VIR-7831 for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial)
- Conditions
- COVID-19
- Interventions
- Biological: VIR-7831Biological: PlaceboBiological: Remdesivir
- Registration Number
- NCT05780281
- Brief Summary
This study looks at the safety and effectiveness of VIR-7831 in treating COVID-19 in people who have been hospitalized with the infection. Participants in the study will be treated with either VIR-7831 plus current standard of care (SOC), or with placebo plus current SOC. This is ACTIV-3/TICO Treatment Trial H2.
- Detailed Description
This is a treatment trial of the ACTIV-3/TICO master protocol (NCT04501978) to evaluate the safety and efficacy of VIR-7831 in hospitalized patients infected with COVID-19.
This is a randomized, blinded, controlled sub-study of VIR-7831 plus current standard of care (SOC) against placebo plus current SOC. The placebo arm may be shared across other sub-studies of the ACTIV-3/TICO master protocol. 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. The pace of enrollment with be initially restricted, and there will be an early review of safety data by the DSMB. 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.
If VIR-7831 passes the 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.
This trial 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 367
Refer to the master protocol (NCT04501978)
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description VIR-7831 plus SOC VIR-7831 * 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 plus SOC Placebo * Placebo administered by IV infusion * Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion Placebo plus SOC Remdesivir * Placebo administered by IV infusion * Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion VIR-7831 plus SOC Remdesivir * 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
- Primary Outcome Measures
Name Time Method Number of Participants With an Ordinal Outcome on Day 5 Status on Day 5 Ordinal outcome with 7 mutually exclusive categories
Number of Participants With Sustained Recovery Through Day 90 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
Name Time Method Number of Participants Who Died From All Causes Through Day 90 All-cause mortality
Number of Participants With a Safety Outcome Through Day 28 Through Day 28 Death, SAE, clinical organ failure, serious infections, or Grade 3 or 4 event through Day 28
Number of Participants With a Safety Outcome Through Day 5 Through Day 5 Death, SAE, clinical organ failure, serious infections, or Grade 3 or 4 event through Day 5
Number of Participants With a Safety Outcome Through Day 90 Through Day 90 Death, SAE, clinical organ failure, serious infections through Day 90
Trial Locations
- Locations (105)
University of Mississippi Medical Center (Site 202-005), 2500 North State Street
🇺🇸Jackson, Mississippi, United States
UPMC Shadyside Hospital (Site 209-005), 5230 Centre Avenue
🇺🇸Pittsburgh, Pennsylvania, United States
CHRISTUS Spohn Shoreline Hospital (Site 080-001), 600 Elizabeth Street
🇺🇸Corpus Christi, Texas, United States
Parkland Health and Hospital Systems (Site 084-002), 5200 Harry Hines Blvd
🇺🇸Dallas, Texas, United States
Baylor, Scott and White Health (Site 301-003), Baylor University Medical Center, 3500 Gaston Ave.
🇺🇸Dallas, Texas, United States
Hospital Del Mar (Site 626-025), Paseo Maritimo 25-29
🇪🇸Barcelona, Spain
Hospital Universitari Arnau de Vilanova (Site 626-035), Av. Alcalde Rovira Roure 80
🇪🇸Lleida, Leida, Spain
Hospital Universitari Vall d'Hebron (Site 626-033), Passeig de la Vall d'Hebron 119-129
🇪🇸Barcelona, Spain
Hospital ClÃnico San Carlos (Site 626-017), Enfermedades infecciosas, C/Martin Lagos CN
🇪🇸Madrid, Spain
MedStar Georgetown University Hospital (Site 067-001), 3800 Reservoir Road NW
🇺🇸Washington, District of Columbia, United States
VA Loma Linda Healthcare System (Site 074-017), 11201 Benton Street
🇺🇸Loma Linda, California, United States
Cedars-Sinai Medical Center (Site 208-002), 8700 Beverly Blvd.
🇺🇸Los Angeles, California, United States
Memorial Healthcare System (Site 648-002), Memorial Regional Hospital, 3501 Johnson Street
🇺🇸Hollywood, Florida, United States
Ronald Reagan UCLA Medical Center (Site 203-002), 757 Westwood Plaza
🇺🇸Los Angeles, California, United States
Hospital Universitario de Bellvitge (Site 626-034), Carrer de la Feixa Llarga, s/n
🇪🇸Barcelona, Spain
Tan Tock Seng Hospital (Site 612-201), National Centre for Infectious Diseases (NCID), 11 Jalan Tan Tock Seng
🇸🇬Singapore, Singapore
Royal Free Hospital (Site 634-006), Pond Street, Hampstead
🇬🇧London, United Kingdom
Royal Victoria Infirmary (Site 634-007), Queen Victoria Road
🇬🇧Newcastle Upon Tyne, Northumbria, United Kingdom
Guy's and St. Thomas' NHS Foundation Trust (Site 634-011)
🇬🇧London, United Kingdom
UCICEC (Clinical Trial Unit) Hospital Universitario La Paz (Site 626-012), Paseo de la Castellana 261, 2a planta Hospital Maternal
🇪🇸Madrid, Spain
Wojewódzki Szpital Zakazny (Site 625-302), Wolska 37
🇵🇱Warsaw, Poland
Hospital ClÃnic de Barcelona (Site 626-004), Carrer de Villaroel 170
🇪🇸Barcelona, Spain
Miami VAMC (Site 074-003), 1201 NW 16 Street
🇺🇸Miami, Florida, United States
Hoag Memorial Hospital Presbyterian (Site 080-026), One Hoag Drive
🇺🇸Newport Beach, California, United States
Stanford University Hospital & Clinics (Site 203-003), 300 Pasteur Dr.
🇺🇸Stanford, California, United States
Baycare Health System (Site 301-025), Morton Plant Hospital, 300 Pinellas Street
🇺🇸Clearwater, Florida, United States
Washington DC VA Medical Center (Site 009-004), 50 Irving Street NW
🇺🇸Washington, District of Columbia, United States
Cooper University Hospital (Site 019-001), One Cooper Plaza
🇺🇸Camden, New Jersey, United States
UT Southwestern Medical Center (Site 084-001), 1936 Amelia Court, 2nd Floor
🇺🇸Dallas, Texas, United States
Hospital General Universitario Gregorio Marañón (Site 626-001), Dr. Esquerdo, 46
🇪🇸Madrid, Spain
Community Regional Medical Center (Site 203-005), 2823 Fresno Street
🇺🇸Fresno, California, United States
VA Long Beach Healthcare System (Site 074-026), 5901 East 7th Street (09/151-M2)
🇺🇸Long Beach, California, United States
Keck Hospital of USC (Site 301-020), 1500 San Pablo Street
🇺🇸Los Angeles, California, United States
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center (Site 066-002), 1124 W. Carson Street, CDCRC Building
🇺🇸Torrance, California, United States
Emory University (Site 301-008), The Emory Clinic, Bldg. A, Suite 2236, 1365 Clifton Rd., NE
🇺🇸Atlanta, Georgia, United States
University of Kentucky Hospital (Site 210-004), 1000 South Limestone St.
🇺🇸Lexington, Kentucky, United States
Lincoln Medical Center (New York Health and Hospitals/Lincoln) (Site 003-016), 234 E. 149th Street
🇺🇸Bronx, New York, United States
Lutheran Medical Group (Site 301-010), 7916 W. Jefferson Boulevard
🇺🇸Fort Wayne, Indiana, United States
Montefiore Medical Center Weiler Hospital (Site 206-003), 1825 Eastchester Road
🇺🇸Bronx, New York, United States
Montefiore Medical Center Moses Hospital (Site 206-001), 111 E. 210th Street
🇺🇸Bronx, New York, United States
Cleveland Clinic Fairview Hospital (Site 207-005), 18101 Lorain Avenue
🇺🇸Cleveland, Ohio, United States
Cleveland Clinic Foundation (Site 207-001), 9500 Euclid Avenue
🇺🇸Cleveland, Ohio, United States
University of Cincinnati Medical Center (Site 207-003), 234 Goodman Ave.
🇺🇸Cincinnati, Ohio, United States
Cleveland Clinic Marymount Hospital (Site 207-006), 12300 McCraken Road
🇺🇸Garfield Heights, Ohio, United States
UPMC Magee-Womens Hospital (Site 209-003), 300 Halket Street
🇺🇸Pittsburgh, Pennsylvania, United States
UPMC Presbyterian Hospital (Site 209-001), 200 Lothrop Street
🇺🇸Pittsburgh, Pennsylvania, United States
Rhode Island Hospital (Site 080-036), 593 Eddy Street
🇺🇸Providence, Rhode Island, United States
The Miriam Hospital (Site 080-039), 164 Summit Ave.
🇺🇸Providence, Rhode Island, United States
University of Virginia Health Systems (Site 301-021), 1215 Lee Street
🇺🇸Charlottesville, Virginia, United States
Michael E. DeBakey Veterans Affairs Medical Center (MEDV AMC) (Site 074-006), 2002 Holcombe Blvd.
🇺🇸Houston, Texas, United States
Texas Heart Institute (Site 301-017), 6770 Bertner, MC4-266
🇺🇸Houston, Texas, United States
Salem VA Medical Center (Site 074-014), 1970 Roanoke Blvd.
🇺🇸Salem, Virginia, United States
Swedish Hospital First Hill (Site 208-005), 747 Broadway
🇺🇸Seattle, Washington, United States
UCSF Medical Center at Mount Zion (Site 203-007), 1600 Divisadero St.
🇺🇸San Francisco, California, United States
Hennepin Healthcare (Site 027-001), 701 Park Avenue
🇺🇸Minneapolis, Minnesota, United States
San Francisco VAMC (Site 074-002), 4150 Clement St.
🇺🇸San Francisco, California, United States
UCSF Medical Center (Site 203-001), Moffitt-Long Hospital, 505 Parnassus Ave.
🇺🇸San Francisco, California, United States
Minneapolis VA Health Care System (Site 105-001), 1 Veterans Drive, Bldg 70
🇺🇸Minneapolis, Minnesota, United States
Duke University Hospital (Site 301-006), 2301 Erwin Road
🇺🇸Durham, North Carolina, United States
VA TVHS Nashville Campus (Site 074-022), 1310 24th Avenue South
🇺🇸Nashville, Tennessee, United States
Vanderbilt University Medical Center (Site 212-001), 1211 Medical Center Drive
🇺🇸Nashville, Tennessee, United States
LDS Hospital (Site 211-004), 8th Ave. C Street
🇺🇸Salt Lake City, Utah, United States
Gulu Regional Referral Hospital (Site 634-603), Laroo Division, PO Box 160
🇺🇬Gulu, Uganda
Makerere University Lung Institute (Site 634-604), New Mulago Hospital Complex, Mulago Hill
🇺🇬Kampala, Uganda
MRC/UVRI and LSHTM Uganda Research Unit (Site 634-601), Entebbe Regional Referral Hospital
🇺🇬Entebbe, Uganda
St. Francis Hospital, Nsambya (Site 634-607), Nsambya Road Nsambya Hill, P.O. Box 7146
🇺🇬Kampala, Uganda
Lira Regional Referral Hospital (Site 634-605)
🇺🇬Lira, Uganda
Masaka Regional Referral Hospital (Site 634-606), MRC/UVRI and LSHTM Uganda Research Unit, Plot 6 Circle Road, PO Box 556
🇺🇬Masaka, Uganda
Minneapolis Heart Institute Foundation (Site 301-026), Abbott Northwestern Hospital, 920 E 28th St. #100
🇺🇸Minneapolis, Minnesota, United States
Cotton O'Neil Clinical Research Center (Site 080-030), Stormont Vail Health, 1500 SW 10th Avenue
🇺🇸Topeka, Kansas, United States
Henry Ford Health System, Henry Ford Hospital (Site 014-001), 2799 W. Grand Blvd.
🇺🇸Detroit, Michigan, United States
Bispebjerg Hospital (Site 625-013), Bispebjerg Bakke 23
🇩🇰Copenhagen, Denmark
Aalborg Hospital (Site 625-005), Hobrovej 18
🇩🇰Aalborg, Denmark
Aarhus Universitetshospital, Skejby (Site 625-002), Department of Infectious Diseases, Palle Juul-Hensens Boulevard 99
🇩🇰Aarhus N, Denmark
Righospitalet (Site 625-006), Blegdamsvej 9,
🇩🇰Copenhagen Ø, Denmark
Herlev/Gentofte Hospital (Site 625-012), Medicinsk Afdeling, Herlev Ringvej 75
🇩🇰Herlev, Denmark
Nordsjællands Hospital (Site 625-009), Dyrehavevej 29
🇩🇰Hillerød, Denmark
Hvidovre University Hospital, Department of Infectious Diseases (Site 625-001), Kettegård allé 30
🇩🇰Hvidovre, Denmark
Kolding Sygehus (Site 625-011), Medicinsk Afdeling, Sygehusvej 24
🇩🇰Kolding, Denmark
Odense University Hospital (Site 625-004), Infektionsmedicinsk Forskningsenhed, J.B. Winsløwsgade 4
🇩🇰Odense, Denmark
Zealand University Hospital, Roskilde (Site 625-010), Sygehusvej 10
🇩🇰Roskilde, Denmark
University of Maryland Medical Center (Site 301-019), 22 South Greene Street
🇺🇸Baltimore, Maryland, United States
Massachusetts General Hospital (Site 202-002), 55 Fruit Street
🇺🇸Boston, Massachusetts, United States
Bay Pines VAMC (Site 074-004), 10000 Bay Pines Blvd., Bldg. 100, Room 5B-104
🇺🇸Bay Pines, Florida, United States
North Florida/South Georgia Veterans Health System (Site 074-011), 1601 SW. Archer Road
🇺🇸Gainesville, Florida, United States
Hospital Universitari Germans Trias i Pujol (Site 626-003), Infectious Disease Unit, Second Floor, Building Maternal, Road Canyet s/n
🇪🇸Badalona, Barcelona, Spain
Beth Israel Deaconess Medical Center (Site 202-001), 330 Brookline Ave.
🇺🇸Boston, Massachusetts, United States
University of Utah Hospital (Site 211-002), 419 Wakara Way, Suite 207
🇺🇸Salt Lake City, Utah, United States
University Hospital Zurich (Site 621-201), Department of Infectious Diseases and Hospital Epidemiology, Raemistrasse 100
🇨ðŸ‡Zürich, Zurich, Switzerland
Baystate Medical Center (Site 201-001), 759 Chestnut Street
🇺🇸Springfield, Massachusetts, United States
Southern Arizona VA Healthcare System (Site 074-009), 3601 S. 6th Ave.
🇺🇸Tucson, Arizona, United States
West Virginia University (Site 301-023), One Medical Center Drive
🇺🇸Morgantown, West Virginia, United States
Intermountain Medical Center (Site 211-001), 5121 South Cottonwood Street
🇺🇸Murray, Utah, United States
Banner University Medical Center Tucson (Site 206-004), 1625 N. Campbell Avenue
🇺🇸Tucson, Arizona, United States
Dartmouth-Hitchcock Medical Center/Mary Hitchcock Memorial Hospital (Site 301-024), One Medical Center Drive
🇺🇸Lebanon, New Hampshire, United States
Denver Public Health (Site 017-004), 660 Bannock St., MC2600 (Infectious Disease Clinic)
🇺🇸Denver, Colorado, United States
National Jewish Health / St. Joseph Hospital (Site 204-003), 1400 Jackson Street
🇺🇸Denver, Colorado, United States
Hillsborough County Health Department, University of South Florida (Site 032-001)
🇺🇸Tampa, Florida, United States
Oregon Health & Science University (Site 208-003), 3181 SW Sam Jackson Park Rd.
🇺🇸Portland, Oregon, United States
University of Colorado Hospital (Site 204-001), 12605 E. 16th Avenue
🇺🇸Aurora, Colorado, United States
Wake Forest University Health Sciences (Site 210-001), Medical Center Blvd
🇺🇸Winston-Salem, North Carolina, United States
University of Michigan (Site 205-001), 1500 East Medical Center Drive
🇺🇸Ann Arbor, Michigan, United States
Ochsner Clinic Foundation (Site 301-015), 1514 Jefferson Highway
🇺🇸New Orleans, Louisiana, United States
MUSC Research Nexus Clinic (Site 210-002), 96 Jonathan Lucas St., CSB 214
🇺🇸Charleston, South Carolina, United States
CHRISTUS Good Shepherd Medical Center (Site 080-031), 700 E. Marshall Ave.
🇺🇸Longview, Texas, United States