BRII-196/BRII-198 for COVID-19

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
COVID-19+6 More
BRII-196/BRII-198 - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial looks at the safety and effectiveness of different drugs in treating COVID-19 in hospitalized patients.

Eligible Conditions
  • COVID-19
  • Covid19

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 16 Secondary · Reporting Duration: 18 months

14 days
Oxygen
18 months
Oxygen
Day 1
Change in SARS-CoV-2 neutralizing antibody levels
Change in neutralizing antibody levels
Change in overall titers of antibodies
Days 1-7
Pulmonary+ ordinal outcome
Day 1
Pulmonary ordinal outcome
Thru 18 months
Composite of SAEs or death
Thru Day 0
Incidence of infusion reactions
Thru Day 28
Incidence of clinical organ failure
Thru Day 90
All-cause mortality
Composite of cardiovascular events and thromboembolic events
Composite of death or serious clinical COVID-19 related events
Composite of time to sustained recovery and mortality
Day 5
Composite of grade 3 and 4 clinical adverse events, serious adverse events (SAEs) or death
Up to Day 90
Days alive outside short-term acute care hospital
Time from randomization to sustained recovery

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

ACTIV-3 Drug plus SOC
1 of 2
Placebo plus SOC
1 of 2

Experimental Treatment

Non-Treatment Group

2753 Total Participants · 2 Treatment Groups

Primary Treatment: BRII-196/BRII-198 · Has Placebo Group · Phase 3

ACTIV-3 Drug plus SOCExperimental Group · 7 Interventions: BRII-196/BRII-198, Remdesivir, LY3819253, MP0420, VIR-7831, AZD7442, PF-07304814 · Intervention Types: Biological, Biological, Biological, Drug, Biological, Biological, Drug
Placebo plus SOCPlaceboComparator Group · 2 Interventions: Remdesivir, Placebo · Intervention Types: Biological, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Remdesivir
FDA approved
Bamlanivimab
FDA approved
Sotrovimab
FDA approved
Cilgavimab
Not yet FDA approved
PF-07304814
Not yet FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 18 months

Who is running the clinical trial?

University of CopenhagenOTHER
816 Previous Clinical Trials
12,275,532 Total Patients Enrolled
5 Trials studying COVID-19
1,369 Patients Enrolled for COVID-19
Molecular Partners AGIndustry Sponsor
11 Previous Clinical Trials
759 Total Patients Enrolled
3 Trials studying COVID-19
472 Patients Enrolled for COVID-19
US Department of Veterans AffairsFED
853 Previous Clinical Trials
468,118 Total Patients Enrolled
3 Trials studying COVID-19
1,133 Patients Enrolled for COVID-19
University of MinnesotaLead Sponsor
1,240 Previous Clinical Trials
1,458,719 Total Patients Enrolled
21 Trials studying COVID-19
21,405 Patients Enrolled for COVID-19
Cardiothoracic Surgical Trials Network (CTSN)UNKNOWN
2 Previous Clinical Trials
1,113 Total Patients Enrolled
2 Trials studying COVID-19
1,113 Patients Enrolled for COVID-19
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,577 Previous Clinical Trials
46,965,837 Total Patients Enrolled
13 Trials studying COVID-19
66,828 Patients Enrolled for COVID-19
AIDS Clinical Trials GroupNETWORK
89 Previous Clinical Trials
66,796 Total Patients Enrolled
3 Trials studying COVID-19
5,157 Patients Enrolled for COVID-19
Vir Biotechnology, Inc.Industry Sponsor
23 Previous Clinical Trials
10,177 Total Patients Enrolled
10 Trials studying COVID-19
5,892 Patients Enrolled for COVID-19
PfizerIndustry Sponsor
4,263 Previous Clinical Trials
7,105,390 Total Patients Enrolled
46 Trials studying COVID-19
121,949 Patients Enrolled for COVID-19
AstraZenecaIndustry Sponsor
3,960 Previous Clinical Trials
91,807,430 Total Patients Enrolled
36 Trials studying COVID-19
81,567,509 Patients Enrolled for COVID-19
National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,130 Previous Clinical Trials
4,931,311 Total Patients Enrolled
69 Trials studying COVID-19
286,707 Patients Enrolled for COVID-19
Prevention and Early Treatment of Acute Lung Injury (PETAL)UNKNOWN
2 Previous Clinical Trials
1,113 Total Patients Enrolled
2 Trials studying COVID-19
1,113 Patients Enrolled for COVID-19
Eli Lilly and CompanyIndustry Sponsor
2,455 Previous Clinical Trials
3,118,033 Total Patients Enrolled
12 Trials studying COVID-19
13,104 Patients Enrolled for COVID-19
GlaxoSmithKlineIndustry Sponsor
4,640 Previous Clinical Trials
7,942,684 Total Patients Enrolled
19 Trials studying COVID-19
21,275 Patients Enrolled for COVID-19
Brii Biosciences LimitedIndustry Sponsor
7 Previous Clinical Trials
4,293 Total Patients Enrolled
5 Trials studying COVID-19
4,137 Patients Enrolled for COVID-19
Washington D.C. Veterans Affairs Medical CenterFED
32 Previous Clinical Trials
13,104 Total Patients Enrolled
2 Trials studying COVID-19
1,113 Patients Enrolled for COVID-19
Kirby InstituteOTHER_GOV
98 Previous Clinical Trials
132,176 Total Patients Enrolled
5 Trials studying COVID-19
2,056 Patients Enrolled for COVID-19
Medical Research CouncilOTHER_GOV
298 Previous Clinical Trials
1,943,082 Total Patients Enrolled
5 Trials studying COVID-19
4,463 Patients Enrolled for COVID-19
International Network for Strategic Initiatives in Global HIV Trials (INSIGHT)NETWORK
6 Previous Clinical Trials
2,987 Total Patients Enrolled
4 Trials studying COVID-19
2,526 Patients Enrolled for COVID-19
Prof. James NeatonStudy ChairINSIGHT Statistical and Coordinating Centre, University of Minnesota
1 Previous Clinical Trials
473 Total Patients Enrolled
1 Trials studying COVID-19
473 Patients Enrolled for COVID-19
Prof. Jens LundgrenPrincipal InvestigatorINSIGHT Copenhagen International Coordinating Centre, Rigshospitalet, University of Copenhagen
1 Previous Clinical Trials
640 Total Patients Enrolled
1 Trials studying COVID-19
640 Patients Enrolled for COVID-19

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Symptoms of COVID-19 can include a fever, a dry cough, and difficulty breathing
The patient has tested positive for COVID-19 and is showing progressive symptoms that may be due to an ongoing COVID-19 infection.
People must be admitted to a hospital for acute medical care, not for public health or quarantine purposes.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 2nd, 2021

Last Reviewed: November 1st, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Texas50.0%
New York50.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Montefiore Medical Center Moses Hospital (Site 206-001), 111 E. 210th Street100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%
References