VIR-7831 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 Exclusion Criteria: Pregnant women Nursing mothers In addition, prior to the initial futility assessment which is performed when approximately 150 participants have been enrolled on VIR-7831 and 150 on placebo, patients on highflow oxygen or non-invasive ventilation (category 5 of the pulmonary ordinal outcome) will be excluded. These patients may be eligible for the trial if the initial futility assessment is passed by this 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.
- Community Regional Medical Center (Site 203-005), 2823 Fresno Street
- 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
- Hoag Memorial Hospital Presbyterian (Site 080-026), One Hoag 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
- MedStar Georgetown University Hospital (Site 067-001), 3800 Reservoir Road 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
- 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
- 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
- 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.
- 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.
- 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.
- MUSC Research Nexus Clinic (Site 210-002), 96 Jonathan Lucas St., CSB 214
- VA TVHS Nashville Campus (Site 074-022), 1310 24th Avenue South
- Vanderbilt University Medical Center (Site 212-001), 1211 Medical Center Drive
- 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.
- 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
- Salem VA Medical Center (Site 074-014), 1970 Roanoke Blvd.
- Swedish Hospital First Hill (Site 208-005), 747 Broadway
- 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
- 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
Experimental
Placebo Comparator
VIR-7831 plus SOC
Placebo plus SOC
VIR-7831 500 mg solution (2 vials of 250 mg); administered as a single 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