BRII-196/BRII-198 for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial)

PHASE3CompletedINTERVENTIONAL
Enrollment

353

Participants

Timeline

Start Date

December 16, 2020

Primary Completion Date

June 8, 2021

Study Completion Date

October 10, 2022

Conditions
COVID-19
Interventions
BIOLOGICAL

BRII-196

BRII-196 is a fully human immunoglobulin G (IgG)-1 monoclonal antibody (mAb) derived from antibody P2C-1F11 that was isolated directly from human B cells of a convalescent COVID-19 patient.

BIOLOGICAL

BRII-198

BRII-198 is a fully human IgG-1 mAb derived from antibody P2B-1G5 that was isolated directly from human B cells of a convalescent COVID-19 patient.

BIOLOGICAL

Placebo

Commercially available 0.9% sodium chloride solution

BIOLOGICAL

Remdesivir

Antiviral agent

Trial Locations (107)

2100

Righospitalet (Site 625-006), Blegdamsvej 9,, Copenhagen Ø

2400

Bispebjerg Hospital (Site 625-013), Bispebjerg Bakke 23, Copenhagen

2650

Hvidovre University Hospital, Department of Infectious Diseases (Site 625-001), Kettegård allé 30, Hvidovre

2730

Herlev/Gentofte Hospital (Site 625-012), Medicinsk Afdeling, Herlev Ringvej 75, Herlev

3400

Nordsjællands Hospital (Site 625-009), Dyrehavevej 29, Hillerød

4000

Zealand University Hospital, Roskilde (Site 625-010), Sygehusvej 10, Roskilde

5000

Odense University Hospital (Site 625-004), Infektionsmedicinsk Forskningsenhed, J.B. Winsløwsgade 4, Odense

6000

Kolding Sygehus (Site 625-011), Medicinsk Afdeling, Sygehusvej 24, Kolding

8091

University Hospital Zurich (Site 621-201), Department of Infectious Diseases and Hospital Epidemiology, Raemistrasse 100, Zurich

8200

Aarhus Universitetshospital, Skejby (Site 625-002), Department of Infectious Diseases, Palle Juul-Hensens Boulevard 99, Aarhus N

9000

Aalborg Hospital (Site 625-005), Hobrovej 18, Aalborg

10029

Ichan School of Medicine at Mount Sinai (Site 301-012), One Gustave L. Levy Place, Box 1620, New York

10451

Lincoln Medical Center (New York Health and Hospitals/Lincoln) (Site 003-016), 234 E. 149th Street, The Bronx

10461

Montefiore Medical Center Weiler Hospital (Site 206-003), 1825 Eastchester Road, The Bronx

10467

Montefiore Medical Center Moses Hospital (Site 206-001), 111 E. 210th Street, The Bronx

15213

UPMC Magee-Womens Hospital (Site 209-003), 300 Halket Street, Pittsburgh

UPMC Presbyterian Hospital (Site 209-001), 200 Lothrop Street, Pittsburgh

15232

UPMC Shadyside Hospital (Site 209-005), 5230 Centre Avenue, Pittsburgh

20007

MedStar Georgetown University Hospital (Site 067-001), 3800 Reservoir Road NW, Washington D.C.

20422

Washington DC VA Medical Center (Site 009-004), 50 Irving Street NW, Washington D.C.

21201

University of Maryland Medical Center (Site 301-019), 22 South Greene Street, Baltimore

22903

University of Virginia Health Systems (Site 301-021), 1215 Lee Street, Charlottesville

24153

Salem VA Medical Center (Site 074-014), 1970 Roanoke Blvd., Salem

25198

Hospital Universitari Arnau de Vilanova (Site 626-035), Av. Alcalde Rovira Roure 80, Lleida

26506

West Virginia University (Site 301-023), One Medical Center Drive, Morgantown

27157

Wake Forest University Health Sciences (Site 210-001), Medical Center Blvd, Winston-Salem

27710

Duke University Hospital (Site 301-006), 2301 Erwin Road, Durham

28017

Hospital General Universitario Gregorio Marañón (Site 626-001), Dr. Esquerdo, 46, Madrid

28040

Hospital Clínico San Carlos (Site 626-017), Enfermedades infecciosas, C/Martin Lagos CN, Madrid

28046

UCICEC (Clinical Trial Unit) Hospital Universitario La Paz (Site 626-012), Paseo de la Castellana 261, 2a planta Hospital Maternal, Madrid

29425

MUSC Research Nexus Clinic (Site 210-002), 96 Jonathan Lucas St., CSB 214, Charleston

30322

Emory University (Site 301-008), The Emory Clinic, Bldg. A, Suite 2236, 1365 Clifton Rd., NE, Atlanta

33021

Memorial Healthcare System (Site 648-002), Memorial Regional Hospital, 3501 Johnson Street, Hollywood

33125

Miami VAMC (Site 074-003), 1201 NW 16 Street, Miami

33602

Hillsborough County Health Department, University of South Florida (Site 032-001), Tampa

33744

Bay Pines VAMC (Site 074-004), 10000 Bay Pines Blvd., Bldg. 100, Room 5B-104, Bay Pines

33756

Baycare Health System (Site 301-025), Morton Plant Hospital, 300 Pinellas Street, Clearwater

37212

VA TVHS Nashville Campus (Site 074-022), 1310 24th Avenue South, Nashville

37232

Vanderbilt University Medical Center (Site 212-001), 1211 Medical Center Drive, Nashville

39216

University of Mississippi Medical Center (Site 202-005), 2500 North State Street, Jackson

40536

University of Kentucky Hospital (Site 210-004), 1000 South Limestone St., Lexington

44111

Cleveland Clinic Fairview Hospital (Site 207-005), 18101 Lorain Avenue, Cleveland

44125

Cleveland Clinic Marymount Hospital (Site 207-006), 12300 McCraken Road, Garfield Heights

44195

Cleveland Clinic Foundation (Site 207-001), 9500 Euclid Avenue, Cleveland

45219

University of Cincinnati Medical Center (Site 207-003), 234 Goodman Ave., Cincinnati

46804

Lutheran Medical Group (Site 301-010), 7916 W. Jefferson Boulevard, Fort Wayne

48109

University of Michigan (Site 205-001), 1500 East Medical Center Drive, Ann Arbor

48202

Henry Ford Health System, Henry Ford Hospital (Site 014-001), 2799 W. Grand Blvd., Detroit

55407

Minneapolis Heart Institute Foundation (Site 301-026), Abbott Northwestern Hospital, 920 E 28th St. #100, Minneapolis

55415

Hennepin Healthcare (Site 027-001), 701 Park Avenue, Minneapolis

55417

Minneapolis VA Health Care System (Site 105-001), 1 Veterans Drive, Bldg 70, Minneapolis

63106

VA St. Louis Healthcare System (Site 074-027), 915 North Grand Blvd., Rm. C201, St Louis

66604

Cotton O'Neil Clinical Research Center (Site 080-030), Stormont Vail Health, 1500 SW 10th Avenue, Topeka

70121

Ochsner Clinic Foundation (Site 301-015), 1514 Jefferson Highway, New Orleans

75235

Parkland Health and Hospital Systems (Site 084-002), 5200 Harry Hines Blvd, Dallas

UT Southwestern Medical Center (Site 084-001), 1936 Amelia Court, 2nd Floor, Dallas

75246

Baylor, Scott and White Health (Site 301-003), Baylor University Medical Center, 3500 Gaston Ave., Dallas

75601

CHRISTUS Good Shepherd Medical Center (Site 080-031), 700 E. Marshall Ave., Longview

77030

Michael E. DeBakey Veterans Affairs Medical Center (MEDV AMC) (Site 074-006), 2002 Holcombe Blvd., Houston

Texas Heart Institute (Site 301-017), 6770 Bertner, MC4-266, Houston

78404

CHRISTUS Spohn Shoreline Hospital (Site 080-001), 600 Elizabeth Street, Corpus Christi

80045

University of Colorado Hospital (Site 204-001), 12605 E. 16th Avenue, Aurora

80204

Denver Public Health (Site 017-004), 660 Bannock St., MC2600 (Infectious Disease Clinic), Denver

80206

National Jewish Health / St. Joseph Hospital (Site 204-003), 1400 Jackson Street, Denver

84107

Intermountain Medical Center (Site 211-001), 5121 South Cottonwood Street, Murray

84108

University of Utah Hospital (Site 211-002), 419 Wakara Way, Suite 207, Salt Lake City

84143

LDS Hospital (Site 211-004), 8th Ave. C Street, Salt Lake City

85719

Banner University Medical Center Tucson (Site 206-004), 1625 N. Campbell Avenue, Tucson

85723

Southern Arizona VA Healthcare System (Site 074-009), 3601 S. 6th Ave., Tucson

90033

Keck Hospital of USC (Site 301-020), 1500 San Pablo Street, Los Angeles

90048

Cedars-Sinai Medical Center (Site 208-002), 8700 Beverly Blvd., Los Angeles

90095

Ronald Reagan UCLA Medical Center (Site 203-002), 757 Westwood Plaza, Los Angeles

90502

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center (Site 066-002), 1124 W. Carson Street, CDCRC Building, Torrance

90822

VA Long Beach Healthcare System (Site 074-026), 5901 East 7th Street (09/151-M2), Long Beach

92357

VA Loma Linda Healthcare System (Site 074-017), 11201 Benton Street, Loma Linda

92663

Hoag Memorial Hospital Presbyterian (Site 080-026), One Hoag Drive, Newport Beach

93701

Community Regional Medical Center (Site 203-005), 2823 Fresno Street, Fresno

94115

UCSF Medical Center at Mount Zion (Site 203-007), 1600 Divisadero St., San Francisco

94121

San Francisco VAMC (Site 074-002), 4150 Clement St., San Francisco

94143

UCSF Medical Center (Site 203-001), Moffitt-Long Hospital, 505 Parnassus Ave., San Francisco

94305

Stanford University Hospital & Clinics (Site 203-003), 300 Pasteur Dr., Stanford

98122

Swedish Hospital First Hill (Site 208-005), 747 Broadway, Seattle

308433

Tan Tock Seng Hospital (Site 612-201), National Centre for Infectious Diseases (NCID), 11 Jalan Tan Tock Seng, Singapore

32608-1197

North Florida/South Georgia Veterans Health System (Site 074-011), 1601 SW. Archer Road, Gainesville

02114

Massachusetts General Hospital (Site 202-002), 55 Fruit Street, Boston

02215

Beth Israel Deaconess Medical Center (Site 202-001), 330 Brookline Ave., Boston

01199

Baystate Medical Center (Site 201-001), 759 Chestnut Street, Springfield

03756

Dartmouth-Hitchcock Medical Center/Mary Hitchcock Memorial Hospital (Site 301-024), One Medical Center Drive, Lebanon

08103

Cooper University Hospital (Site 019-001), One Cooper Plaza, Camden

97239-3098

Oregon Health & Science University (Site 208-003), 3181 SW Sam Jackson Park Rd., Portland

02903

Rhode Island Hospital (Site 080-036), 593 Eddy Street, Providence

02906

The Miriam Hospital (Site 080-039), 164 Summit Ave., Providence

01-201

Wojewódzki Szpital Zakazny (Site 625-302), Wolska 37, Warsaw

08916

Hospital Universitari Germans Trias i Pujol (Site 626-003), Infectious Disease Unit, Second Floor, Building Maternal, Road Canyet s/n, Badalona

08003

Hospital Del Mar (Site 626-025), Paseo Maritimo 25-29, Barcelona

08035

Hospital Universitari Vall d'Hebron (Site 626-033), Passeig de la Vall d'Hebron 119-129, Barcelona

08036

Hospital Clínic de Barcelona (Site 626-004), Carrer de Villaroel 170, Barcelona

08907

Hospital Universitario de Bellvitge (Site 626-034), Carrer de la Feixa Llarga, s/n, Barcelona

Unknown

MRC/UVRI and LSHTM Uganda Research Unit (Site 634-601), Entebbe Regional Referral Hospital, Entebbe

Gulu Regional Referral Hospital (Site 634-603), Laroo Division, PO Box 160, Gulu

Makerere University Lung Institute (Site 634-604), New Mulago Hospital Complex, Mulago Hill, Kampala

St. Francis Hospital, Nsambya (Site 634-607), Nsambya Road Nsambya Hill, P.O. Box 7146, Kampala

Lira Regional Referral Hospital (Site 634-605), Lira

Masaka Regional Referral Hospital (Site 634-606), MRC/UVRI and LSHTM Uganda Research Unit, Plot 6 Circle Road, PO Box 556, Masaka

NE1 4LP

Royal Victoria Infirmary (Site 634-007), Queen Victoria Road, Newcastle upon Tyne

NW3 2QG

Royal Free Hospital (Site 634-006), Pond Street, Hampstead, London

SE1 7EH

Guy's and St. Thomas' NHS Foundation Trust (Site 634-011), London

All Listed Sponsors
collaborator

International Network for Strategic Initiatives in Global HIV Trials (INSIGHT)

NETWORK

collaborator

University of Copenhagen

OTHER

collaborator

Medical Research Council

OTHER_GOV

collaborator

Kirby Institute

OTHER_GOV

collaborator

Washington D.C. Veterans Affairs Medical Center

FED

collaborator

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

NETWORK

collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

collaborator

US Department of Veterans Affairs

FED

collaborator

Prevention and Early Treatment of Acute Lung Injury

OTHER

collaborator

Cardiothoracic Surgical Trials Network

OTHER

collaborator

Brii Biosciences Limited

INDUSTRY

collaborator

University of Minnesota

OTHER

lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT05780424 - BRII-196/BRII-198 for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial) | Biotech Hunter | Biotech Hunter