VIR-7831 for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial)
NCT ID: NCT05780281
Last Updated: 2023-12-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
367 participants
INTERVENTIONAL
2020-12-16
2022-10-04
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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VIR-7831 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
VIR-7831
VIR-7831 is a fully human neutralizing immunoglobulin G (IgG)-1 kappa monoclonal antibody (mAb) derived from antibody S309 from a survivor of SARS-CoV-1.
Remdesivir
Antiviral agent
Placebo plus SOC
* 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
Commercially available 0.9% sodium chloride solution
Remdesivir
Antiviral agent
Interventions
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VIR-7831
VIR-7831 is a fully human neutralizing immunoglobulin G (IgG)-1 kappa monoclonal antibody (mAb) derived from antibody S309 from a survivor of SARS-CoV-1.
Placebo
Commercially available 0.9% sodium chloride solution
Remdesivir
Antiviral agent
Other Intervention Names
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Eligibility Criteria
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Exclusion Criteria
2. 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.
18 Years
ALL
No
Sponsors
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International Network for Strategic Initiatives in Global HIV Trials (INSIGHT)
NETWORK
University of Copenhagen
OTHER
Medical Research Council
OTHER_GOV
Kirby Institute
OTHER_GOV
Washington D.C. Veterans Affairs Medical Center
FED
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
NETWORK
National Heart, Lung, and Blood Institute (NHLBI)
NIH
US Department of Veterans Affairs
FED
Prevention and Early Treatment of Acute Lung Injury
OTHER
Cardiothoracic Surgical Trials Network
OTHER
Vir Biotechnology, Inc.
INDUSTRY
GlaxoSmithKline
INDUSTRY
University of Minnesota
OTHER
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Jens Lundgren, Prof.
Role: PRINCIPAL_INVESTIGATOR
INSIGHT Copenhagen International Coordinating Centre, Rigshospitalet, University of Copenhagen
James Neaton, Prof.
Role: STUDY_CHAIR
INSIGHT Statistical and Data Management Center, University of Minnesota
Locations
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Banner University Medical Center Tucson (Site 206-004), 1625 N. Campbell Avenue
Tucson, Arizona, United States
Southern Arizona VA Healthcare System (Site 074-009), 3601 S. 6th Ave.
Tucson, Arizona, United States
Community Regional Medical Center (Site 203-005), 2823 Fresno Street
Fresno, California, United States
VA Loma Linda Healthcare System (Site 074-017), 11201 Benton Street
Loma Linda, 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
Cedars-Sinai Medical Center (Site 208-002), 8700 Beverly Blvd.
Los Angeles, California, United States
Ronald Reagan UCLA Medical Center (Site 203-002), 757 Westwood Plaza
Los Angeles, California, United States
Hoag Memorial Hospital Presbyterian (Site 080-026), One Hoag Drive
Newport Beach, California, United States
UCSF Medical Center at Mount Zion (Site 203-007), 1600 Divisadero St.
San Francisco, California, 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
Stanford University Hospital & Clinics (Site 203-003), 300 Pasteur Dr.
Stanford, 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
University of Colorado Hospital (Site 204-001), 12605 E. 16th Avenue
Aurora, Colorado, 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
MedStar Georgetown University Hospital (Site 067-001), 3800 Reservoir Road NW
Washington D.C., District of Columbia, United States
Washington DC VA Medical Center (Site 009-004), 50 Irving Street NW
Washington D.C., District of Columbia, United States
Bay Pines VAMC (Site 074-004), 10000 Bay Pines Blvd., Bldg. 100, Room 5B-104
Bay Pines, Florida, United States
Baycare Health System (Site 301-025), Morton Plant Hospital, 300 Pinellas Street
Clearwater, Florida, United States
North Florida/South Georgia Veterans Health System (Site 074-011), 1601 SW. Archer Road
Gainesville, Florida, United States
Memorial Healthcare System (Site 648-002), Memorial Regional Hospital, 3501 Johnson Street
Hollywood, Florida, United States
Miami VAMC (Site 074-003), 1201 NW 16 Street
Miami, Florida, United States
Hillsborough County Health Department, University of South Florida (Site 032-001)
Tampa, Florida, United States
Emory University (Site 301-008), The Emory Clinic, Bldg. A, Suite 2236, 1365 Clifton Rd., NE
Atlanta, Georgia, United States
Lutheran Medical Group (Site 301-010), 7916 W. Jefferson Boulevard
Fort Wayne, Indiana, United States
Cotton O'Neil Clinical Research Center (Site 080-030), Stormont Vail Health, 1500 SW 10th Avenue
Topeka, Kansas, United States
University of Kentucky Hospital (Site 210-004), 1000 South Limestone St.
Lexington, Kentucky, United States
Ochsner Clinic Foundation (Site 301-015), 1514 Jefferson Highway
New Orleans, Louisiana, United States
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
Beth Israel Deaconess Medical Center (Site 202-001), 330 Brookline Ave.
Boston, Massachusetts, United States
Baystate Medical Center (Site 201-001), 759 Chestnut Street
Springfield, Massachusetts, United States
University of Michigan (Site 205-001), 1500 East Medical Center Drive
Ann Arbor, Michigan, United States
Henry Ford Health System, Henry Ford Hospital (Site 014-001), 2799 W. Grand Blvd.
Detroit, Michigan, United States
Minneapolis Heart Institute Foundation (Site 301-026), Abbott Northwestern Hospital, 920 E 28th St. #100
Minneapolis, Minnesota, United States
Hennepin Healthcare (Site 027-001), 701 Park Avenue
Minneapolis, Minnesota, United States
Minneapolis VA Health Care System (Site 105-001), 1 Veterans Drive, Bldg 70
Minneapolis, Minnesota, United States
University of Mississippi Medical Center (Site 202-005), 2500 North State Street
Jackson, Mississippi, United States
Dartmouth-Hitchcock Medical Center/Mary Hitchcock Memorial Hospital (Site 301-024), One Medical Center Drive
Lebanon, New Hampshire, United States
Cooper University Hospital (Site 019-001), One Cooper Plaza
Camden, New Jersey, United States
Lincoln Medical Center (New York Health and Hospitals/Lincoln) (Site 003-016), 234 E. 149th Street
The Bronx, New York, United States
Montefiore Medical Center Weiler Hospital (Site 206-003), 1825 Eastchester Road
The Bronx, New York, United States
Montefiore Medical Center Moses Hospital (Site 206-001), 111 E. 210th Street
The Bronx, New York, United States
Duke University Hospital (Site 301-006), 2301 Erwin Road
Durham, North Carolina, United States
Wake Forest University Health Sciences (Site 210-001), Medical Center Blvd
Winston-Salem, North Carolina, United States
University of Cincinnati Medical Center (Site 207-003), 234 Goodman Ave.
Cincinnati, Ohio, 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
Cleveland Clinic Marymount Hospital (Site 207-006), 12300 McCraken Road
Garfield Heights, Ohio, United States
Oregon Health & Science University (Site 208-003), 3181 SW Sam Jackson Park Rd.
Portland, Oregon, 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
UPMC Shadyside Hospital (Site 209-005), 5230 Centre Avenue
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
MUSC Research Nexus Clinic (Site 210-002), 96 Jonathan Lucas St., CSB 214
Charleston, South 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
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
UT Southwestern Medical Center (Site 084-001), 1936 Amelia Court, 2nd Floor
Dallas, Texas, United States
Baylor, Scott and White Health (Site 301-003), Baylor University Medical Center, 3500 Gaston Ave.
Dallas, Texas, 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
CHRISTUS Good Shepherd Medical Center (Site 080-031), 700 E. Marshall Ave.
Longview, Texas, United States
Intermountain Medical Center (Site 211-001), 5121 South Cottonwood Street
Murray, Utah, United States
University of Utah Hospital (Site 211-002), 419 Wakara Way, Suite 207
Salt Lake City, Utah, United States
LDS Hospital (Site 211-004), 8th Ave. C Street
Salt Lake City, Utah, United States
University of Virginia Health Systems (Site 301-021), 1215 Lee Street
Charlottesville, Virginia, 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
West Virginia University (Site 301-023), One Medical Center Drive
Morgantown, West Virginia, United States
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
Bispebjerg Hospital (Site 625-013), Bispebjerg Bakke 23
Copenhagen, , 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
Wojewódzki Szpital Zakazny (Site 625-302), Wolska 37
Warsaw, , Poland
Tan Tock Seng Hospital (Site 612-201), National Centre for Infectious Diseases (NCID), 11 Jalan Tan Tock Seng
Singapore, , Singapore
Hospital Universitari Germans Trias i Pujol (Site 626-003), Infectious Disease Unit, Second Floor, Building Maternal, Road Canyet s/n
Badalona, Barcelona, Spain
Hospital Universitari Arnau de Vilanova (Site 626-035), Av. Alcalde Rovira Roure 80
Lleida, Leida, Spain
Hospital Del Mar (Site 626-025), Paseo Maritimo 25-29
Barcelona, , Spain
Hospital Universitari Vall d'Hebron (Site 626-033), Passeig de la Vall d'Hebron 119-129
Barcelona, , Spain
Hospital Clínic de Barcelona (Site 626-004), Carrer de Villaroel 170
Barcelona, , Spain
Hospital Universitario de Bellvitge (Site 626-034), Carrer de la Feixa Llarga, s/n
Barcelona, , Spain
Hospital General Universitario Gregorio Marañón (Site 626-001), Dr. Esquerdo, 46
Madrid, , Spain
Hospital Clínico San Carlos (Site 626-017), Enfermedades infecciosas, C/Martin Lagos CN
Madrid, , Spain
UCICEC (Clinical Trial Unit) Hospital Universitario La Paz (Site 626-012), Paseo de la Castellana 261, 2a planta Hospital Maternal
Madrid, , Spain
University Hospital Zurich (Site 621-201), Department of Infectious Diseases and Hospital Epidemiology, Raemistrasse 100
Zurich, Canton of Zurich, Switzerland
MRC/UVRI and LSHTM Uganda Research Unit (Site 634-601), Entebbe Regional Referral Hospital
Entebbe, , Uganda
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
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
Royal Victoria Infirmary (Site 634-007), Queen Victoria Road
Newcastle upon Tyne, Northumbria, United Kingdom
Royal Free Hospital (Site 634-006), Pond Street, Hampstead
London, , United Kingdom
Guy's and St. Thomas' NHS Foundation Trust (Site 634-011)
London, , United Kingdom
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol: Trial H2 Protocol
Document Type: Study Protocol: Master Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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014/ACTIV-3/H2
Identifier Type: -
Identifier Source: org_study_id