A Safety and Efficacy Study of Human Monoclonal Antibodies, BRII-196 and BRII-198 for the Treatment of Patients With COVID-19

Study Overview
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Brief Summary
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This study is to evaluate the safety, efficacy and pharmacokinetics profile of human monoclonal antibodies, BRII-196 and BRII-198 compared with placebo in patients with COVID-19.

Official Title
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A Phase 2, Randomized, Single-blinded, Placebo-controlled Study to Evaluate the Safety and Efficacy of Human Monoclonal Antibodies, BRII-196 and BRII-198, Administered by Intravenous Infusion for the Treatment of COVID-19 Patients

Conditions
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COVID-19

Intervention / Treatment
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* Drug: BRII-196 and BRII-198
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject ≥ 18 years, signing the informed consent. SARS-CoV-2 infection by PCR ≤ 7 days One or more of COVID-19 related symptoms or measured fever present within 48 hours prior to study entry (subjects with mild-moderate COVID-19) Exclusion Criteria: Recurring COVID-19 patients. Subjects with any unstable conditions, a history of significant hypersensitivity, or known allergy to components of the investigational agent Receipt of convalescent COVID-19 plasma, SARS-CoV-2 mAb treatment, SARS-CoV-2 vaccine, or other investigational treatments prior to study entry.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BRII-196 and BRII-198 in adult subjects with severe COVID-19<br> | Drug: BRII-196 and BRII-198<br>* BRII-196 and BRII-198 given by intravenous administration<br>|
| Placebo Comparator: Placebo in adult subjects with severe COVID-19<br> | Drug: Placebo<br>* Placebo given by intravenous administration<br>|
| Experimental: BRII-196 and BRII-198 in adult subjects with mild-moderate COVID-19<br> | Drug: BRII-196 and BRII-198<br>* BRII-196 and BRII-198 given by intravenous administration<br>|
| Experimental: Placebo in adult subjects with mild-moderate COVID-19<br> | Drug: Placebo<br>* Placebo given by intravenous administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events (AEs) |  | Day 29 | 
| Incidence of serious adverse events (SAEs) |  | up to Day 29 | 
| Change from pre-dose baseline in RBC count |  | Day 29 | 
| Change from pre-dose baseline in WBC count |  | Day 29 | 
| Change from pre-dose baseline in Platelets count |  | Day 29 | 
| Change from pre-dose baseline in Hemoglobin result |  | Day 29 | 
| Change from pre-dose baseline in Creatine kinase result |  | Day 29 | 
| Change from pre-dose baseline in Alanine aminotransferase (ALT) result |  | Day 29 | 
| Time-weighted average changes in SARSCoV-2 RNA levels in nasopharyngeal swabs from baseline to Day 8 |  | Day 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of COVID-19 related symptoms through Day 29 among subjects with mild-moderate COVID-19 |  | up to Day 29 | 
| Proportion of subjects who have mild-moderate COVID-19 and develop severe COVID-19 after randomization |  | up to 72 weeks | 
| Assessment of PK parameters: maximum serum concentration observed (Cmax) |  | up to Day 85 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19 phase 2, monoclonal antibody