Time Frame
Day 3
Title
Duration of Targeted Clinical COVID-19 Symptoms (Phases 2 and 3)
Description
Duration defined as the number of days from start of investigational agent to the first of four consecutive days when all symptoms scored as absent. Targeted symptoms are: Feeling feverish; cough, shortness of breath or difficulty breathing; sore throat; body pain or muscle pain/aches; fatigue (low energy); headache, chills, nasal obstruction or congestion (stuffy nose); nasal discharge (runny nose); nausea or vomiting; and diarrhea. Each symptom is scored daily by the participant as absent (score 0), mild (1), moderate (2) or severe (3)
Time Frame
Thru Day 28
Title
COVID-19 Symptom Severity Ranking (Phases 2 and 3)
Description
Symptoms scored daily as absent (score 0), mild (score 1), moderate (score 2) or severe (score 3). Symptoms: feeling feverish, cough, shortness of breath/difficulty breathing at rest/with activity, sore throat, body pain/muscle pain/aches, fatigue, headache, chills, nasal obstruction/congestion, nasal discharge, nausea, vomiting, and diarrhea. Subjects alive and never hospitalized through Day 28: Symptom Severity Ranking=subject-specific AUC (area under curve) joining daily total symptom score associated with COVID-19 disease, over time (through Day 28, counting Day 0 as first day), calculated by trapezoidal rule and rescaled for time by dividing by the total number of trapezoids. Subjects who died within Day 28: Assigned severity score 42; Subjects alive but remaining hospitalized at Day 28: Assigned severity score 41; Subjects alive but no longer hospitalized at Day 28: Assigned severity score 40.
Calculated Severity Score=scale of 0 to 42. Higher value=worse health condition.
Time Frame
From Day 0 thru Day 28
Title
Proportion of Participants With ≥1 Worsening Symptom of COVID-19 (Phases 2 and 3)
Description
Progression of one or more COVID-19-associated symptoms to a worse status than recorded in study diary at study entry, prior to start of investigational product or placebo
Time Frame
Thru Day 28
Title
Time to Self-reported Return to Usual Health (a) (Phases 2 and 3)
Description
Defined as the number of days from start of investigational treatment until the first of two consecutive days that a participant reported return to usual (pre-COVID-19) health as recorded in a participant's study diary
Time Frame
Thru Day 28
Title
Cumulative Incidence of Death Due to Any Cause or Hospitalization Due to Any Cause (Phases 2 and 3)
Time Frame
Day 0 thru Week 24
Title
Cumulative Incidence of Death Due to Any Cause or Hospitalization Due to Any Cause (Phases 2 and 3)
Time Frame
Day 0 thru Week 72
Title
Oxygen Saturation Level (Phases 2 and 3)
Description
Measured by pulse oximeter and categorized as <96% versus ≥96%
Time Frame
Thru Day 28
Title
AUC of SARS-CoV-2 RNA From Site-collected NP Swabs (Phase 2)
Description
Measured by area under the curve (AUC) and above assay lower limit of quantification of quantitative SARS-CoV-2 RNA over time
Time Frame
Thru Day 14
Title
Incidence of New Adverse Event (AE) ≥ Grade 2 (Phases 2 and 3)
Time Frame
Thru Day 28
Title
Incidence of New Adverse Event (AE) ≥ Grade 2 (Phases 2 and 3)
Time Frame
Thru Week 24
Title
Incidence of New Adverse Event (AE) ≥ Grade 3 (Phases 2 and 3)
Time Frame
Thru Week 24
Title
Time to Self-reported Return to Usual Health (b) (Phases 2 and 3)
Description
Defined as the number of days from start of investigational treatment until the first of four consecutive days that a participant reported return to usual (pre-COVID-19) health as recorded in a participant's study diary
Time Frame
Thru Day 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Signed informed consent.
Documentation of laboratory-confirmed SARS-CoV-2 infection, as determined by a molecular (nucleic acid) or antigen test from any respiratory tract specimen (e.g. oropharyngeal, nasopharyngeal (NP), or nasal swab, or saliva) collected ≤240 hours (10 days) prior to study entry. Laboratory-confirmed SARS-CoV-2 infection outside the US must be conducted at a DAIDS-approved laboratory.
Able to begin study treatment no later than 7 days from self-reported onset of COVID-19 related symptom(s) or measured fever, where the first day of symptoms is considered symptom day 0 and defined by the self-reported date of first reported sign/symptom from the following list:
subjective fever or feeling feverish
cough
shortness of breath or difficulty breathing at rest or with activity
sore throat
body pain or muscle pain/aches
fatigue
headache
chills
nasal obstruction or congestion
nasal discharge
loss of taste or smell
nausea or vomiting
diarrhea
temperature > 38°C (100.4°F)
One or more of the following signs/symptoms within 24 hours of participating in the study:
subjective fever or feeling feverish
cough
shortness of breath or difficulty breathing at rest or with activity
sore throat
body pain or muscle pain/aches
fatigue
headache
chills
nasal obstruction or congestion
nasal discharge
loss of taste or smell
nausea or vomiting
diarrhea
temperature > 38°C (100.4°F)
Oxygen levels of ≥92% obtained at rest (adjusted as needed for altitude) by study staff within 24 hours of study entry. For a potential participant who regularly receives chronic supplementary oxygen for an underlying lung condition, their oxygen saturation should be measured while on their standard home oxygen supplementation level.
Participant must agree not to participate in another clinical trial for the treatment of COVID-19 or SARS-CoV-2 during the study period until hospitalization or 28 days after the start of the study, whichever occurs first.
Meet the protocol definition of being at "higher" risk of progression to hospitalization or death (BRII-196/BRII-198).
In Phase III, meeting the protocol definition of being at "higher" risk of progression to hospitalization or death (SNG001, SAB-185, BMS 986414+BMS 986413)
For participants of reproductive potential, negative serum or urine pregnancy test within 48 hours prior to study entry by any clinic or laboratory that has a CLIA certification or its equivalent, or by a point of care (POC)/CLIA-waived test. Note: Participants not of reproductive potential are eligible without requiring the use of a contraceptive method (BRII-196/BRII-198. AZD7442 [IV], AZD7442 [IM], SNG001, Camostat, SAB-185, BMS 986414+BMS 986413).
Participants that engage in sexual activity that may lead to pregnancy in their partner must agree to either remain abstinent or use male contraceptives. They are strongly advised to inform their non-pregnant sexual partners of reproductive potential to use effective contraceptives for 24 weeks after investigational product is administered. Participants with pregnant partners should use condoms during vaginal intercourse through 24 weeks after investigational agent administration. Participants should refrain from sperm donation for 24 weeks after investigational agent administration (BRII-196/BRII-198, AZD7442 [IV], AZD7442 [IM], SAB-185).
Participants that engage in sexual activity that may lead to pregnancy in their partner must agree to either remain abstinent or use male contraceptives for 30 days after investigational agent administration. They are also strongly advised to inform their non-pregnant sexual partners of reproductive potential to sue effective contraceptives for 30 days after investigational agent is administered to the participant. Participants with pregnant partners should use condoms during vaginal intercourse through 30 days after last dose of investigational agent administration. Participants should refrain from sperm donation for 30 days after investigational agent administration (SNG001).
Participants that engage in sexual activity that may lead to pregnancy in their partner must agree to either remain abstinent or use male contraceptives. They are also strongly advised to inform their non-regnant sexual partners of reproductive potential to use effective contraceptives from study entry through 90 days after study treatment. Participants with pregnant partners should use condoms during vaginal intercourse from study entry through 90 days after the last dose of the study treatment. Participants should refrain from sperm donation from study entry through 90 days after the last dose of study treatment (Camostat).
If participating in sexual activity that could lead to pregnancy, participants who are of reproductive potential must agree to use effective contraception for 24 weeks after investigational agent is administered. This would include oral contraceptives, implanted contraceptives, implanted contraceptives, intrauterine devices, and barrier methods.
If participating in sexual activity that could lead to pregnancy, participants who are of reproductive potential must agree to use highly effective contraception for 24 weeks after investigational agent is administered (AZD7442 [IV], AZD7442 [IM], SAB-185).
If participating in sexual activity that could lead to pregnancy, participants who are of reproductive potential must agree to use effective contraception for 30 days after investigational agent is administered (SNG001).
If participating in sexual activity that could lead to pregnancy, participants who are of reproductive potential must agree to use effective contraception for 90 days after the last dose of treatment (Camostat).
If participating in sexual activity that could lead to pregnancy, participants who are of reproductive potential must agree to use highly effective contraception for at least 48 weeks after the investigational agent is administered (BMS 986414+BMS 986413).
Exclusion Criteria:
History of or current hospitalization for COVID-19.
For the current SARS-CoV-2 infection, any positive SARS-CoV-2 nucleic acid or antigen tests from any respiratory tract specimen collected > 240 hours prior to study entry.
Current need for hospitalization or immediate medical attention.
Use of any prohibited medication listed in the protocol and/or use of systemic or inhaled steroids for the purpose of COVID-19 treatment (new or increased dose from chronic baseline) within 30 days prior to study.
Receipt of convalescent COVID-19 plasma or other antibody-based anti-SARS-CoV-2 treatment or prophylaxis at any time prior to study entry.
Receipt of other investigational treatments for SARS-CoV-2 any time before participating in the study (not including drugs approved and taken for other conditions/diseases or COVID-19 vaccines).
Known allergy/sensitivity or hypersensitivity to study drug or placebo.
Any condition requiring surgery up to 7 days before participating in the study, or that is considered life threatening up to 30 days before participating in the study.
Currently pregnant or breastfeeding (BRII-196/BRII-198, AZD7442 [IV], AZD7442 [IM], SNG001, Camostat, SAB-185, BMS 986414+BMS 986413).
In phase II, meeting the protocol definition of being at "higher" risk of progression to hospitalization or death (AZD7442 [IV], AZD7442 [IM], SNG001, Camostat, SAB-185, BMS 986414+BMS 986413).
Inflammatory skin conditions that compromise the safety of intramuscular (IM) injections, or other overlying skin conditions or tattoos that would preclude the assessment of injection site reactions, per the discretion of the investigator (AZD7442 [IM]).
Inflammatory skin conditions that compromise the safety of subcutaneous (SC) injections, or other overlying skin conditions or tattoos that would preclude the assessment of infection site reactions, per the discretion of the investigator (BMS 986414+BMS 986413).
History of coagulopathy which, in the opinion of the investigator, would preclude IM injection, or use of oral or injectable anticoagulants (protocol provides more information on prohibited medications) (AZD7442 [IM]).
Use of or need for chronic supplemental oxygen (SNG001).
Known severe liver disease prior to enrollment (defined as ALT or AST > 5 times upper limit of normal or end stage liver disease with Child-Pugh Class C or Child-Pugh-Turcotte score ≥ 10) (Camostat).
Known severe kidney disease prior to enrollment (defined as estimated glomerular filtration rate (eGFR) <30 ml/min/1.73m² or on renal-replacement therapy such as peritoneal dialysis or hemodialysis (Camostat)
Other investigational drug protocol-defined inclusion/exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Smith, MD, MAS
Organizational Affiliation
University of California, San Diego
Official's Role
Study Chair
Facility Information:
Facility Name
Pinnacle Research Group (Site 1082), 321 E. 10th Street
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207-5707
Country
United States
Facility Name
North Alabama Research Center LLC (Site 1194), 721 W. Market St., Ste. B
City
Athens
State/Province
Alabama
ZIP/Postal Code
35611-2456
Country
United States
Facility Name
University of Alabama at Birmingham (Site 1005), 908 20th Street South
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Cullman Clinical Trials (Site 1140), 501 Clark St. NE.
City
Cullman
State/Province
Alabama
ZIP/Postal Code
35055-1921
Country
United States
Facility Name
Jasper Summit Research, LLC. (Site 1056), 1280 Summit
City
Jasper
State/Province
Alabama
ZIP/Postal Code
35501-0102
Country
United States
Facility Name
Absolute Clinical Research, LLC. (Site 1186), 7725 North 43rd Avenue, Ste. 211
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85051
Country
United States
Facility Name
University of Arizona (Site 1043), 1501 N. Campbell Ave., Rm. 6410
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724-0001
Country
United States
Facility Name
Omnibus Clinical Research (Site 1253), 3340 W. Ball Road, Ste. I
City
Anaheim
State/Province
California
ZIP/Postal Code
92804-3729
Country
United States
Facility Name
Franco A. Felizarta MD (Site 1174), 3535 San Dimas St.
City
Bakersfield
State/Province
California
ZIP/Postal Code
93301-1661
Country
United States
Facility Name
Clearview Medical Research LLC. (Site 1251), 2714 Hidaway Ave., Ste. 103
City
Canyon Country
State/Province
California
ZIP/Postal Code
91351-4138
Country
United States
Facility Name
St. Jude Heritage Medical Group (Site 1093), 2151 N. Harbor Blvd.
City
Fullerton
State/Province
California
ZIP/Postal Code
92835-3820
Country
United States
Facility Name
University of California San Diego (Site 1160), 9350 Campus Point Drive, Perlman Cancer Cancer
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Fadi A. Haddad, MD, Inc. (Site 1146), 8860 Center Dr., Ste. 320
City
La Mesa
State/Province
California
ZIP/Postal Code
91942-7001
Country
United States
Facility Name
Atella Clinical Research (Site 1111), 5451 La Palma Avenue
City
La Palma
State/Province
California
ZIP/Postal Code
90623
Country
United States
Facility Name
Loma Linda University Health (Site 1110), 11374 Mountain View, Dover Bldg, Ste. C
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
University of Southern California (Site 1057), 1300 N. Mission Rd., Rm 349
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033-1021
Country
United States
Facility Name
UCLA CARE Center (Site 1003), 11075 Santa Monica Blvd., Suite 100
City
Los Angeles
State/Province
California
ZIP/Postal Code
90035
Country
United States
Facility Name
Science 37, Inc. (Site 1124), 12121 Bluff Creek Dr., Ste. 100
City
Los Angeles
State/Province
California
ZIP/Postal Code
90094-2994
Country
United States
Facility Name
VA Northern California Health Care System (NAVREF) (Site 1137), 10535 Hospital Way
City
Mather
State/Province
California
ZIP/Postal Code
95655-4200
Country
United States
Facility Name
Central Valley Research, LLC (Site 1085), 400 E. Orangeburg Ave., Ste. 5
City
Modesto
State/Province
California
ZIP/Postal Code
95350-5365
Country
United States
Facility Name
Hoag Memorial Hospital Presbyterian (Site 1200), 1 Hoag Dr.
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663-4126
Country
United States
Facility Name
Valley Clinical Research, Inc. (Site 1059), 18433 Roscoe Blvd., Ste 210
City
Northridge
State/Province
California
ZIP/Postal Code
91325-4138
Country
United States
Facility Name
University of California Irvine (Site 1083), 843 Health Sciences Road
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
FOMAT Medical Research (Site 1136), 300 South A Street
City
Oxnard
State/Province
California
ZIP/Postal Code
93030
Country
United States
Facility Name
Eisenhower Medical Center (Site 1040), 39000 Bob Hope Drive
City
Rancho Mirage
State/Province
California
ZIP/Postal Code
92270-3221
Country
United States
Facility Name
Paradigm Research (Site 1150), 3652 Eureka Way
City
Redding
State/Province
California
ZIP/Postal Code
96001-0172
Country
United States
Facility Name
Riverside Medical Clinic (Site 1232), 7117 Brockton Ave.
City
Riverside
State/Province
California
ZIP/Postal Code
92506-2658
Country
United States
Facility Name
University of California Davis Medical Center (Site 1097), 2315 Stockton Blvd.
City
Sacramento
State/Province
California
ZIP/Postal Code
95817-2201
Country
United States
Facility Name
Premier Urgent Care Centers of California, Inc. (Site 1176), 284 E. Highland Ave.
City
San Bernardino
State/Province
California
ZIP/Postal Code
92404
Country
United States
Facility Name
University of California San Diego (Site 1002), 220 Dickinson Street
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Zion Medical Center (Site 1063), 4647 Zion Avenue
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
VA San Diego Health System (Stie 1127), 3350 La Jolla
City
San Diego
State/Province
California
ZIP/Postal Code
92161-0002
Country
United States
Facility Name
University of California San Francisco (Site 1009), 995 Potrero Ave., Building 80, Ward 84
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
San Francisco Research Institute (Site 1210), 2435 Ocean Ave.
City
San Francisco
State/Province
California
ZIP/Postal Code
94127-2606
Country
United States
Facility Name
Stanford University (Site 1213), 1201 Welch Road
City
Stanford
State/Province
California
ZIP/Postal Code
94305-5102
Country
United States
Facility Name
Millennium Clinical Trials (Site 1260), 550 Saint Charles Dr., Ste. 208
City
Thousand Oaks
State/Province
California
ZIP/Postal Code
91360-3994
Country
United States
Facility Name
Office of Ramesh V. Nathan, MD (Site 1073), 2220 Lynn Rd., Ste. 301
City
Thousand Oaks
State/Province
California
ZIP/Postal Code
91360-8005
Country
United States
Facility Name
Harbor UCLA (Site 1022), 1124 West Carson Street
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Allianz Research Institute Inc. (Site 1159), 14120 Beach Blvd., Ste. 101
City
Westminster
State/Province
California
ZIP/Postal Code
92683-4454
Country
United States
Facility Name
University of Colorado (Site 1007), 12401 East 17th Avenue
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
UConn - Institute for Collaboration on Health (Site 1169), 2006 Hillside Rd., Unit 1248
City
Storrs
State/Province
Connecticut
ZIP/Postal Code
06269-1248
Country
United States
Facility Name
Whitman-Walker Health (Site 1027), 1337 R Street NW.
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20009
Country
United States
Facility Name
Imagine Research of Palm Beach County (Site 1157), 709 S. Federal Hwy., Ste. 2
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33435-5610
Country
United States
Facility Name
Bradenton Research Center Inc. (Site 1109), 3924 9th Ave. W
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34205-1704
Country
United States
Facility Name
Synergy Healthcare (Site 1099), 300 Riverside Drive E., Ste. 1350
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34208-1004
Country
United States
Facility Name
Cardiology Physicians, P.A. (Site 1180), 305 Memorial Medical Pkwy., Ste. 301
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32117-5157
Country
United States
Facility Name
Midland Florida Clinical Research Center LLC (Site 1130), 665 Peachwood Drive
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720-0920
Country
United States
Facility Name
Integrity Clinical Research (Site 1214), 3901 NW 79th Ave.
City
Doral
State/Province
Florida
ZIP/Postal Code
33166-6508
Country
United States
Facility Name
Universal Axon Clinical Research (Site 1077), 3650 NW 82nd Ave.
City
Doral
State/Province
Florida
ZIP/Postal Code
33166-6658
Country
United States
Facility Name
EMINAT Research (Site 1202), 2500 E. Commercial Blvd.
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Holy Cross Health (Site 1072), 4725 North Federal Highway
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
North Florida / South Georgia Veterans Health System (Site 1133), 1601 SW Archer Rd.
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608-1135
Country
United States
Facility Name
University of Florida (Site 1047), 1600 SW. Archer Rd.
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610-3003
Country
United States
Facility Name
NW FL Clinical Research Group, LLC. (Site 1046), 400 Gulf Breeze Parkway
City
Gulf Breeze
State/Province
Florida
ZIP/Postal Code
32561
Country
United States
Facility Name
Indago Research and Health Center (Site 1050), 3700 W. 12th Ave., Ste. 300
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012-4174
Country
United States
Facility Name
AGA Clinical Trials (Site 1026), 900 West 49th Street
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Community Research of South Florida (Site 1197), 7100 W. 20th Ave., Ste. 403
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016-1811
Country
United States
Facility Name
New Generation Medical Research (Site 1204), 7600 W. 20th Ave., Ste. 106
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016-1895
Country
United States
Facility Name
Best Quality Research, Inc. (Site 1237), 2387 W. 68th St., Ste. 403
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016-6890
Country
United States
Facility Name
Innovative Health Medical Center (Site 1222), 6750 Taft Street
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
University of Florida Jacksonville (Site 1039), 655 West 8th Street
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Mayo Clinic Jacksonville (Site 1149), 4500 San Pablo Rd. S.
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224-1865
Country
United States
Facility Name
QC Trials (Site 1117), 300 W. 41st Street, Ste. 203
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140-3627
Country
United States
Facility Name
Lakes Research (Site 1037), 5801 NW 151 Street
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
Savin Medical Group, LLC. (Site 1212), 5789B NW. 151st Street
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
Amber Clinical Research, LLC. (Site 1206), 9000 NE. 2nd Avenue
City
Miami Shores
State/Province
Florida
ZIP/Postal Code
33138
Country
United States
Facility Name
Gonzalez MD & Aswad MD Health Services (Site 1238), 3401 NW. 7th Street
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
Clintex Research Group, Inc. (Site 1231), 590 SW. 27th Ave.
City
Miami
State/Province
Florida
ZIP/Postal Code
33135-2906
Country
United States
Facility Name
Advance Medical Research Center (Site 1193) 330 SW. 27th Ave., Ste. 701
City
Miami
State/Province
Florida
ZIP/Postal Code
33135-2968
Country
United States
Facility Name
University of Miami Miller School of Medicine CoVID Unit (Site 1068), 1425 NW. 10th Ave.
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Florida International Medical Research (Site 1239), 1890 S. Red Rd., Ste. 103
City
Miami
State/Province
Florida
ZIP/Postal Code
33155-2164
Country
United States
Facility Name
D&H National Research Centers (Site 1205), 8485 Bird Road
City
Miami
State/Province
Florida
ZIP/Postal Code
33155-3244
Country
United States
Facility Name
Allied Biomedical Research Institute (Site 1227), 7100 SW. 47th St., Ste. 220
City
Miami
State/Province
Florida
ZIP/Postal Code
33155-4630
Country
United States
Facility Name
Miami Clinical Research (Site 1089), 2400 SW. 69th Ave.
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Research Institute of South Florida, Inc. (Site 1201), 9835 SW. 72nd Street, Ste. 201
City
Miami
State/Province
Florida
ZIP/Postal Code
33173-4648
Country
United States
Facility Name
RM Medical Research, Inc. (Site 1230), 10346 W. Flagler St.
City
Miami
State/Province
Florida
ZIP/Postal Code
33174-1746
Country
United States
Facility Name
Pro Live Medical Research Corp (Site 1219), 12781 SW. 42nd Street
City
Miami
State/Province
Florida
ZIP/Postal Code
33175-3437
Country
United States
Facility Name
Miami Dade Medical Research Institute, LLC (Site 1223), 8955 SW. 87th Ct.
City
Miami
State/Province
Florida
ZIP/Postal Code
33176-2230
Country
United States
Facility Name
Bravo Health Care Center (Site 1221), 1440 79 Street
City
North Bay Village
State/Province
Florida
ZIP/Postal Code
33141
Country
United States
Facility Name
Orlando Immunology Center (Site 1045), 1707 North Mills Avenue
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Clintheory (Site 1203), 7350 Sandlake Commons Blvd.
City
Orlando
State/Province
Florida
ZIP/Postal Code
32819
Country
United States
Facility Name
IMIC, Inc. (Site 1141), 18320 Franjo Rd
City
Palmetto Bay
State/Province
Florida
ZIP/Postal Code
33157-5503
Country
United States
Facility Name
Family Clinical Trials (Site 1236), 1601 N. Palm Ave., Ste. 102
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33026-3240
Country
United States
Facility Name
Physician Care Clinical Research, LLC. (Site 1242), 1617 S. Tuttle Ave., Ste. 1A
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239-3132
Country
United States
Facility Name
Bassetti Medical Research, Inc. (Site 1158), 5825 US Highway 27 N.
City
Sebring
State/Province
Florida
ZIP/Postal Code
33870-1216
Country
United States
Facility Name
DBC Research (Site 1188), 7707 N. University Dr., Ste. 106
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321-2954
Country
United States
Facility Name
ETNA Medical Center (Site 1225), 7401 N. University Drive
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33342
Country
United States
Facility Name
Moore Clinical Research, Inc. (Site 1164), 4257 W. Kennedy Blvd.
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609-2230
Country
United States
Facility Name
Tampa General Hospital Family Care Center Healthpark (Site 1088), 5802 N. 30th Street
City
Tampa
State/Province
Florida
ZIP/Postal Code
33610-1469
Country
United States
Facility Name
Infectious Disease Consultants of the Treasure Coast (Site 1171), 3735 11th Cir., Ste. 201
City
Vero Beach
State/Province
Florida
ZIP/Postal Code
32960-4889
Country
United States
Facility Name
AIDS Research and Treatment Center of the Treasure Coast (Site 1095), 981 37th Place
City
Vero Beach
State/Province
Florida
ZIP/Postal Code
32960
Country
United States
Facility Name
Triple O Research Institute PA (Site 1121), 2580 Metrocentre Blvd., Ste. 4
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407-3100
Country
United States
Facility Name
The Ponce de Leon Center (site 1015), 341 Ponce De Leon Avenue Northeast
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Rare Disease Research, LLC. (Site 1248), 1891 Howell Mill Rd.NW, Ste. B
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30318-2512
Country
United States
Facility Name
Agile Clinical Rsearch Trials, LLC (Site 1051), 750 Hammond Drive
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Balanced Life Health Care Solutions/SKYCRNG (Site 1191), 2033 Buford Hwy., Ste. 109
City
Buford
State/Province
Georgia
ZIP/Postal Code
30518-8802
Country
United States
Facility Name
IACT Health (Site 1035), 800 Talbotton Road
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Clintheory (Site 1254), 4300 Pleasant Hill Road
City
Duluth
State/Province
Georgia
ZIP/Postal Code
30096
Country
United States
Facility Name
One Health Research Clinic, Inc. (Site 1250), 5880 Live Oak Pkwy, Ste. 160
City
Norcross
State/Province
Georgia
ZIP/Postal Code
30093
Country
United States
Facility Name
Renew Health Clinical Research, LLC. (Site 1161), 1550 Janmar Rd.
City
Snellville
State/Province
Georgia
ZIP/Postal Code
30078-5779
Country
United States
Facility Name
John A. Burns School of Medicine UH Clinics at Kakaako (Site 1177), 651 Ilalo St.
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Snake River Research, PLLC (Site 1120), 2900 Cortez Ave.
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404-7554
Country
United States
Facility Name
Metro Infectious Disease Consultants (Site 1106), 901 McClintock Dr., Ste. 201
City
Burr Ridge
State/Province
Illinois
ZIP/Postal Code
60527-0872
Country
United States
Facility Name
Chicago Clinical Research Institute (Site 1132), 611 W. Roosevelt Rd.
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60607-4911
Country
United States
Facility Name
Northwestern University (Site 1025), 645 North Michigan Ave
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Rush University Medical Center (Site 1017), 600 Paulina St.
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Illinois at Chicago (Site 1147), 835 South Wood Street
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Chicago (Site 1064), 5841 S. Maryland Ave.
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1443
Country
United States
Facility Name
Great Lakes Clinical Trials (Site 1049), 5149 N. Ashland Ave.
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640-2831
Country
United States
Facility Name
Investigators Research Group, LLC. (Site 1170), 321 E. Northfield Dr., Ste. 100
City
Brownsburg
State/Province
Indiana
ZIP/Postal Code
46112-2415
Country
United States
Facility Name
Roudebush VA Medical Center (Site 1217), 550 University Blvd
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-5149
Country
United States
Facility Name
University of Kansas Medical Center (Site 1042), 3901 Rainbow Boulevard
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
MedPharmics (Site 1065), 3800 Houma Blvd.
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Clinical Trials of America, LLC. (Site 1245) 3201 Armand Street
City
Monroe
State/Province
Louisiana
ZIP/Postal Code
71201
Country
United States
Facility Name
New Orleans Adolescent Trials Unit (Site 1028), 1440 Canal St., Suite 904
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112-2703
Country
United States
Facility Name
Louisiana State University Health Sciences Center (Site 1153), 2000 Canal Street
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112-3018
Country
United States
Facility Name
Ochsner Clinic Foundation (Site 1218), 1514 Jefferson Highway
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Baltimore VA Medical Center (Site 1258), 10 N. Greene St.
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201-1524
Country
United States
Facility Name
Johns Hopkins University (Site 1006), 1830 East Monument Street
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
Walter Reed Army Institute of Research (Site 1118), 503 Robert Grant Ave.
City
Silver Spring
State/Province
Maryland
ZIP/Postal Code
20910-7500
Country
United States
Facility Name
Massachusetts General Hospital (Site 1016), 55 Fruit Street
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Beth Israel Deaconess Medical Center (Site 1166), 110 Francis Street
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Brigham and Women's Hospital - Therapeutics Clinical Research Site (Site 1023), 75 Francis Street
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
University of Massachusetts Medical School (Site 1054), 55 Lake Avenue N.
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655-0002
Country
United States
Facility Name
Vida Clinical Studies (Site 1244), 3815 Pelham Street
City
Dearborn
State/Province
Michigan
ZIP/Postal Code
48124
Country
United States
Facility Name
Revive Research Institute (Site 1257), 32255 Northwestern Hwy.
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334-1566
Country
United States
Facility Name
Revival Research Corporation (Site 1256), 13409 East 14 Mile Road
City
Sterling Heights
State/Province
Michigan
ZIP/Postal Code
48312
Country
United States
Facility Name
Memorial Hospital at Gulfport (Site 1104), 4500 13th Street
City
Gulfport
State/Province
Mississippi
ZIP/Postal Code
39501
Country
United States
Facility Name
MedPharmics, LLC. (Site 1032), 15190 Community Rd.
City
Gulfport
State/Province
Mississippi
ZIP/Postal Code
39503
Country
United States
Facility Name
University of Missouri Health Care System (Site 1224), 1 Hospital Drive
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212-1000
Country
United States
Facility Name
Hannibal Clinic (Site 1129), 100 Medical Drive
City
Hannibal
State/Province
Missouri
ZIP/Postal Code
63401
Country
United States
Facility Name
Washington University School of Medicine (Site 1008), 620 South Taylor, Suite 200
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Bozeman Health Deaconess Hospital (Site 1115), 931 Highland Blvd, Ste. 3103
City
Bozeman
State/Province
Montana
ZIP/Postal Code
59715-6911
Country
United States
Facility Name
Mercury Street Medical Group (Site 1074), 300 W. Mercury St.
City
Butte
State/Province
Montana
ZIP/Postal Code
59701-1652
Country
United States
Facility Name
Quality Clinical Research (Site 1112), 10040 Regency Circle
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Las Vegas Medical Research (Site 1048), 8530 W. Sunset Rd.
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89113-2215
Country
United States
Facility Name
AXCES Research Group (Site 1152), 531 Harkle Road
City
Santa Fe
State/Province
New Mexico
ZIP/Postal Code
87505
Country
United States
Facility Name
Bronx Prevention Research Center (Site 1108), 390 East 158th Street
City
Bronx
State/Province
New York
ZIP/Postal Code
10451
Country
United States
Facility Name
Lincoln Hospital (Site 1092), 249 East 149th Street
City
Bronx
State/Province
New York
ZIP/Postal Code
10451
Country
United States
Facility Name
Urban Health Plan, Inc. (Site 1243), 1065 Southern Blvd
City
Bronx
State/Province
New York
ZIP/Postal Code
10459-2417
Country
United States
Facility Name
Jacobi Medical Center (Site 1105), 1400 Pelham Parkway South
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
James J. Peters VA Medical Center (Site 1053), 130 West Kingsbridge Road
City
Bronx
State/Province
New York
ZIP/Postal Code
10468
Country
United States
Facility Name
Maimonides Medical Center (Site 1138), 4802 10th Avenue
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11219-2916
Country
United States
Facility Name
University at Buffalo, Emergency Medicine (Site 1172), 77 Goodell Street
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Facility Name
Flushing Hospital Medical Center (Site 1067), 4500 Parsons Blvd
City
Flushing
State/Province
New York
ZIP/Postal Code
11355-2205
Country
United States
Facility Name
Jamaica Hospital Medical Center (Site 1066), 8900 Van Wyck Expressway
City
Jamaica
State/Province
New York
ZIP/Postal Code
11418-2832
Country
United States
Facility Name
Columbia Partnership for Prevention and Control of HIV/AIDS CTU (Site 1019), Columbia University Irving Medical Center, Department of Medicine - Division of Infectious Diseases, 180 Fort Washington Avenue, HP6 - Rm 604
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Cornell Clinical Trials Unit (Site 1011), NewYork-Presbyterian Hospital-Weill Cornell Medical Center, 525 East 68th Street
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Canton-Potsdam Hospital (Site 1076), 50 Leroy Street
City
Potsdam
State/Province
New York
ZIP/Postal Code
13676-1786
Country
United States
Facility Name
University of Rochester (Site 1010), 601 Elmwood Ave
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
SUNY Stony Brook NICHD (Site 1094), HSC L-02, Rm. 142 C
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
University of North Carolina at Chapel Hill (Site 1001), 130 Mason Farm Rd., Bioinformatics Bldg, 2nd Floor
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
Carolina Clinical Research (Site 1167), 9040 Nations Ford Rd.
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
38273-5716
Country
United States
Facility Name
Research Carolina Elite (Site 1247), 7480 Waterside Loop Road, Suite 201
City
Denver
State/Province
North Carolina
ZIP/Postal Code
28037
Country
United States
Facility Name
Duke University Medical Center (Site 1041), 40 Duke Medicine Circle
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Carteret Medical Group, LLC. (Site 1249), 302 Medical Park Ct.
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
Country
United States
Facility Name
Wake Forest University Health Sciences (Site 1038), 1 Medical Center Boulevard
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-0001
Country
United States
Facility Name
Sanford Health (Site 1084), 801 Broadway N.
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58102-3641
Country
United States
Facility Name
The Christ Hospital (Site 1119), 2123 Auburn Avenue
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Case Western Reserve University (Site 1033), 2061 Cornell Road
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5083
Country
United States
Facility Name
MetroHealth Medical Center (Site 1195), 2500 Metrohealth Dr.
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109-1900
Country
United States
Facility Name
Ohio State University Medical Center (Site 1020), 480 Medical Center Drive
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Cincinnati CRS (Site 1004), University of Cincinnati, University Hospital, 200 Albert Sabin Way
City
Ohio City
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
STAT Research (Site 1107), 66 Remick Blvd.
City
Springboro
State/Province
Ohio
ZIP/Postal Code
45066-9168
Country
United States
Facility Name
Ascension St. John Clinical Research Institute (Site 1090), 1725 East 19th Street
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Providence Portland Medical Center (Site 1098), 4805 NE. Glisan Street
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213-2933
Country
United States
Facility Name
Kaiser Permanente Center for Health Research (Site 1079), 3800 N. Interstate Ave.
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227-1110
Country
United States
Facility Name
Portland VA Medical Center (Site 1131), 3710 SW US Veterans Hospital Rd.
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239-2964
Country
United States
Facility Name
Oregon Health and Science University (Site 1259), 3181 SW. 10th Avenue
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239-3015
Country
United States
Facility Name
Doylestown Hospital (Site 1122), 595 W. State Street
City
Doylestown
State/Province
Pennsylvania
ZIP/Postal Code
18901-2554
Country
United States
Facility Name
University of Pennsylvania (Site 1031), 3400 Spruce Street
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
The University of Pittsburgh (Site 1018), 3471 5th Ave.
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213-3215
Country
United States
Facility Name
Veterans Affairs Pittsburgh Healthcare System (Site 1070), University Drive C.
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15240
Country
United States
Facility Name
The Miriam Hospital Clinical Research Site (1142), 164 Summit Avenue
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
Medtrial, LLC (Site 1134), 1718 Saint Julian Pl., Ste. 2
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29204-2410
Country
United States
Facility Name
Clinovacare Medical Clinical Research Center (Site 1211), 160 Medical Circle Suite D
City
West Columbia
State/Province
South Carolina
ZIP/Postal Code
29169
Country
United States
Facility Name
American Indian Clinical Trials Research Network (Site 1148), 717 Meade Street
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
Sanford USD Medical Center (Site 1078), 1305 W. 18th St.
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105-0401
Country
United States
Facility Name
Clinical Trials Center of Middle Tennessee (Site 1183), 100 Covey Drive
City
Franklin
State/Province
Tennessee
ZIP/Postal Code
37067
Country
United States
Facility Name
Vanderbilt Therapeutics Clinical Research (Site 1013), Vanderbilt Health One Hundred Oaks, 719 Thompson Ln., Ste 47183
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37204-4718
Country
United States
Facility Name
Saint Hope Foundation Inc. (Site 1100), 6800 West Loop Street, Ste. 560
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401-4516
Country
United States
Facility Name
South Texas Medical Research Institute, Inc./TTS Research (Site 1198), 1420 River Road
City
Boerne
State/Province
Texas
ZIP/Postal Code
78006
Country
United States
Facility Name
PanAmerican Clinical Research, LLC. (Site 1069), 1416 Palm Blvd.
City
Brownsville
State/Province
Texas
ZIP/Postal Code
78520-7256
Country
United States
Facility Name
Trinity Health and Wellness Center (Site 1030), 219 Sunset Avenue
City
Dallas
State/Province
Texas
ZIP/Postal Code
75208
Country
United States
Facility Name
UT Southwestern HIV/ID Clinical Trials Unit (Site 1208), 1936 Amelia Court
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Doctors Hospital at Renaissance Health Institute for Research and Development (Site 1145), 5323 S. McColl Rd.
City
Edinburg
State/Province
Texas
ZIP/Postal Code
78539
Country
United States
Facility Name
Sealy Institute for Vaccine Sciences Clincial Trials Program (Site 1044), 400 Harborside Drive
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555-0001
Country
United States
Facility Name
Rheumatology Center of Houston (Site 1252), 1200 Binz St., Ste. 1495
City
Houston
State/Province
Texas
ZIP/Postal Code
77004-6938
Country
United States
Facility Name
Lyndon B. Johnson Hospital (Site 1014), 5656 Kelley Street
City
Houston
State/Province
Texas
ZIP/Postal Code
77026-1967
Country
United States
Facility Name
University of Texas Health Science Center at Houston (Site 1055), 6431 Fannin Street, Ste. 2.112
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-1501
Country
United States
Facility Name
Houston Methodist Hospital (Site 1123), 6565 Fannin Street
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-2703
Country
United States
Facility Name
Dynamic Medical Research Group (Site 1081), 8314 Southwest Fwy
City
Houston
State/Province
Texas
ZIP/Postal Code
77074-1603
Country
United States
Facility Name
Fairway Medical Clinic (Site 1156), 4910 Telephone Road
City
Houston
State/Province
Texas
ZIP/Postal Code
77087
Country
United States
Facility Name
Houston Heart and Vascular Associates (Site 1215), 1485 FM 1960 Bypass R. E., Ste. 100
City
Humble
State/Province
Texas
ZIP/Postal Code
77338
Country
United States
Facility Name
SMS Clincial Research, LLC. (Site 1060), 1210 N. Galloway Ave.
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75149-2438
Country
United States
Facility Name
Epic Medical Research, LLC (Site 1233), 106 Plaza Drive
City
Red Oak
State/Province
Texas
ZIP/Postal Code
75154
Country
United States
Facility Name
San Antonio Military Medical Center (Site 1173), 3551 Roger Brooke Dr.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78234-4504
Country
United States
Facility Name
Inova Fairfax Medical Campus (Site 1029), 3300 Gallows Road
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042-3307
Country
United States
Facility Name
Clinical Research Partners LLC (Site 1196), 7110 Forest Ave., Ste. 201
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23226-3787
Country
United States
Facility Name
EvergreenHealth (Site 1080), 12040 NE 128th Street, Ste MS-77
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98034-3013
Country
United States
Facility Name
University of Washington ACTU (Site 1012), Harborview Medical Center, 325 9th Ave.
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Providence Medical Research Center (Site 1075), 105 W. 8th Ave., Ste. 6050W
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204-2312
Country
United States
Facility Name
Hershel Woody Williams VA Medical Center (Site 1128), 1540 Spring Valley Drive
City
Huntington
State/Province
West Virginia
ZIP/Postal Code
25704
Country
United States
Facility Name
West VA University, Mary Babb Randolph Cancer Center (Site 1178), 1 Medical Center Drive
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506-1200
Country
United States
Facility Name
Vida Clinical Studies (Site 1246), 5757 West Oklahoma Avenue
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53219
Country
United States
Facility Name
Medical College of Wisconsin, Inc. (Site 1036), 8701 Watertown Plank Road
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Allegiance Research Specialists (Site 1162), 2645 N. Mayfair Rd., Ste. 200
City
Wauwatosa
State/Province
Wisconsin
ZIP/Postal Code
53226-1304
Country
United States
Facility Name
Instituto Médico Platense (Site 3011), Avenida 51 335
City
La Plata
State/Province
Buenos Aires
ZIP/Postal Code
B1900AVG
Country
Argentina
Facility Name
Fundación Sanatorio Güemes (Site 3001), Francisco Acuña de Figueroa 1240
City
Buenos Aires
State/Province
Ciudad Autónoma De Buenos Aires
ZIP/Postal Code
C1180AAX
Country
Argentina
Facility Name
Instituto Médico Río Cuarto (Site 3005), Hipólito Yrigoyen 1020
City
Río Cuarto
State/Province
Córdoba
ZIP/Postal Code
5800
Country
Argentina
Facility Name
Instituto Médico de la Fundación Estudios Clínicos (Site 3009), Italia 428
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2013DTC
Country
Argentina
Facility Name
Clínica Adventista Belgrano (Site 3007), Estomba 1710
City
Ciudad Autonoma de Buenos Aires
ZIP/Postal Code
C1430EGF
Country
Argentina
Facility Name
Instituto Ave Pulmo (Site 3006), Carlos M. Alvear 3345
City
Mar Del Plata
ZIP/Postal Code
B7602DCK
Country
Argentina
Facility Name
Hospital Universitario Austral (Site 3004), Av. Juan Domingo Peron, Derqui
City
Pilar
ZIP/Postal Code
B1629ODT
Country
Argentina
Facility Name
L2 Ip - Instituto de Pesquisas Clinicas Ltda (Site 4008), SGAS 613, Conjunto E, Lote 95, Sala 6
City
Brasília
State/Province
Distrito Federal
ZIP/Postal Code
70200-730
Country
Brazil
Facility Name
Hospital Das Clinicas Da Universidade Federal de Minas Gerais (Site 4001), Avenida Alfredo Balena 190
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30130-100
Country
Brazil
Facility Name
SOM Federal University Minas Gerais Brazil (Site 4002), Avenida Alfredo Balena 190
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30130-100
Country
Brazil
Facility Name
Hospital Nossa Senhora da Conceicao (Site 4004), Avenida Francisco Trein 596
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
91850-200
Country
Brazil
Facility Name
Hospital Dia do Pulmão (Site 4007), Rua Engenheiro Paul Werner, 1141
City
Blumenau
State/Province
Santa Catarina
ZIP/Postal Code
89030-101
Country
Brazil
Facility Name
Hospital Das Clinicas da Faculdade de Medicina de Ribeirão Preto (Site 4003), Avenida Bandeirantes 3900, Campus Universitário
City
Ribeirão Preto
State/Province
São Paulo
ZIP/Postal Code
14048-900
Country
Brazil
Facility Name
Instituto de Pesquisa Clínica Evandro Chagas (Site 4005), Avenida Brasil, 4365
City
Rio De Janeiro
ZIP/Postal Code
21040-360
Country
Brazil
Facility Name
Hospital E Maternidade Celso Pierro (Site 4006), Avenue John Boyd Dunlop S/n
City
São Paulo
ZIP/Postal Code
13059-900
Country
Brazil
Facility Name
Medical Arts Health Research Group (Site 2003), 360-1855 Kirschner Rd.
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 4N7
Country
Canada
Facility Name
Centro Medico Militar (Site 9401), Finca El Palomar, Acatan, Sta. Rosita Zona 16
City
Ciudad De Guatemala
ZIP/Postal Code
01011
Country
Guatemala
Facility Name
CIMAB SA de CV (Site 6002), Francisco I Madero 270 Sur
City
Torreon
State/Province
Coahuila
ZIP/Postal Code
27000
Country
Mexico
Facility Name
Oaxaca Site Management Organization (Site 6004), Calle Humboldt 302, Colonia Centro
City
Oaxaca
State/Province
Distrito Federal
ZIP/Postal Code
68000
Country
Mexico
Facility Name
Instituto Jalisciense de Investigacion Clinica SA de CV (Site 6005), Penitenciaria Numero 20, Colonia Centro
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44100
Country
Mexico
Facility Name
Centro de Investigación Farmacéutica Especializada de Occidente (Site 6006), Av. Vallarta 1670, Piso 2 PH1, Colonia Americana
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44160
Country
Mexico
Facility Name
Neurociencias Estudios Clinicos S.C. (Site 6008), Boulevard Alfonso G. Calderon, 2193 int 2 A desarrollo urbano 3 rios
City
Culiacán
State/Province
Sinaloa
ZIP/Postal Code
80020
Country
Mexico
Facility Name
Hospital Civil De Culiacan (Site 6011), Avenida Álvaro Obregón 1422
City
Culiacán
State/Province
Sinaloa
ZIP/Postal Code
80030
Country
Mexico
Facility Name
Eme Red Hospitalaria (Site 6010), Calle 33 No. 496
City
Mérida
State/Province
Yucatán
ZIP/Postal Code
97000
Country
Mexico
Facility Name
Kohler and Milstein Research (Site 6013), Avenida Colón 197, García Ginerés
City
Mérida
State/Province
Yucatán
ZIP/Postal Code
97070
Country
Mexico
Facility Name
De La Salle Health Sciences Institute (Site 9504), Gov. Mangubat Avenue
City
Cavite City
State/Province
Cavite
ZIP/Postal Code
4114
Country
Philippines
Facility Name
Makati Medical Center (Site 9502), No. 2 Amorsolo Street, Legaspi Village
City
Makati City
State/Province
National Capital Region
ZIP/Postal Code
1229
Country
Philippines
Facility Name
Asian Hospital and Medical Center (Site 9503), 2205 Civic Drive
City
Muntinlupa
State/Province
National Capital Region
ZIP/Postal Code
1780
Country
Philippines
Facility Name
Puerto Rico AIDS Clinical Trials Unit (Site 1024), Proyecto ACTU Biomedical Building II
City
San Juan
ZIP/Postal Code
00935
Country
Puerto Rico
Facility Name
Peermed Clinical Trial Center (Site 9215), Corner of Voortrekker and Monument Roads
City
Kempton Park
State/Province
Ekurhuleni, Gauteng
ZIP/Postal Code
1619
Country
South Africa
Facility Name
Worthwhile Clinical Trials (Site 9214), No. 1 Mowbray Avenue
City
Benoni
State/Province
Gauteng
ZIP/Postal Code
1501
Country
South Africa
Facility Name
The Aurum Institute Tembisa Clinical Research Site (Site 9217), Cnr Flint Mazibuko / Rev RTJ Namane Drive
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
1632
Country
South Africa
Facility Name
Roodepoort Medicross (Site 9220), 54 Ontdekkers Road
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
1724
Country
South Africa
Facility Name
Soweto ACTG CRS (Site 9203), Chris Hani Road
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
1862
Country
South Africa
Facility Name
Helen Joseph Hospital (Site 9201), Perth Road
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
9092
Country
South Africa
Facility Name
Setshaba Research Centre (Site 9205), 2088 Block H
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0152
Country
South Africa
Facility Name
Into Research (Site 9210), Totius Street
City
Tshwane
State/Province
Gauteng
ZIP/Postal Code
181
Country
South Africa
Facility Name
Durban International Clinical Research Site (Site 9208), Sidmouth Avenue
City
Durban
State/Province
Kwazulu - Natal
ZIP/Postal Code
4052
Country
South Africa
Facility Name
Welkom Clinical Trial Centre (Site 9211), 189 Power Road
City
Welkom
State/Province
Matjhabeng, Free State
ZIP/Postal Code
9459
Country
South Africa
Facility Name
The Aurum Institute Klerksdorp Clinical Research Center (Site 9204), Corner Margaretha Prinsloo St. and O.R. Tambo St.
City
Klerksdorp
State/Province
North-West
ZIP/Postal Code
2571
Country
South Africa
Facility Name
The Aurum Institute Rustenburg Clinical Research Site (Site 9202), 50 Steen St., c/o Pretorius St.
City
Rustenburg
State/Province
North-West
ZIP/Postal Code
300
Country
South Africa
Facility Name
TASK Eden (Site 9218), G, 4 Victoria St.
City
George
ZIP/Postal Code
6530
Country
South Africa
Facility Name
CLINRESCO, ARWYP Medical Suites (Site 9209), 22 Pine Avenue
City
Johannesburg
ZIP/Postal Code
1619
Country
South Africa
Facility Name
Mzansi Ethical Research Centre (Site 9212), 184 Cowen Ntuli Street, Steve Tschwete
City
Mpumalanga
ZIP/Postal Code
1055
Country
South Africa
Facility Name
Global Clinical Trials Sunnyside (Site 9216), 175 Steve Biko Street
City
Pretoria
ZIP/Postal Code
2000
Country
South Africa
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
36289399
Citation
Choudhary MC, Chew KW, Deo R, Flynn JP, Regan J, Crain CR, Moser C, Hughes MD, Ritz J, Ribeiro RM, Ke R, Dragavon JA, Javan AC, Nirula A, Klekotka P, Greninger AL, Fletcher CV, Daar ES, Wohl DA, Eron JJ, Currier JS, Parikh UM, Sieg SF, Perelson AS, Coombs RW, Smith DM, Li JZ; ACTIV-2/A5401 Study Team. Emergence of SARS-CoV-2 escape mutations during Bamlanivimab therapy in a phase II randomized clinical trial. Nat Microbiol. 2022 Nov;7(11):1906-1917. doi: 10.1038/s41564-022-01254-1. Epub 2022 Oct 26.
Results Reference
derived
PubMed Identifier
35793677
Citation
Boucau J, Chew KW, Choudhary MC, Deo R, Regan J, Flynn JP, Crain CR, Hughes MD, Ritz J, Moser C, Dragavon JA, Javan AC, Nirula A, Klekotka P, Greninger AL, Coombs RW, Fischer WA 2nd, Daar ES, Wohl DA, Eron JJ, Currier JS, Smith DM; POSITIVES study team; Li JZ, Barczak AK; ACTIV-2/A5401 Study Team. Monoclonal antibody treatment drives rapid culture conversion in SARS-CoV-2 infection. Cell Rep Med. 2022 Jul 19;3(7):100678. doi: 10.1016/j.xcrm.2022.100678. Epub 2022 Jun 20.
Results Reference
derived
PubMed Identifier
35713300
Citation
Hirsch C, Park YS, Piechotta V, Chai KL, Estcourt LJ, Monsef I, Salomon S, Wood EM, So-Osman C, McQuilten Z, Spinner CD, Malin JJ, Stegemann M, Skoetz N, Kreuzberger N. SARS-CoV-2-neutralising monoclonal antibodies to prevent COVID-19. Cochrane Database Syst Rev. 2022 Jun 17;6(6):CD014945. doi: 10.1002/14651858.CD014945.pub2.
Results Reference
derived
PubMed Identifier
34981077
Citation
Chew KW, Moser C, Daar ES, Wohl DA, Li JZ, Coombs R, Ritz J, Giganti M, Javan AC, Li Y, Malvestutto C, Klekotka P, Price K, Nirula A, Fischer W, Bala V, Ribeiro RM, Perelson AS, Fletcher CV, Eron JJ, Currier JS, Hughes MD, Smith DM; ACTIV-2/A5401 Study Team. Bamlanivimab reduces nasopharyngeal SARS-CoV-2 RNA levels but not symptom duration in non-hospitalized adults with COVID-19: A Phase 2 Randomized Clinical Trial. medRxiv. 2021 Dec 21:2021.12.17.21268009. doi: 10.1101/2021.12.17.21268009. Preprint.
Results Reference
derived
PubMed Identifier
34473343
Citation
Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
Results Reference
derived
Links:
URL
http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls
URL
https://www.cdc.gov/coronavirus/2019-nCoV/index.html
Description
CDC (Centers for Disease Control and Prevention): Coronavirus (COVID-19) website
URL
https://www.niaid.nih.gov/clinical-trials/participant-guide
Description
A Participant's Guide to Clinical Trials (NIAID)
URL
https://www.niaid.nih.gov/clinical-trials/find-a-clinical-trial
Description
Find a Clinical Trial (NIAID)
URL
https://www.niaid.nih.gov/clinical-trials
Description
Clinical Trials at NIAID
URL
https://www.niaid.nih.gov/
Description
National Institute for Allergy and Infectious Diseases (NIAID)
URL
https://www.covid19treatmentguidelines.nih.gov/
Description
NIH COVID-19 treatment guidelines
URL
https://www.who.int/emergencies/diseases/novel-coronavirus-2019/
Description
WHO COVID-19 treatment guidelines
URL
https://www.nih.gov/research-training/medical-research-initiatives/activ
Description
NIH: Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV)
Learn more about this trial
ACTIV-2: A Study for Outpatients With COVID-19
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