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

Completed · Phase 3 · Has a placebo group

Conditions studied: COVID-19

In brief

This study looks at the safety and effectiveness of BRII-196/BRII-198 in treating COVID-19 in people who have been hospitalized with the infection. Participants in the study will be treated with either BRII-196/BRII-198 plus current standard of care (SOC), or with placebo plus current SOC. This is ACTIV-3/TICO Treatment Trial H3.

Key facts

Study ID

NCT05780424

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

353

Starts

2020-12-16

Expected to finish

2022-10-10

Last updated by the study team

2024-02-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Refer to the master protocol (NCT04501978)

You may not qualify if…

• 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 BRII-196/BRII-198 and 150 on placebo, patients on high-flow 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.

Where it is running

• 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
• Banner University Medical Center Tucson (Site 206-004), 1625 N. Campbell Avenue — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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