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ACTIV-3: Therapeutics for Inpatients With COVID-19 (TICO)

Primary Purpose

Covid19

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
LY3819253
Placebo
Remdesivir
VIR-7831
BRII-196/BRII-198
AZD7442
MP0420
PF-07304814
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19 focused on measuring COVID-19, COVID 19, Coronaviridae Infections, Coronavirus Infections, RNA Virus Infections, Virus Diseases, Nidovirales Infections, SARS-CoV-2, SARS Coronavirus, ACTIV-3, ACTIV3

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Signed informed consent.
  • Positive test for COVID-19 and progressive disease suggestive of ongoing COVID-19 infection.
  • Symptoms of COVID-19 for ≤ 12 days.
  • Require admission to hospital for acute medical care (not for purely public health or quarantine purposes).

Exclusion Criteria:

  • Patients who have received plasma from a person who recovered from COVID-19 or who have received neutralizing monoclonal antibodies at any time prior to hospitalization.
  • Patients not willing to abstain from participation in other COVID-19 treatment trials until after Day 5 of the study. Co-enrollment in certain trials that compare recommended Standard of Care treatments may be allowed, based on the opinion of the study leadership team.
  • Any condition which, in the opinion of the responsible investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments.
  • Patients considered unable to participate in study procedures.
  • Women of child-bearing potential who are not already pregnant at study entry and who are unwilling to acknowledge strong advice to abstain from sexual intercourse with men or practice appropriate contraception through 18 months of the study.
  • Women of child-bearing potential who are unwilling to acknowledge the strong advice to abstain from sexual intercourse with men or practice appropriate contraception through 5 weeks of the study (PF-07304814 investigational agent).
  • Pregnant women (PF-07304814 investigational agents).
  • Nursing mothers (PF-07304814 investigational agents).
  • Men who are unwilling to acknowledge the strong advice to abstain from sexual intercourse with women of child-bearing potential or to use barrier contraception through 18 months of the study.
  • Men who are unwilling to acknowledge the strong advice to abstain from sexual intercourse with women of child-bearing potential or to use barrier contraception through 5 weeks of the study (PF-07304814 investigational agent).

  • Presence at study enrollment of any of the following:

    1. stroke
    2. meningitis
    3. encephalitis
    4. myelitis
    5. myocardial ischemia
    6. myocarditis
    7. pericarditis
    8. symptomatic congestive heart failure
    9. arterial or deep venous thrombosis or pulmonary embolism

  • Current or imminent requirement for any of the following:

    1. invasive mechanical ventilation
    2. ECMO (extracorporeal membrane oxygenation)
    3. Mechanical circulatory support
    4. vasopressor therapy
    5. commencement of renal replacement therapy at this admission (i.e. not patients on chronic renal replacement therapy).
  • Participants with moderate to severe hepatic impairment (i.e. Child-Pugh class B or C) or acute liver failure (PF-07304814 investigational agent).
  • Participants receiving any medications or substances that are strong inhibitors or inducers of cytochrome P450 (CYP) 3A4 (PF-07304814 investigational agent).
  • Patients will be excluded if taking drugs which have a narrow therapeutic window that are substrates of CYP3A4, including but not limited to: astemizole, cisapride, cyclosporine, dihydroergotamine, ergotamine, pimozide, quinidine, sirolimus, tacrolimus, and terfenadine (PF-07304814 investigational agent).
  • Patients with a history of deep vein thrombosis or pulmonary thrombotic embolism (Prior to initial futility assessment of PF-07304814 investigational agent).

Sites / Locations

  • Banner University Medical Center Tucson (Site 206-004), 1625 N. Campbell Avenue
  • Southern Arizona VA Healthcare System (Site 074-009), 3601 S. 6th Ave.
  • Velocity Chula Vista (Site 080-034), 752 Medical Center Ct., Ste. 304
  • Community Regional Medical Center (Site 203-005), 2823 Fresno Street
  • Velocity San Diego (Site 080-035), 5565 Grossmont Center Drive, Building 2, Suite 1
  • VA Loma Linda Healthcare System (Site 074-017), 11201 Benton Street
  • VA Long Beach Healthcare System (Site 074-026), 5901 East 7th Street (09/151-M2)
  • Keck Hospital of USC (Site 301-020), 1500 San Pablo Street
  • Cedars-Sinai Medical Center (Site 208-002), 8700 Beverly Blvd.
  • Ronald Reagan UCLA Medical Center (Site 203-002), 757 Westwood Plaza
  • Sacramento VA Medical Center (Site 074-023), 10535 Hospital Way
  • Hoag Memorial Hospital Presbyterian (Site 080-026), One Hoag Drive
  • Palo Alto VAMC (Site 074-005), 3801 Miranda Avenue
  • UC Davis Health (Site 203-004), 2315 Stockton Blvd.
  • VA San Diego Healthcare System (Site 074-016), 3350 La Jolla Village Drive
  • UCSF Medical Center at Mount Zion (Site 203-007), 1600 Divisadero St.
  • San Francisco VAMC (Site 074-002), 4150 Clement St.
  • UCSF Medical Center (Site 203-001), Moffitt-Long Hospital, 505 Parnassus Ave.
  • Stanford University Hospital & Clinics (Site 203-003), 300 Pasteur Dr.
  • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center (Site 066-002), 1124 W. Carson Street, CDCRC Building
  • University of Colorado Hospital (Site 204-001), 12605 E. 16th Avenue
  • Denver Public Health (Site 017-004), 660 Bannock St., MC2600 (Infectious Disease Clinic)
  • National Jewish Health / St. Joseph Hospital (Site 204-003), 1400 Jackson Street
  • West Haven VA Medical Center (Site 025-007), 950 Campbell Avenue
  • MedStar Georgetown University Hospital (Site 067-001), 3800 Reservoir Road NW
  • MedStar Health Research Institute (Site 009-021), MedStar Washington Hospital Center, 110 Irving St., NW.
  • Washington DC VA Medical Center (Site 009-004), 50 Irving Street NW
  • Bay Pines VAMC (Site 074-004), 10000 Bay Pines Blvd., Bldg. 100, Room 5B-104
  • Baycare Health System (Site 301-025), Morton Plant Hospital, 300 Pinellas Street
  • North Florida/South Georgia Veterans Health System (Site 074-011), 1601 SW. Archer Road
  • Memorial Healthcare System (Site 648-002), Memorial Regional Hospital, 3501 Johnson Street
  • Miami VAMC (Site 074-003), 1201 NW 16 Street
  • Hillsborough County Health Department, University of South Florida (Site 032-001)
  • Emory University (Site 301-008), The Emory Clinic, Bldg. A, Suite 2236, 1365 Clifton Rd., NE
  • Lutheran Medical Group (Site 301-010), 7916 W. Jefferson Boulevard
  • Cotton O'Neil Clinical Research Center (Site 080-030), Stormont Vail Health, 1500 SW 10th Avenue
  • University of Kentucky Hospital (Site 210-004), 1000 South Limestone St.
  • Ochsner Clinic Foundation (Site 301-015), 1514 Jefferson Highway
  • University of Maryland Medical Center (Site 301-019), 22 South Greene Street
  • Massachusetts General Hospital (Site 202-002), 55 Fruit Street
  • Beth Israel Deaconess Medical Center (Site 202-001), 330 Brookline Ave.
  • Baystate Medical Center (Site 201-001), 759 Chestnut Street
  • University of Michigan (Site 205-001), 1500 East Medical Center Drive
  • Henry Ford Health System, Henry Ford Hospital (Site 014-001), 2799 W. Grand Blvd.
  • Minneapolis Heart Institute Foundation (Site 301-026), Abbott Northwestern Hospital, 920 E 28th St. #100
  • Hennepin Healthcare (Site 027-001), 701 Park Avenue
  • Minneapolis VA Health Care System (Site 105-001), 1 Veterans Drive, Bldg 70
  • M Health Fairview University of Minnesota Medical Center (Site 112-001), 500 Harvard St. SE.
  • University of Mississippi Medical Center (Site 202-005), 2500 North State Street
  • VA St. Louis Healthcare System (Site 074-027), 915 North Grand Blvd., Rm. C201
  • Dartmouth-Hitchcock Medical Center/Mary Hitchcock Memorial Hospital (Site 301-024), One Medical Center Drive
  • Cooper University Hospital (Site 019-001), One Cooper Plaza
  • Lincoln Medical Center (New York Health and Hospitals/Lincoln) (Site 003-016), 234 E. 149th Street
  • Montefiore Medical Center Weiler Hospital (Site 206-003), 1825 Eastchester Road
  • Montefiore Medical Center Moses Hospital (Site 206-001), 111 E. 210th Street
  • SUNY Downstate Medical Center (Site 033-001), 450 Clarkson Ave.
  • Maimonides Medical Center (Site 033-002), 4802 10th Avenue
  • Ichan School of Medicine at Mount Sinai (Site 301-012), One Gustave L. Levy Place, Box 1620
  • Duke University Hospital (Site 301-006), 2301 Erwin Road
  • Wake Forest University Health Sciences (Site 210-001), Medical Center Blvd
  • University of Cincinnati Medical Center (Site 207-003), 234 Goodman Ave.
  • University Hospitals Cleveland Medical Center (Site 108-001), 11100 Euclid Avenue
  • Cleveland Clinic Fairview Hospital (Site 207-005), 18101 Lorain Avenue
  • Cleveland Clinic Foundation (Site 207-001), 9500 Euclid Avenue
  • Cleveland Clinic Marymount Hospital (Site 207-006), 12300 McCraken Road
  • Oregon Health & Science University (Site 208-003), 3181 SW Sam Jackson Park Rd.
  • Portland VA Healthcare System (Site 074-024), 3710 SW. US Veterans Hospital Road
  • UPMC Magee-Womens Hospital (Site 209-003), 300 Halket Street
  • UPMC Presbyterian Hospital (Site 209-001), 200 Lothrop Street
  • UPMC Shadyside Hospital (Site 209-005), 5230 Centre Avenue
  • Rhode Island Hospital (Site 080-036), 593 Eddy Street
  • The Miriam Hospital (Site 080-039), 164 Summit Ave.
  • VA Providence Healthcare System (Site 074-025), 830 Chalkstone Ave.
  • Ralph H. Johnson VA Medical Center (Site 074-015), 109 Bee Street
  • MUSC Research Nexus Clinic (Site 210-002), 96 Jonathan Lucas St., CSB 214
  • MUSC Health Florence Medical Center (Site 210-006), 805 Pamplico Highway
  • VA TVHS Nashville Campus (Site 074-022), 1310 24th Avenue South
  • Vanderbilt University Medical Center (Site 212-001), 1211 Medical Center Drive
  • Hendrick Medical Center (Site 080-014), 1900 Pine Street
  • CHRISTUS Spohn Shoreline Hospital (Site 080-001), 600 Elizabeth Street
  • Parkland Health and Hospital Systems (Site 084-002), 5200 Harry Hines Blvd
  • UT Southwestern Medical Center (Site 084-001), 1936 Amelia Court, 2nd Floor
  • Baylor, Scott and White Health (Site 301-003), Baylor University Medical Center, 3500 Gaston Ave.
  • Memorial Hermann Hospital (Site 203-006), 6411 Fannin Street
  • Michael E. DeBakey Veterans Affairs Medical Center (MEDV AMC) (Site 074-006), 2002 Holcombe Blvd.
  • Texas Heart Institute (Site 301-017), 6770 Bertner, MC4-266
  • CHRISTUS Good Shepherd Medical Center (Site 080-031), 700 E. Marshall Ave.
  • Intermountain Medical Center (Site 211-001), 5121 South Cottonwood Street
  • University of Utah Hospital (Site 211-002), 419 Wakara Way, Suite 207
  • LDS Hospital (Site 211-004), 8th Ave. C Street
  • University of Virginia Health Systems (Site 301-021), 1215 Lee Street
  • Virginia Commonwealth University Health System (Site 210-005), 1250 East Marshall Street
  • Carilion Roanoke Memorial Hospital (Site 080-018), 1906 Belleview Avenue
  • Salem VA Medical Center (Site 074-014), 1970 Roanoke Blvd.
  • Harborview Medical Center (Site 208-001), 325 9th Avenue
  • Swedish Hospital First Hill (Site 208-005), 747 Broadway
  • University of Washington Medical Center - Montlake (Site 208-006), 1959 NE Pacific Street
  • West Virginia University (Site 301-023), One Medical Center Drive
  • Aalborg Hospital (Site 625-005), Hobrovej 18
  • Aarhus Universitetshospital, Skejby (Site 625-002), Department of Infectious Diseases, Palle Juul-Hensens Boulevard 99
  • Righospitalet (Site 625-006), Blegdamsvej 9,
  • Bispebjerg Hospital (Site 625-013), Bispebjerg Bakke 23
  • Herlev/Gentofte Hospital (Site 625-012), Medicinsk Afdeling, Herlev Ringvej 75
  • Nordsjællands Hospital (Site 625-009), Dyrehavevej 29
  • Hvidovre University Hospital, Department of Infectious Diseases (Site 625-001), Kettegård allé 30
  • Kolding Sygehus (Site 625-011), Medicinsk Afdeling, Sygehusvej 24
  • Odense University Hospital (Site 625-004), Infektionsmedicinsk Forskningsenhed, J.B. Winsløwsgade 4
  • Zealand University Hospital, Roskilde (Site 625-010), Sygehusvej 10
  • Democritus University of Thrace (Site 635-021), University General Hospital of Alexandroupolis, Dragana
  • Evangelismos COVID-19 Unit, (Site 635-020), 1st Dept. of Pulmonary and Critical Care Medicine, Evangelismos General Hospital, Dept., Ipsilantou 45-47
  • 1st Respiratory Medicine Dept., Athens University Medical School (Site 635-015), Athens Hospital for Diseases of the Chest "Sotiria Hospital", 152 Mesogeion Ave.
  • 3rd Dept. of Medicine, Medical School, NKUA (Site 635-022), Sotiria General Hospital, 152 Mesogeion Ave.
  • Attikon University General Hospital (Site 635-009), 4th Dept. of Internal Medicine, Medical School, National and Kapodistrian University of Athens, 1 Rimini St., Haidari
  • Institute of Human Virology Nigeria (IHVN) (Site 612-601), Plot 252, Herbert Macaulay Way, Central Business District
  • Wojewódzki Szpital Zakazny (Site 625-302), Wolska 37
  • Tan Tock Seng Hospital (Site 612-201), National Centre for Infectious Diseases (NCID), 11 Jalan Tan Tock Seng
  • Hospital Universitari Germans Trias i Pujol (Site 626-003), Infectious Disease Unit, Second Floor, Building Maternal, Road Canyet s/n
  • Hospital Universitari Arnau de Vilanova (Site 626-035), Av. Alcalde Rovira Roure 80
  • Hospital Del Mar (Site 626-025), Paseo Maritimo 25-29
  • Hospital Universitari Vall d'Hebron (Site 626-033), Passeig de la Vall d'Hebron 119-129
  • Hospital Clínic de Barcelona (Site 626-004), Carrer de Villaroel 170
  • Hospital Universitario de Bellvitge (Site 626-034), Carrer de la Feixa Llarga, s/n
  • Hospital General Universitario Gregorio Marañón (Site 626-001), Dr. Esquerdo, 46
  • Hospital Clínico San Carlos (Site 626-017), Enfermedades infecciosas, C/Martin Lagos CN
  • UCICEC (Clinical Trial Unit) Hospital Universitario La Paz (Site 626-012), Paseo de la Castellana 261, 2a planta Hospital Maternal
  • University Hospital Zurich (Site 621-201), Department of Infectious Diseases and Hospital Epidemiology, Raemistrasse 100
  • MRC/UVRI and LSHTM Uganda Research Unit (Site 634-601), Entebbe Regional Referral Hospital
  • Gulu Regional Referral Hospital (Site 634-603), Laroo Division, PO Box 160
  • Makerere University Lung Institute (Site 634-604), New Mulago Hospital Complex, Mulago Hill
  • St. Francis Hospital, Nsambya (Site 634-607), Nsambya Road Nsambya Hill, P.O. Box 7146
  • Lira Regional Referral Hospital (Site 634-605)
  • Masaka Regional Referral Hospital (Site 634-606), MRC/UVRI and LSHTM Uganda Research Unit, Plot 6 Circle Road, PO Box 556
  • Royal Victoria Infirmary (Site 634-007), Queen Victoria Road
  • Royal Free Hospital (Site 634-006), Pond Street, Hampstead
  • Guy's and St. Thomas' NHS Foundation Trust (Site 634-011)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ACTIV-3 Drug plus SOC

Placebo plus SOC

Arm Description

Participants in this study will be randomized to receive one of the ACTIV-3 drug treatments plus Standard of Care (SOC) or placebo plus SOC

The placebo arm may be pooled across more than one experimental arm if multiple investigational drugs are available to be tested at the same time. If it is not possible to use matching placebo over more than one experimental arm, additional placebo arms will be included in the study

Outcomes

Primary Outcome Measures

Time from randomization to sustained recovery
Sustained recovery defined as being discharged from the index hospitalization, followed by being alive and home for 14 consecutive days prior to Day 90.

Secondary Outcome Measures

All-cause mortality
Composite of time to sustained recovery and mortality
Days alive outside short-term acute care hospital
Pulmonary ordinal outcome
Oxygen requirements measured by 7 categories (1 = least severe, 7 = most severe). The participant's highest (i.e. most severe) observed score is used.
Pulmonary+ ordinal outcome
Extrapulmonary complications and respiratory dysfunction measured by 7 categories (1= least severe, 7 = most severe). The participant's highest (i.e. most severe) observed score is used.
Incidence of clinical organ failure
Composite of death or serious clinical COVID-19 related events
Composite of cardiovascular events and thromboembolic events
Composite of grade 3 and 4 clinical adverse events, serious adverse events (SAEs) or death
Incidence of infusion reactions
Composite of SAEs or death
Change in SARS-CoV-2 neutralizing antibody levels
Change in overall titers of antibodies
Change in neutralizing antibody levels
Incidence of home use of supplemental oxygen above pre-morbid oxygen use
Measured as: Alive at home and no use of continuous supplemental oxygen for an uninterrupted 14 day period
Incidence of no home use of supplemental oxygen above pre-morbid oxygen use
Measured as: Alive at home for an uninterrupted 14 day period and no use of continuous supplemental oxygen at end of 14 day time period.

Full Information

First Posted
August 3, 2020
Last Updated
August 23, 2023
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
International Network for Strategic Initiatives in Global HIV Trials (INSIGHT), University of Copenhagen, Medical Research Council, Kirby Institute, Washington D.C. Veterans Affairs Medical Center, AIDS Clinical Trials Group, National Heart, Lung, and Blood Institute (NHLBI), US Department of Veterans Affairs, Prevention and Early Treatment of Acute Lung Injury, Cardiothoracic Surgical Trials Network, Eli Lilly and Company, Vir Biotechnology, Inc., GlaxoSmithKline, Brii Biosciences Limited, AstraZeneca, Molecular Partners AG, Pfizer, University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT04501978
Brief Title
ACTIV-3: Therapeutics for Inpatients With COVID-19
Acronym
TICO
Official Title
A Multicenter, Adaptive, Randomized, Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for Hospitalized Patients With COVID-19
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
August 4, 2020 (Actual)
Primary Completion Date
April 6, 2022 (Actual)
Study Completion Date
July 14, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
International Network for Strategic Initiatives in Global HIV Trials (INSIGHT), University of Copenhagen, Medical Research Council, Kirby Institute, Washington D.C. Veterans Affairs Medical Center, AIDS Clinical Trials Group, National Heart, Lung, and Blood Institute (NHLBI), US Department of Veterans Affairs, Prevention and Early Treatment of Acute Lung Injury, Cardiothoracic Surgical Trials Network, Eli Lilly and Company, Vir Biotechnology, Inc., GlaxoSmithKline, Brii Biosciences Limited, AstraZeneca, Molecular Partners AG, Pfizer, University of Minnesota

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
This study looks at the safety and effectiveness of different drugs in treating COVID-19 in people who have been hospitalized with the infection. Participants in the study will be treated with either a study drug plus current standard of care (SOC), or with placebo plus current SOC.
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 protocol is for a randomized, blinded, controlled platform study that allows investigational drugs to be added and dropped during the course of the study. This allows for efficient testing of new drugs against placebo and standard of care (SOC) treatment within the same study. When more than one drug is being tested at the same time, participants will be randomly allocated to treatments or placebo. Randomization will be stratified by study site pharmacy and disease severity. There are 2 disease severity strata: Participants without organ failure (severity stratum 1); and participants with organ failure (severity stratum 2). An independent Data and Safety Monitoring Board (DSMB) will regularly review interim analyses and summarize safety and efficacy outcomes. For investigational drugs with minimal pre-existing safety knowledge, the pace of enrollment with be initially restricted, and there will be an early review of safety data by the DSMB. For the study of each agent, at the outset of the trial, only participants in disease severity stratum 1 will be enrolled. This will continue until approximately 300 participants are enrolled and followed for 5 days. The exact number will vary according to the speed of enrollment and the timing of DSMB meetings. Prior to expanding enrollment to also include patients in disease severity stratum 2, safety will be evaluated and a pre-specified futility assessment by the DSMB will be carried out using 2 ordinal outcomes assessed at Day 5. Both ordinal outcomes are used to assess futility because it is currently unclear whether the investigational agents under study will primarily influence non-pulmonary outcomes, for which risk is increased with SARS-CoV-2 infection, in part, through mechanisms that may be different from those that influence pulmonary outcomes. For investigational agents passing this futility assessment, enrollment of participants will be expanded, seamlessly and without any data unblinding, to include participants in disease severity stratum 2 as well as those in disease severity stratum 1. Future interim analyses will be based on the primary endpoint of sustained recovery and will use pre-specified guidelines to determine early evidence of benefit, harm or futility for the investigational agent. Participants will be followed for 18 months following randomization. The international trials within this protocol will be conducted in several hundred clinical sites. Participating sites are affiliated with networks funded by the United States National Institutes of Health (NIH) and the US Department of Veterans Affairs.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
COVID-19, COVID 19, Coronaviridae Infections, Coronavirus Infections, RNA Virus Infections, Virus Diseases, Nidovirales Infections, SARS-CoV-2, SARS Coronavirus, ACTIV-3, ACTIV3

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
2753 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ACTIV-3 Drug plus SOC
Arm Type
Experimental
Arm Description
Participants in this study will be randomized to receive one of the ACTIV-3 drug treatments plus Standard of Care (SOC) or placebo plus SOC
Arm Title
Placebo plus SOC
Arm Type
Placebo Comparator
Arm Description
The placebo arm may be pooled across more than one experimental arm if multiple investigational drugs are available to be tested at the same time. If it is not possible to use matching placebo over more than one experimental arm, additional placebo arms will be included in the study
Intervention Type
Biological
Intervention Name(s)
LY3819253
Intervention Description
Participants are no longer being randomized to this intervention.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Commercially available 0.9% sodium chloride solution. Administered by IV infusion
Intervention Type
Biological
Intervention Name(s)
Remdesivir
Intervention Description
Provided to all study participants as SOC unless contraindicated for an individual patient.
Intervention Type
Biological
Intervention Name(s)
VIR-7831
Intervention Description
Participants are no longer being randomized to this intervention.
Intervention Type
Biological
Intervention Name(s)
BRII-196/BRII-198
Intervention Description
Participants are no longer being randomized to this intervention.
Intervention Type
Biological
Intervention Name(s)
AZD7442
Other Intervention Name(s)
AZD8895 + AZD1061
Intervention Description
Participants are no longer being randomized to this intervention.
Intervention Type
Drug
Intervention Name(s)
MP0420
Other Intervention Name(s)
ensovibep
Intervention Description
Participants are no longer being randomized to this intervention.
Intervention Type
Drug
Intervention Name(s)
PF-07304814
Intervention Description
250 mg per day for 5 days. Administered as a constant rate intravenous infusion. Suspended: Participants are not currently being randomized to this intervention.
Primary Outcome Measure Information:
Title
Time from randomization to sustained recovery
Description
Sustained recovery defined as being discharged from the index hospitalization, followed by being alive and home for 14 consecutive days prior to Day 90.
Time Frame
Up to Day 90
Secondary Outcome Measure Information:
Title
All-cause mortality
Time Frame
Thru Day 90
Title
Composite of time to sustained recovery and mortality
Time Frame
Thru Day 90
Title
Days alive outside short-term acute care hospital
Time Frame
Up to Day 90
Title
Pulmonary ordinal outcome
Description
Oxygen requirements measured by 7 categories (1 = least severe, 7 = most severe). The participant's highest (i.e. most severe) observed score is used.
Time Frame
Days 1-7, 14 and 28
Title
Pulmonary+ ordinal outcome
Description
Extrapulmonary complications and respiratory dysfunction measured by 7 categories (1= least severe, 7 = most severe). The participant's highest (i.e. most severe) observed score is used.
Time Frame
Days 1-7
Title
Incidence of clinical organ failure
Time Frame
Thru Day 28
Title
Composite of death or serious clinical COVID-19 related events
Time Frame
Thru Day 90
Title
Composite of cardiovascular events and thromboembolic events
Time Frame
Thru Day 90
Title
Composite of grade 3 and 4 clinical adverse events, serious adverse events (SAEs) or death
Time Frame
Thru Days 5 and 28
Title
Incidence of infusion reactions
Time Frame
Thru Day 0
Title
Composite of SAEs or death
Time Frame
Thru 18 months
Title
Change in SARS-CoV-2 neutralizing antibody levels
Time Frame
Baseline to Days 1, 3, 5, 28 and 90
Title
Change in overall titers of antibodies
Time Frame
Baseline to Days 1, 3, 5, 28 and 90
Title
Change in neutralizing antibody levels
Time Frame
Baseline to Days 1, 3, 5, 28 and 90
Title
Incidence of home use of supplemental oxygen above pre-morbid oxygen use
Description
Measured as: Alive at home and no use of continuous supplemental oxygen for an uninterrupted 14 day period
Time Frame
18 months
Title
Incidence of no home use of supplemental oxygen above pre-morbid oxygen use
Description
Measured as: Alive at home for an uninterrupted 14 day period and no use of continuous supplemental oxygen at end of 14 day time period.
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed informed consent. Positive test for COVID-19 and progressive disease suggestive of ongoing COVID-19 infection. Symptoms of COVID-19 for ≤ 12 days. Require admission to hospital for acute medical care (not for purely public health or quarantine purposes). Exclusion Criteria: Patients who have received plasma from a person who recovered from COVID-19 or who have received neutralizing monoclonal antibodies at any time prior to hospitalization. Patients not willing to abstain from participation in other COVID-19 treatment trials until after Day 5 of the study. Co-enrollment in certain trials that compare recommended Standard of Care treatments may be allowed, based on the opinion of the study leadership team. Any condition which, in the opinion of the responsible investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments. Patients considered unable to participate in study procedures. Women of child-bearing potential who are not already pregnant at study entry and who are unwilling to acknowledge strong advice to abstain from sexual intercourse with men or practice appropriate contraception through 18 months of the study. Women of child-bearing potential who are unwilling to acknowledge the strong advice to abstain from sexual intercourse with men or practice appropriate contraception through 5 weeks of the study (PF-07304814 investigational agent). Pregnant women (PF-07304814 investigational agents). Nursing mothers (PF-07304814 investigational agents). Men who are unwilling to acknowledge the strong advice to abstain from sexual intercourse with women of child-bearing potential or to use barrier contraception through 18 months of the study. Men who are unwilling to acknowledge the strong advice to abstain from sexual intercourse with women of child-bearing potential or to use barrier contraception through 5 weeks of the study (PF-07304814 investigational agent). Presence at study enrollment of any of the following: stroke meningitis encephalitis myelitis myocardial ischemia myocarditis pericarditis symptomatic congestive heart failure arterial or deep venous thrombosis or pulmonary embolism Current or imminent requirement for any of the following: invasive mechanical ventilation ECMO (extracorporeal membrane oxygenation) Mechanical circulatory support vasopressor therapy commencement of renal replacement therapy at this admission (i.e. not patients on chronic renal replacement therapy). Participants with moderate to severe hepatic impairment (i.e. Child-Pugh class B or C) or acute liver failure (PF-07304814 investigational agent). Participants receiving any medications or substances that are strong inhibitors or inducers of cytochrome P450 (CYP) 3A4 (PF-07304814 investigational agent). Patients will be excluded if taking drugs which have a narrow therapeutic window that are substrates of CYP3A4, including but not limited to: astemizole, cisapride, cyclosporine, dihydroergotamine, ergotamine, pimozide, quinidine, sirolimus, tacrolimus, and terfenadine (PF-07304814 investigational agent). Patients with a history of deep vein thrombosis or pulmonary thrombotic embolism (Prior to initial futility assessment of PF-07304814 investigational agent).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prof. Jens Lundgren
Organizational Affiliation
INSIGHT Copenhagen International Coordinating Centre, Rigshospitalet, University of Copenhagen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Prof. James Neaton
Organizational Affiliation
INSIGHT Statistical and Coordinating Centre, University of Minnesota
Official's Role
Study Chair
Facility Information:
Facility Name
Banner University Medical Center Tucson (Site 206-004), 1625 N. Campbell Avenue
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
Country
United States
Facility Name
Southern Arizona VA Healthcare System (Site 074-009), 3601 S. 6th Ave.
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85723
Country
United States
Facility Name
Velocity Chula Vista (Site 080-034), 752 Medical Center Ct., Ste. 304
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States
Facility Name
Community Regional Medical Center (Site 203-005), 2823 Fresno Street
City
Fresno
State/Province
California
ZIP/Postal Code
93701
Country
United States
Facility Name
Velocity San Diego (Site 080-035), 5565 Grossmont Center Drive, Building 2, Suite 1
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
VA Loma Linda Healthcare System (Site 074-017), 11201 Benton Street
City
Loma Linda
State/Province
California
ZIP/Postal Code
92357
Country
United States
Facility Name
VA Long Beach Healthcare System (Site 074-026), 5901 East 7th Street (09/151-M2)
City
Long Beach
State/Province
California
ZIP/Postal Code
90822
Country
United States
Facility Name
Keck Hospital of USC (Site 301-020), 1500 San Pablo Street
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Cedars-Sinai Medical Center (Site 208-002), 8700 Beverly Blvd.
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Ronald Reagan UCLA Medical Center (Site 203-002), 757 Westwood Plaza
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Sacramento VA Medical Center (Site 074-023), 10535 Hospital Way
City
Mather
State/Province
California
ZIP/Postal Code
95655
Country
United States
Facility Name
Hoag Memorial Hospital Presbyterian (Site 080-026), One Hoag Drive
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Palo Alto VAMC (Site 074-005), 3801 Miranda Avenue
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
UC Davis Health (Site 203-004), 2315 Stockton Blvd.
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
VA San Diego Healthcare System (Site 074-016), 3350 La Jolla Village Drive
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States
Facility Name
UCSF Medical Center at Mount Zion (Site 203-007), 1600 Divisadero St.
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
San Francisco VAMC (Site 074-002), 4150 Clement St.
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States
Facility Name
UCSF Medical Center (Site 203-001), Moffitt-Long Hospital, 505 Parnassus Ave.
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Stanford University Hospital & Clinics (Site 203-003), 300 Pasteur Dr.
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center (Site 066-002), 1124 W. Carson Street, CDCRC Building
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
University of Colorado Hospital (Site 204-001), 12605 E. 16th Avenue
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Denver Public Health (Site 017-004), 660 Bannock St., MC2600 (Infectious Disease Clinic)
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
Facility Name
National Jewish Health / St. Joseph Hospital (Site 204-003), 1400 Jackson Street
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
Facility Name
West Haven VA Medical Center (Site 025-007), 950 Campbell Avenue
City
West Haven
State/Province
Connecticut
ZIP/Postal Code
06516
Country
United States
Facility Name
MedStar Georgetown University Hospital (Site 067-001), 3800 Reservoir Road NW
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
MedStar Health Research Institute (Site 009-021), MedStar Washington Hospital Center, 110 Irving St., NW.
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Washington DC VA Medical Center (Site 009-004), 50 Irving Street NW
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20422
Country
United States
Facility Name
Bay Pines VAMC (Site 074-004), 10000 Bay Pines Blvd., Bldg. 100, Room 5B-104
City
Bay Pines
State/Province
Florida
ZIP/Postal Code
33744
Country
United States
Facility Name
Baycare Health System (Site 301-025), Morton Plant Hospital, 300 Pinellas Street
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
North Florida/South Georgia Veterans Health System (Site 074-011), 1601 SW. Archer Road
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608-1197
Country
United States
Facility Name
Memorial Healthcare System (Site 648-002), Memorial Regional Hospital, 3501 Johnson Street
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Miami VAMC (Site 074-003), 1201 NW 16 Street
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
Hillsborough County Health Department, University of South Florida (Site 032-001)
City
Tampa
State/Province
Florida
ZIP/Postal Code
33602
Country
United States
Facility Name
Emory University (Site 301-008), The Emory Clinic, Bldg. A, Suite 2236, 1365 Clifton Rd., NE
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Lutheran Medical Group (Site 301-010), 7916 W. Jefferson Boulevard
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
Facility Name
Cotton O'Neil Clinical Research Center (Site 080-030), Stormont Vail Health, 1500 SW 10th Avenue
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66604
Country
United States
Facility Name
University of Kentucky Hospital (Site 210-004), 1000 South Limestone St.
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Ochsner Clinic Foundation (Site 301-015), 1514 Jefferson Highway
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
University of Maryland Medical Center (Site 301-019), 22 South Greene Street
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Massachusetts General Hospital (Site 202-002), 55 Fruit Street
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Beth Israel Deaconess Medical Center (Site 202-001), 330 Brookline Ave.
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Baystate Medical Center (Site 201-001), 759 Chestnut Street
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States
Facility Name
University of Michigan (Site 205-001), 1500 East Medical Center Drive
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Henry Ford Health System, Henry Ford Hospital (Site 014-001), 2799 W. Grand Blvd.
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Minneapolis Heart Institute Foundation (Site 301-026), Abbott Northwestern Hospital, 920 E 28th St. #100
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Hennepin Healthcare (Site 027-001), 701 Park Avenue
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States
Facility Name
Minneapolis VA Health Care System (Site 105-001), 1 Veterans Drive, Bldg 70
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417
Country
United States
Facility Name
M Health Fairview University of Minnesota Medical Center (Site 112-001), 500 Harvard St. SE.
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
University of Mississippi Medical Center (Site 202-005), 2500 North State Street
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
VA St. Louis Healthcare System (Site 074-027), 915 North Grand Blvd., Rm. C201
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63106
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center/Mary Hitchcock Memorial Hospital (Site 301-024), One Medical Center Drive
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Cooper University Hospital (Site 019-001), One Cooper Plaza
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
Lincoln Medical Center (New York Health and Hospitals/Lincoln) (Site 003-016), 234 E. 149th Street
City
Bronx
State/Province
New York
ZIP/Postal Code
10451
Country
United States
Facility Name
Montefiore Medical Center Weiler Hospital (Site 206-003), 1825 Eastchester Road
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Montefiore Medical Center Moses Hospital (Site 206-001), 111 E. 210th Street
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
SUNY Downstate Medical Center (Site 033-001), 450 Clarkson Ave.
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
Maimonides Medical Center (Site 033-002), 4802 10th Avenue
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11219
Country
United States
Facility Name
Ichan School of Medicine at Mount Sinai (Site 301-012), One Gustave L. Levy Place, Box 1620
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Duke University Hospital (Site 301-006), 2301 Erwin Road
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Wake Forest University Health Sciences (Site 210-001), Medical Center Blvd
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
University of Cincinnati Medical Center (Site 207-003), 234 Goodman Ave.
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
University Hospitals Cleveland Medical Center (Site 108-001), 11100 Euclid Avenue
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Cleveland Clinic Fairview Hospital (Site 207-005), 18101 Lorain Avenue
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44111
Country
United States
Facility Name
Cleveland Clinic Foundation (Site 207-001), 9500 Euclid Avenue
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Cleveland Clinic Marymount Hospital (Site 207-006), 12300 McCraken Road
City
Garfield Heights
State/Province
Ohio
ZIP/Postal Code
44125
Country
United States
Facility Name
Oregon Health & Science University (Site 208-003), 3181 SW Sam Jackson Park Rd.
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239-3098
Country
United States
Facility Name
Portland VA Healthcare System (Site 074-024), 3710 SW. US Veterans Hospital Road
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
UPMC Magee-Womens Hospital (Site 209-003), 300 Halket Street
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
UPMC Presbyterian Hospital (Site 209-001), 200 Lothrop Street
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
UPMC Shadyside Hospital (Site 209-005), 5230 Centre Avenue
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Rhode Island Hospital (Site 080-036), 593 Eddy Street
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
The Miriam Hospital (Site 080-039), 164 Summit Ave.
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
VA Providence Healthcare System (Site 074-025), 830 Chalkstone Ave.
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02908
Country
United States
Facility Name
Ralph H. Johnson VA Medical Center (Site 074-015), 109 Bee Street
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29401
Country
United States
Facility Name
MUSC Research Nexus Clinic (Site 210-002), 96 Jonathan Lucas St., CSB 214
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
MUSC Health Florence Medical Center (Site 210-006), 805 Pamplico Highway
City
Florence
State/Province
South Carolina
ZIP/Postal Code
29505
Country
United States
Facility Name
VA TVHS Nashville Campus (Site 074-022), 1310 24th Avenue South
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Facility Name
Vanderbilt University Medical Center (Site 212-001), 1211 Medical Center Drive
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Hendrick Medical Center (Site 080-014), 1900 Pine Street
City
Abilene
State/Province
Texas
ZIP/Postal Code
79601
Country
United States
Facility Name
CHRISTUS Spohn Shoreline Hospital (Site 080-001), 600 Elizabeth Street
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78404
Country
United States
Facility Name
Parkland Health and Hospital Systems (Site 084-002), 5200 Harry Hines Blvd
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
UT Southwestern Medical Center (Site 084-001), 1936 Amelia Court, 2nd Floor
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Baylor, Scott and White Health (Site 301-003), Baylor University Medical Center, 3500 Gaston Ave.
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Memorial Hermann Hospital (Site 203-006), 6411 Fannin Street
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Michael E. DeBakey Veterans Affairs Medical Center (MEDV AMC) (Site 074-006), 2002 Holcombe Blvd.
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Texas Heart Institute (Site 301-017), 6770 Bertner, MC4-266
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
CHRISTUS Good Shepherd Medical Center (Site 080-031), 700 E. Marshall Ave.
City
Longview
State/Province
Texas
ZIP/Postal Code
75601
Country
United States
Facility Name
Intermountain Medical Center (Site 211-001), 5121 South Cottonwood Street
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
University of Utah Hospital (Site 211-002), 419 Wakara Way, Suite 207
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
Facility Name
LDS Hospital (Site 211-004), 8th Ave. C Street
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84143
Country
United States
Facility Name
University of Virginia Health Systems (Site 301-021), 1215 Lee Street
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
Virginia Commonwealth University Health System (Site 210-005), 1250 East Marshall Street
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Carilion Roanoke Memorial Hospital (Site 080-018), 1906 Belleview Avenue
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Facility Name
Salem VA Medical Center (Site 074-014), 1970 Roanoke Blvd.
City
Salem
State/Province
Virginia
ZIP/Postal Code
24153
Country
United States
Facility Name
Harborview Medical Center (Site 208-001), 325 9th Avenue
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Swedish Hospital First Hill (Site 208-005), 747 Broadway
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
University of Washington Medical Center - Montlake (Site 208-006), 1959 NE Pacific Street
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
West Virginia University (Site 301-023), One Medical Center Drive
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Name
Aalborg Hospital (Site 625-005), Hobrovej 18
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Facility Name
Aarhus Universitetshospital, Skejby (Site 625-002), Department of Infectious Diseases, Palle Juul-Hensens Boulevard 99
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Righospitalet (Site 625-006), Blegdamsvej 9,
City
Copenhagen Ø
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Bispebjerg Hospital (Site 625-013), Bispebjerg Bakke 23
City
Copenhagen
ZIP/Postal Code
2400
Country
Denmark
Facility Name
Herlev/Gentofte Hospital (Site 625-012), Medicinsk Afdeling, Herlev Ringvej 75
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Nordsjællands Hospital (Site 625-009), Dyrehavevej 29
City
Hillerød
ZIP/Postal Code
3400
Country
Denmark
Facility Name
Hvidovre University Hospital, Department of Infectious Diseases (Site 625-001), Kettegård allé 30
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
Facility Name
Kolding Sygehus (Site 625-011), Medicinsk Afdeling, Sygehusvej 24
City
Kolding
ZIP/Postal Code
6000
Country
Denmark
Facility Name
Odense University Hospital (Site 625-004), Infektionsmedicinsk Forskningsenhed, J.B. Winsløwsgade 4
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Zealand University Hospital, Roskilde (Site 625-010), Sygehusvej 10
City
Roskilde
ZIP/Postal Code
4000
Country
Denmark
Facility Name
Democritus University of Thrace (Site 635-021), University General Hospital of Alexandroupolis, Dragana
City
Alexandroupolis
State/Province
Evros
ZIP/Postal Code
68131
Country
Greece
Facility Name
Evangelismos COVID-19 Unit, (Site 635-020), 1st Dept. of Pulmonary and Critical Care Medicine, Evangelismos General Hospital, Dept., Ipsilantou 45-47
City
Athens
ZIP/Postal Code
106 76
Country
Greece
Facility Name
1st Respiratory Medicine Dept., Athens University Medical School (Site 635-015), Athens Hospital for Diseases of the Chest "Sotiria Hospital", 152 Mesogeion Ave.
City
Athens
ZIP/Postal Code
115 27
Country
Greece
Facility Name
3rd Dept. of Medicine, Medical School, NKUA (Site 635-022), Sotiria General Hospital, 152 Mesogeion Ave.
City
Athens
ZIP/Postal Code
115 27
Country
Greece
Facility Name
Attikon University General Hospital (Site 635-009), 4th Dept. of Internal Medicine, Medical School, National and Kapodistrian University of Athens, 1 Rimini St., Haidari
City
Athens
ZIP/Postal Code
124 62
Country
Greece
Facility Name
Institute of Human Virology Nigeria (IHVN) (Site 612-601), Plot 252, Herbert Macaulay Way, Central Business District
City
Abuja
Country
Nigeria
Facility Name
Wojewódzki Szpital Zakazny (Site 625-302), Wolska 37
City
Warsaw
ZIP/Postal Code
01-201
Country
Poland
Facility Name
Tan Tock Seng Hospital (Site 612-201), National Centre for Infectious Diseases (NCID), 11 Jalan Tan Tock Seng
City
Singapore
ZIP/Postal Code
308433
Country
Singapore
Facility Name
Hospital Universitari Germans Trias i Pujol (Site 626-003), Infectious Disease Unit, Second Floor, Building Maternal, Road Canyet s/n
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital Universitari Arnau de Vilanova (Site 626-035), Av. Alcalde Rovira Roure 80
City
Lleida
State/Province
Leida
ZIP/Postal Code
25198
Country
Spain
Facility Name
Hospital Del Mar (Site 626-025), Paseo Maritimo 25-29
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron (Site 626-033), Passeig de la Vall d'Hebron 119-129
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clínic de Barcelona (Site 626-004), Carrer de Villaroel 170
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Universitario de Bellvitge (Site 626-034), Carrer de la Feixa Llarga, s/n
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital General Universitario Gregorio Marañón (Site 626-001), Dr. Esquerdo, 46
City
Madrid
ZIP/Postal Code
28017
Country
Spain
Facility Name
Hospital Clínico San Carlos (Site 626-017), Enfermedades infecciosas, C/Martin Lagos CN
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
UCICEC (Clinical Trial Unit) Hospital Universitario La Paz (Site 626-012), Paseo de la Castellana 261, 2a planta Hospital Maternal
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
University Hospital Zurich (Site 621-201), Department of Infectious Diseases and Hospital Epidemiology, Raemistrasse 100
City
Zürich
State/Province
Zurich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
MRC/UVRI and LSHTM Uganda Research Unit (Site 634-601), Entebbe Regional Referral Hospital
City
Entebbe
Country
Uganda
Facility Name
Gulu Regional Referral Hospital (Site 634-603), Laroo Division, PO Box 160
City
Gulu
Country
Uganda
Facility Name
Makerere University Lung Institute (Site 634-604), New Mulago Hospital Complex, Mulago Hill
City
Kampala
Country
Uganda
Facility Name
St. Francis Hospital, Nsambya (Site 634-607), Nsambya Road Nsambya Hill, P.O. Box 7146
City
Kampala
Country
Uganda
Facility Name
Lira Regional Referral Hospital (Site 634-605)
City
Lira
Country
Uganda
Facility Name
Masaka Regional Referral Hospital (Site 634-606), MRC/UVRI and LSHTM Uganda Research Unit, Plot 6 Circle Road, PO Box 556
City
Masaka
Country
Uganda
Facility Name
Royal Victoria Infirmary (Site 634-007), Queen Victoria Road
City
Newcastle Upon Tyne
State/Province
Northumbria
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
Facility Name
Royal Free Hospital (Site 634-006), Pond Street, Hampstead
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
Guy's and St. Thomas' NHS Foundation Trust (Site 634-011)
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35939810
Citation
ACTIV-3/TICO Study Group; Barkauskas C, Mylonakis E, Poulakou G, Young BE, Vock DM, Siegel L, Engen N, Grandits G, Mosaly NR, Vekstein AM, Rogers R, Shehadeh F, Kaczynski M, Mylona EK, Syrigos KN, Rapti V, Lye DC, Hui DS, Leither L, Knowlton KU, Jain MK, Marines-Price R, Osuji A, Overcash JS, Kalomenidis I, Barmparessou Z, Waters M, Zepeda K, Chen P, Torbati S, Kiweewa F, Sebudde N, Almasri E, Hughes A, Bhagani SR, Rodger A, Sandkovsky U, Gottlieb RL, Nnakelu E, Trautner B, Menon V, Lutaakome J, Matthay M, Robinson P, Protopapas K, Koulouris N, Kimuli I, Baduashvili A, Braun DL, Gunthard HF, Ramachandruni S, Kidega R, Kim K, Hatlen TJ, Phillips AN, Murray DD, Jensen TO, Padilla ML, Accardi EX, Shaw-Saliba K, Dewar RL, Teitelbaum M, Natarajan V, Laverdure S, Highbarger HC, Rehman MT, Vogel S, Vallee D, Crew P, Atri N, Schechner AJ, Pett S, Hudson F, Badrock J, Touloumi G, Brown SM, Self WH, North CM, Ginde AA, Chang CC, Kelleher A, Nagy-Agren S, Vasudeva S, Looney D, Nguyen HH, Sanchez A, Weintrob AC, Grund B, Sharma S, Reilly CS, Paredes R, Bednarska A, Gerry NP, Babiker AG, Davey VJ, Gelijns AC, Higgs ES, Kan V, Matthews G, Thompson BT, Legenne P, Chandra R, Lane HC, Neaton JD, Lundgren JD. Efficacy and Safety of Ensovibep for Adults Hospitalized With COVID-19 : A Randomized Controlled Trial. Ann Intern Med. 2022 Sep;175(9):1266-1274. doi: 10.7326/M22-1503. Epub 2022 Aug 9.
Results Reference
derived
PubMed Identifier
35817072
Citation
ACTIV-3-Therapeutics for Inpatients with COVID-19 (TICO) Study Group. Tixagevimab-cilgavimab for treatment of patients hospitalised with COVID-19: a randomised, double-blind, phase 3 trial. Lancet Respir Med. 2022 Oct;10(10):972-984. doi: 10.1016/S2213-2600(22)00215-6. Epub 2022 Jul 8. Erratum In: Lancet Respir Med. 2022 Nov 7;:
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
35298440
Citation
Wick KD, Siegel L, Neaton JD, Oldmixon C, Lundgren J, Dewar RL, Lane HC, Thompson BT, Matthay MA; ACTIV-3/TICO study group. RAGE has potential pathogenetic and prognostic value in nonintubated hospitalized patients with COVID-19. JCI Insight. 2022 May 9;7(9):e157499. doi: 10.1172/jci.insight.157499.
Results Reference
derived
PubMed Identifier
34953520
Citation
ACTIV-3/Therapeutics for Inpatients with COVID-19 (TICO) Study Group. Efficacy and safety of two neutralising monoclonal antibody therapies, sotrovimab and BRII-196 plus BRII-198, for adults hospitalised with COVID-19 (TICO): a randomised controlled trial. Lancet Infect Dis. 2022 May;22(5):622-635. doi: 10.1016/S1473-3099(21)00751-9. Epub 2021 Dec 23.
Results Reference
derived
PubMed Identifier
34928698
Citation
ACTIV-3/TICO Bamlanivimab Study Group; Lundgren JD, Grund B, Barkauskas CE, Holland TL, Gottlieb RL, Sandkovsky U, Brown SM, Knowlton KU, Self WH, Files DC, Jain MK, Benfield T, Bowdish ME, Leshnower BG, Baker JV, Jensen JU, Gardner EM, Ginde AA, Harris ES, Johansen IS, Markowitz N, Matthay MA, Ostergaard L, Chang CC, Goodman AL, Chang W, Dewar RL, Gerry NP, Higgs ES, Highbarger H, Murray DD, Murray TA, Natarajan V, Paredes R, Parmar MKB, Phillips AN, Reilly C, Rupert AW, Sharma S, Shaw-Saliba K, Sherman BT, Teitelbaum M, Wentworth D, Cao H, Klekotka P, Babiker AG, Davey VJ, Gelijns AC, Kan VL, Polizzotto MN, Thompson BT, Lane HC, Neaton JD. Responses to a Neutralizing Monoclonal Antibody for Hospitalized Patients With COVID-19 According to Baseline Antibody and Antigen Levels : A Randomized Controlled Trial. Ann Intern Med. 2022 Feb;175(2):234-243. doi: 10.7326/M21-3507. Epub 2021 Dec 21.
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
PubMed Identifier
33356051
Citation
ACTIV-3/TICO LY-CoV555 Study Group; Lundgren JD, Grund B, Barkauskas CE, Holland TL, Gottlieb RL, Sandkovsky U, Brown SM, Knowlton KU, Self WH, Files DC, Jain MK, Benfield T, Bowdish ME, Leshnower BG, Baker JV, Jensen JU, Gardner EM, Ginde AA, Harris ES, Johansen IS, Markowitz N, Matthay MA, Ostergaard L, Chang CC, Davey VJ, Goodman A, Higgs ES, Murray DD, Murray TA, Paredes R, Parmar MKB, Phillips AN, Reilly C, Sharma S, Dewar RL, Teitelbaum M, Wentworth D, Cao H, Klekotka P, Babiker AG, Gelijns AC, Kan VL, Polizzotto MN, Thompson BT, Lane HC, Neaton JD. A Neutralizing Monoclonal Antibody for Hospitalized Patients with Covid-19. N Engl J Med. 2021 Mar 11;384(10):905-914. doi: 10.1056/NEJMoa2033130. Epub 2020 Dec 22.
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/technical-guidance/patient-management
Description
WHO COVID-19 treatment guidelines

Learn more about this trial

ACTIV-3: Therapeutics for Inpatients With COVID-19

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