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Monoclonal Antibodies

Bamlanivimab 7000 mg (Phase 2) for Coronavirus

Q: To what purpose is BRII-196/BRII-198 often given to patients?

<p>BRII-196/BRII-198 is an effective treatment against <a href="https://www.withpower.com/clinical-trials/covid">covid</a>-19 for patients who are at a high risk of progressing to severe covid-19 and/or hospitalization, have mild to moderate covid-19, or test positive for sars-cov-2.</p>

Phase 2 & 3

Waitlist Available

Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 0 thru week 72

Awards & highlights

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

Coronavirus
Coronavirus Infection

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 0 thru week 72

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 0 thru week 72

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 0 thru week 72 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

COVID-19 Symptom Duration (Phase 2)

Cumulative Incidence of Death Due to Any Cause or Hospitalization Due to Any Cause (Phase 3)

Proportion of Participants With New Adverse Event (AE) ≥ Grade 3 (Phase 2)

+2 more

Secondary outcome measures

AUC of SARS-CoV-2 RNA From Site-collected NP Swabs (Phase 2)

COVID-19 Symptom Duration (Phase 3)

COVID-19 Symptom Severity Ranking (Phases 2 and 3)

+13 more

Trial Design

25Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: SNG001 (Phase 2)Experimental Treatment1 Intervention

Administered by inhalation

Group II: SAB-185 (low dose) (Phase 3) OMICRON populationExperimental Treatment1 Intervention

Administered by IV infusion The "Omicron subpopulation" enrolled under Protocol v.7 was defined as (1) all participants randomized under Protocol v.7 infected with the Omicron variant as identified on sequencing of NP sample obtained on day 0, plus (2) all participants randomized under Protocol v.7 on/after December 26, 2021, who do not have variant information available from sample obtained on day 0. Definitions were updated in Primary SAP v10.0 to be based on timing of emergence of Omicron variant within the study population as follows: Variant information from any sample (i.e. not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations. For participants without variant information, those randomized under Protocol v7 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.

Group III: SAB-185 (low dose) (Phase 3) Non-OMICRON populationExperimental Treatment1 Intervention

Administered by IV infusion. The "Non-Omicron subpopulation" enrolled under Protocol Version 7 was defined as all participants enrolled under Protocol Version 7 excluding those in the "Omicron subpopulation." Omicron/Non-Omicron subpopulation definitions were updated in Version 10.0 of the Primary SAP to be based on the timing of emergence of the Omicron variant within the study population as follows: Variant information from any sample (i.e., not just from samples obtained on day 0) could be used to assign a participant to the Omicron or non-Omicron Subpopulations. For participants without variant information, those randomized under Protocol Version 7.0 on or after December 15, 2021 would be assigned to the Omicron Subpopulation, and those randomized on or before December 14, 2021 would be assigned to the Non-Omicron Subpopulation.

Group IV: SAB-185 (low dose) (Phase 2)Experimental Treatment1 Intervention

Administered by IV infusion

Group V: SAB-185 (high dose) (Phase 2)Experimental Treatment1 Intervention

Administered by IV infusion

Group VI: Camostat (Phase 2)Experimental Treatment1 Intervention

Administered as oral tablets

Group VII: Bamlanivimab 700mg (Phase 3)Experimental Treatment1 Intervention

Administered by IV infusion

Group VIII: Bamlanivimab 700mg (Phase 2)Experimental Treatment1 Intervention

Administered by IV infusion

Group IX: Bamlanivimab 7000 mg (Phase 2)Experimental Treatment1 Intervention

Administered by IV infusion.

Group X: BRII-196+BRII-198 (Pooled Phase 2/3)Experimental Treatment1 Intervention

Administered by IV infusion

Group XI: BMS 986414+BMS 986413 (Phase 2)Experimental Treatment1 Intervention

Administered as subcutaneous (SC) injections

Group XII: AZD7442 (IV) (Phase 2)Experimental Treatment1 Intervention

Administered by IV infusion

Group XIII: AZD7442 (IM) (Phase 2)Experimental Treatment1 Intervention

Administered by IM injection

Group XIV: Casirivimab and Imdevimab (Phase 3) Non-OMICRON populationActive Control1 Intervention

Group XV: Casirivimab and Imdevimab (Phase 3) OMICRON populationActive Control1 Intervention

Group XVI: Bamlanivimab 7000mg Placebo (Phase 2)Placebo Group1 Intervention

Administered by IV infusion

Group XVII: AZD7442 (IV) Pooled Placebo (Phase 2)Placebo Group1 Intervention

Administered by IV infusion; shared placebo includes AZD7442 (IM) placebo and placebo from other comparator arms in the study.

Group XVIII: BMS 986414+BMS 986413 Pooled Placebo (Phase 2)Placebo Group1 Intervention

Administered as subcutaneous (SC) injections; shared placebo includes placebo from other comparator arms in the study.

Group XIX: BRII-196+BRII-198 Placebo (Pooled Phase 2/3)Placebo Group1 Intervention

Administered by IV infusion

Group XX: Bamlanivimab 700mg Placebo (Phase 2)Placebo Group1 Intervention

Administered by IV infusion

Group XXI: SAB-185 (low dose) Pooled Placebo (Phase 2)Placebo Group1 Intervention

Administered by IV infusion; includes SAB-185 (high dose) placebo and placebo from other comparator arms in the study.

Group XXII: AZD7442 (IM) Pooled Placebo (Phase 2)Placebo Group1 Intervention

Administered by IM injection; shared placebo includes AZD7442 (IV) placebo and placebo from other comparator arms in the study.

Group XXIII: SNG001 Pooled Placebo (Phase 2)Placebo Group1 Intervention

Administered by inhalation; shared placebo includes placebo from other comparator arms in the study.

Group XXIV: Camostat Pooled Placebo (Phase 2)Placebo Group1 Intervention

Administered as oral tablets; shared placebo includes placebo from other comparator arms in the study.

Group XXV: SAB-185 (high dose) Pooled Placebo (Phase 2)Placebo Group1 Intervention

Administered by IV infusion; includes SAB-185 (low dose) placebo and placebo from other comparator arms in the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

bamlanivimab 700mg

2020

Completed Phase 3

~4050

bamlanivimab 7000mg

2020

Completed Phase 3

~4050

BMS-986414 + BMS-986413

2020

Completed Phase 3

~4050

SNG001

2020

Completed Phase 3

~4890

BRII-196+BRII-198

2020

Completed Phase 3

~4050

AZD7442 (IM)

2020

Completed Phase 3

~4050

Camostat

2021

Completed Phase 3

~4170

SAB-185 (3,840 Units/kg)

2020

Completed Phase 3

~4050

SAB-185 (10,240 Units/kg)

2020

Completed Phase 3

~4050

AZD7442 (IV)

2020

Completed Phase 3

~4050

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

AstraZenecaIndustry Sponsor

4,259 Previous Clinical Trials

288,589,858 Total Patients Enrolled

Eli Lilly and CompanyIndustry Sponsor

2,615 Previous Clinical Trials

3,197,014 Total Patients Enrolled

AIDS Clinical Trials GroupNETWORK

100 Previous Clinical Trials

69,643 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what purpose is BRII-196/BRII-198 often given to patients?

"BRII-196/BRII-198 is an effective treatment against covid-19 for patients who are at a high risk of progressing to severe covid-19 and/or hospitalization, have mild to moderate covid-19, or test positive for sars-cov-2."

Answered by AI

At how many different locations is this trial currently being conducted?

"Patients can enroll at the Allied Biomedical Research Institute (Site 1227), 7100 SW. 47th St., Ste. 220 in Miami, Florida, University of Illinois at Chicago (Site 1147), 835 South Wood Street in Chicago, Illinois, and The University of Pittsburgh (Site 1018), 3471 5th Ave. in Pittsburgh, Pennsylvania along with other locations 100 other locations."

Answered by AI

Have other researchers done anything similar to this experiment before?

"There are 21 ongoing clinical trials for BRII-196/BRII-198 in 65 countries and 613 cities. The first trial began in 2008 and completed Phase 2 drug approval with the help of 220 participants. Since then, there have been 141 additional studies completed."

Answered by AI

How many people with the condition are being treated in this clinical trial?

"Unfortunately, this study is no longer recruiting patients. The listing for this trial was first posted on August 19th 2020 and edited most recently on March 17th 2022. At the moment, there are 1157 other trials actively looking for patients with communicable diseases and 21 trials involving BRII-196/BRII-198 that are still admitting participants."

Answered by AI

Are there any other examples in the medical literature of BRII-196/BRII-198?

"Currently, there are 21 clinical trials studying BRII-196/BRII-198. 13 of those live trials are in Phase 3. While the many trials for BRII-196/BRII-198 originated in Bilbao, Vizcaya, they have since spread to 1889 locations around the world."

Answered by AI

Are there any individuals who still qualify to participate in this research?

"Presently, this clinical trial is not looking for new participants. The study was first posted on 8/19/2020 and was updated as recently as 3/17/2022. There are presently 1157 other clinical trials actively recruiting patients with communicable diseases and 21 studies for BRII-196/BRII-198 that need participants."

Answered by AI