A Multicenter, Adaptive, Randomized, Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for Hospitalized Patients With COVID-19 (Trial H2: VIR-7831 (GSK4182136))
A Multicenter, Adaptive, Randomized, Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for Hospitalized Patients With COVID-19 (Trial H2: VIR-7831 (GSK4182136))
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.
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.
Inclusion Criteria: Refer to the master protocol (NCT04501978)
Exclusion Criteria: Refer to the master protocol (NCT04501978)
Additional Exclusion Criteria:
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.
Tucson, Arizona 85719, United States
Tucson, Arizona 85723, United States
Fresno, California 93701, United States
Loma Linda, California 92357, United States
Long Beach, California 90822, United States
Los Angeles, California 90033, United States
Los Angeles, California 90048, United States
Los Angeles, California 90095, United States
Newport Beach, California 92663, United States
San Francisco, California 94115, United States
San Francisco, California 94143, United States
Stanford, California 94305, United States
Torrance, California 90502, United States
Aurora, Colorado 80045, United States
Denver, Colorado 80204, United States
Denver, Colorado 80206, United States
Washington D.C., District of Columbia 20007, United States
Washington D.C., District of Columbia 20422, United States
Bay Pines, Florida 33744, United States
Clearwater, Florida 33756, United States
Gainesville, Florida 32608-1197, United States
Hollywood, Florida 33021, United States
Tampa, Florida 33602, United States
Atlanta, Georgia 30322, United States
Fort Wayne, Indiana 46804, United States
Topeka, Kansas 66604, United States
Lexington, Kentucky 40536, United States
New Orleans, Louisiana 70121, United States
Baltimore, Maryland 21201, United States
Boston, Massachusetts 02114, United States
Boston, Massachusetts 02215, United States
Springfield, Massachusetts 01199, United States
Ann Arbor, Michigan 48109, United States
Detroit, Michigan 48202, United States
Minneapolis, Minnesota 55407, United States
Minneapolis, Minnesota 55417, United States
Jackson, Mississippi 39216, United States
Lebanon, New Hampshire 03756, United States
The Bronx, New York 10451, United States
The Bronx, New York 10461, United States
The Bronx, New York 10467, United States
Winston-Salem, North Carolina 27157, United States
Cincinnati, Ohio 45219, United States
Cleveland, Ohio 44111, United States
Garfield Heights, Ohio 44125, United States
Portland, Oregon 97239-3098, United States
Pittsburgh, Pennsylvania 15213, United States
Pittsburgh, Pennsylvania 15213, United States
Pittsburgh, Pennsylvania 15232, United States
Charleston, South Carolina 29425, United States
Nashville, Tennessee 37212, United States
Nashville, Tennessee 37232, United States
Corpus Christi, Texas 78404, United States
Dallas, Texas 75235, United States
Dallas, Texas 75235, United States
Dallas, Texas 75246, United States
Houston, Texas 77030, United States
Longview, Texas 75601, United States
Murray, Utah 84107, United States
Salt Lake City, Utah 84108, United States
Charlottesville, Virginia 22903, United States
Morgantown, West Virginia 26506, United States
Aarhus N, 8200, Denmark
Copenhagen Ø, 2100, Denmark
Hvidovre, 2650, Denmark
Odense, 5000, Denmark
Singapore, 308433, Singapore
Badalona, Barcelona 08916, Spain
Lleida, Leida 25198, Spain
Barcelona, 08035, Spain
Barcelona, 08907, Spain
Madrid, 28017, Spain
Madrid, 28040, Spain
Madrid, 28046, Spain
Zurich, Canton of Zurich 8091, Switzerland
Entebbe, Uganda
Kampala, Uganda
Kampala, Uganda
Masaka, Uganda
Newcastle upon Tyne, Northumbria NE1 4LP, United Kingdom