BRII-196/BRII-198 for Communicable Diseases

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Communicable Diseases+8 More
BRII-196/BRII-198 - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing multiple drugs from different companies to see if they can prevent COVID-19 progression to more serious symptoms.

Eligible Conditions
  • Communicable Diseases
  • Covid19

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Communicable Diseases

Study Objectives

5 Primary · 17 Secondary · Reporting Duration: Day 0 thru Week 72

Week 72
Cumulative incidence of death due to any cause or hospitalization due to any cause (Phases 2 and 3)
Day 14
Quantification of SARS-CoV-2 RNA (Phase 2)
Day 3
Level of SARS-CoV-2 RNA from NP swabs (Phase 3)
Quantification of SARS-CoV-2 RNA (Phase 3)
Day 28
COVID-19 symptom severity ranking (Phases 2 and 3)
Thru Day 14
AUC of SARS-CoV-2 RNA from site-collected NP swabs (Phase 2)
Level of SARS-CoV-2 RNA from NP swabs (Phase 2)
Thru Day 28
COVID-19 symptom duration (Phase 3)
Cumulative incidence of death due to any cause or hospitalization due to any cause (Phase 3)
Cumulative incidence of death from any cause or hospitalization due to any cause (Phase 2)
Cumulative incidence of death from any cause, or hospitalization due to any cause related to COVID-19 (Phase 3)
Duration of targeted clinical COVID-19 symptoms (Phases 2 and 3)
Oxygen saturation level (Phase 2)
Oxygen saturation level (Phases 2 and 3)
Proportion of participants with new adverse event (AE) ≥ Grade 3 (Phase 2)
Proportion of participants with new adverse event (AE) ≥ Grade 3 (Phase 3)
Proportion of participants with ≥1 worsening symptom of COVID-19 (Phases 2 and 3)
Time to self-reported return to usual health (a) (Phases 2 and 3)
Time to self-reported return to usual health (b) (Phases 2 and 3)
Thru Week 24
Incidence of new adverse event (AE) ≥ Grade 2 (Phases 2 and 3)
Incidence of new adverse event (AE) ≥ Grade 3 (Phases 2 and 3)
Up to Day 28
COVID-19 symptom duration (Phase 2)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Communicable Diseases

Trial Design

15 Treatment Groups

Casirivimab + Imdevimab (Phase III only)
1 of 15
Camostat
1 of 15
Bamlanivimab
1 of 15
Placebo (IV)
1 of 15
SAB-185 (Higher dose)
1 of 15
BMS 986414 + BMS 986413
1 of 15
AZD7442 (IV)
1 of 15
AZD7442 (IM)
1 of 15
BRII-196/BRII-198
1 of 15
SNG001
1 of 15
SAB-185 (Lower dose)
1 of 15
Placebo (SC injections)
1 of 15
Placebo (Inhaled solution)
1 of 15
Placebo (IM)
1 of 15
Placebo (oral tablets)
1 of 15
Active Control
Experimental Treatment
Non-Treatment Group

4044 Total Participants · 15 Treatment Groups

Primary Treatment: BRII-196/BRII-198 · Has Placebo Group · Phase 2 & 3

Camostat
Drug
Experimental Group · 1 Intervention: Camostat · Intervention Types: Drug
Bamlanivimab
Biological
Experimental Group · 1 Intervention: bamlanivimab · Intervention Types: Biological
Placebo (IV)
Drug
Experimental Group · 1 Intervention: Placebo (IV) · Intervention Types: Drug
SAB-185 (Higher dose)
Biological
Experimental Group · 1 Intervention: SAB-185 (10,240 Units/kg) · Intervention Types: Biological
BMS 986414 + BMS 986413
Biological
Experimental Group · 1 Intervention: BMS-986414 + BMS-986413 · Intervention Types: Biological
AZD7442 (IV)
Biological
Experimental Group · 1 Intervention: AZD7442 (IV) · Intervention Types: Biological
AZD7442 (IM)
Biological
Experimental Group · 1 Intervention: AZD7442 (IM) · Intervention Types: Biological
BRII-196/BRII-198
Biological
Experimental Group · 1 Intervention: BRII-196/BRII-198 · Intervention Types: Biological
SNG001
Drug
Experimental Group · 1 Intervention: SNG001 · Intervention Types: Drug
SAB-185 (Lower dose)
Biological
Experimental Group · 1 Intervention: SAB-185 (3,840 Units/kg) · Intervention Types: Biological
Placebo (SC injections)
Drug
PlaceboComparator Group · 1 Intervention: Placebo (SC injections) · Intervention Types: Drug
Placebo (Inhaled solution)
Drug
PlaceboComparator Group · 1 Intervention: Placebo (Inhaled solution) · Intervention Types: Drug
Casirivimab + Imdevimab (Phase III only)
Drug
ActiveComparator Group · 1 Intervention: CASIRIVIMAB + IMDEVIMAB · Intervention Types: Drug
Placebo (IM)
Drug
PlaceboComparator Group · 1 Intervention: Placebo (IM) · Intervention Types: Drug
Placebo (oral tablets)
Drug
PlaceboComparator Group · 1 Intervention: Placebo (oral tablet) · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo (IV)
2015
Completed Phase 3
~510
Interferon beta-1a
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: day 0 thru week 72

Who is running the clinical trial?

AstraZenecaIndustry Sponsor
3,956 Previous Clinical Trials
91,804,876 Total Patients Enrolled
9 Trials studying Communicable Diseases
11,866 Patients Enrolled for Communicable Diseases
SAb Biotherapeutics, Inc.Industry Sponsor
5 Previous Clinical Trials
176 Total Patients Enrolled
Synairgen Research Ltd.Industry Sponsor
5 Previous Clinical Trials
1,898 Total Patients Enrolled
Brii Biosciences LimitedIndustry Sponsor
7 Previous Clinical Trials
3,002 Total Patients Enrolled
AIDS Clinical Trials GroupNETWORK
89 Previous Clinical Trials
65,505 Total Patients Enrolled
5 Trials studying Communicable Diseases
827 Patients Enrolled for Communicable Diseases
Sagent PharmaceuticalsIndustry Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,128 Previous Clinical Trials
5,052,366 Total Patients Enrolled
242 Trials studying Communicable Diseases
244,517 Patients Enrolled for Communicable Diseases
Bristol-Myers SquibbIndustry Sponsor
2,481 Previous Clinical Trials
3,915,548 Total Patients Enrolled
14 Trials studying Communicable Diseases
3,479 Patients Enrolled for Communicable Diseases
Eli Lilly and CompanyIndustry Sponsor
2,453 Previous Clinical Trials
3,116,681 Total Patients Enrolled
1 Trials studying Communicable Diseases
847 Patients Enrolled for Communicable Diseases
David Smith, MD, MASStudy ChairUniversity of California, San Diego
2 Previous Clinical Trials
761 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Documentation of laboratory-confirmed SARS-CoV-2 infection, as determined by a molecular (nucleic acid) or antigen test from any respiratory tract specimen (e.g
The fever that you feel is called a subjective fever.
Having shortness of breath or difficulty breathing at rest or with activity can be a sign of a serious problem.
I have a sore throat.
The article discusses how body pain or muscle pain/aches affects people's lives
A headache is a pain in the head

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 10th, 2021

Last Reviewed: October 21st, 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?
Texas44.4%
Florida22.2%
California11.1%
Other22.2%
How old are they?
18 - 65100.0%
What site did they apply to?
University of California San Francisco (Site 1009), 995 Potrero Ave., Building 80, Ward 8416.7%
University of Florida Jacksonville (Site 1039), 655 West 8th Street16.7%
Orlando Immunology Center (Site 1045), 1707 North Mills Avenue16.7%
Other50.0%
What portion of applicants met pre-screening criteria?
Met criteria85.7%
Did not meet criteria14.3%
How many prior treatments have patients received?
0100.0%

How responsive is this trial?

Most responsive sites:
  1. University of California San Francisco (Site 1009), 995 Potrero Ave., Building 80, Ward 84: < 24 hours
Average response time
  • < 1 Day
Typically responds via
Email100.0%
References