LY3819253 (LY-CoV555) for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial)
COVID-19
About this trial
This is an interventional treatment trial for COVID-19 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, TICO
Eligibility Criteria
Inclusion Criteria: Refer to the master protocol (NCT04501978) Exclusion Criteria: Refer to the master protocol (NCT04501978) Additional Criteria: Non-pregnant female participants who are of reproductive potential and male participants who are able to father a child must abstain from male/female sexual intercourse or agree to use two forms of effective contraception, where at least one form is highly effective (less than 1% failure rate), for the entirety of the study and for 90 days after investigational agent is administered. Highly effective methods of contraception (less than 1% failure rate) include, but are not limited to: combination oral contraceptives implanted contraceptives intrauterine devices Effective methods of contraception include, but are not limited to: diaphragms and cervical caps with spermicide cervical sponges condoms with spermicide NOTE: Use of male and female condoms as a double barrier method is not considered acceptable due to the high failure rate when these barrier methods are combined. Barrier protection methods without concomitant use of a spermicide are not an effective or acceptable method of contraception. Periodic abstinence (e.g., calendar, ovulation, symptothermal, postovulation methods), and withdrawal are not acceptable methods of contraception. Participants not of reproductive potential are eligible without requiring the use of a contraceptive method. Participant-reported history is acceptable documentation of surgical sterilization and menopause. Participants with pregnant partners should use condoms during vaginal intercourse through 90 days after investigational agent administration. Participants should refrain from sperm donation through 90 days after investigational agent administration. NOTE: Reproductive potential is defined as patients who have reached menarche, who have not been post-menopausal for at least 12 consecutive months with follicle-stimulating hormone (FSH) ≥ 40 IU/ml or 24 consecutive months if an FSH is not available, who have not undergone surgical sterilization, who do not have other clinical condition that could induce amenorrhea, who are not taking medications such as oral contraceptives, hormones, gonadotropin releasing hormone, antiestrogens, selective estrogen receptor modulators (SERMs) or chemotherapy that could induce amenorrhea. Individuals with permanent infertility due to an alternate medical cause (e.g. Mullerian agenesis, androgen insensitivity), investigator discretion should be applied.
Sites / Locations
- Banner University Medical Center Tucson (Site 206-004), 1625 N. Campbell Avenue
- Community Regional Medical Center (Site 203-005), 2823 Fresno Street
- Keck Hospital of USC (Site 301-020), 1500 San Pablo Street
- 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.
- University of Colorado Hospital (Site 204-001), 12605 E. 16th Avenue
- Denver Public Health (Site 017-004), 660 Bannock St., MC2600 (Infectious Disease Clinic)
- MedStar Georgetown University Hospital (Site 067-001), 3800 Reservoir Road NW
- Miami VAMC (Site 074-003), 1201 NW 16 Street
- Emory University (Site 301-008), The Emory Clinic, Bldg. A, Suite 2236, 1365 Clifton Rd., NE
- 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
- 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.
- Hennepin Healthcare (Site 027-001), 701 Park Avenue
- University of Mississippi Medical Center (Site 202-005), 2500 North State Street
- Dartmouth-Hitchcock Medical Center/Mary Hitchcock Memorial Hospital (Site 301-024), One Medical Center Drive
- Montefiore Medical Center Weiler Hospital (Site 206-003), 1825 Eastchester Road
- Montefiore Medical Center Moses Hospital (Site 206-001), 111 E. 210th Street
- Duke University Hospital (Site 301-006), 2301 Erwin Road
- Wake Forest University Health Sciences (Site 210-001), Medical Center Blvd
- 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.
- Vanderbilt University Medical Center (Site 212-001), 1211 Medical Center Drive
- 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.
- Intermountain Medical Center (Site 211-001), 5121 South Cottonwood Street
- University of Utah Hospital (Site 211-002), 419 Wakara Way, Suite 207
- University of Virginia Health Systems (Site 301-021), 1215 Lee Street
- Virginia Commonwealth University Health System (Site 210-005), 1250 East Marshall Street
- Harborview Medical Center (Site 208-001), 325 9th Avenue
- 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,
- 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
- 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 Del Mar (Site 626-025), Paseo Maritimo 25-29
- Hospital Clínic de Barcelona (Site 626-004), Carrer de Villaroel 170
- 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
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
LY3819253 plus SOC
Placebo plus SOC
LY3819253 7000 mg solution (10 vials of 20 mL solution containing 700 mg each); administered by IV infusion Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion
Placebo administered by IV infusion Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion