A Phase 1/2 Study to Assess Safety and Efficacy of BAT2020 in Hospitalized COVID-19 Patients

Study Overview
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Brief Summary
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This is a randomized study to assess safety, pharmacokinetics, immunogenicity, and efficacy of BAT2020 in hospitalized patients infected with COVID-19. This study is composed of 2 Parts: a single ascending dose (Part 1) and single dose(s) tested in parallel with a double-blind, placebo-controlled design (Part 2). Patients also will receive best available standard of care (SOC) treatment. A data and safety monitoring board (DSMB) will be set up for the study.

Official Title
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A Phase 1/2, Multi-Center, Randomized Study to Assess Safety, Pharmacokinetics, Immunogenicity, and Efficacy of BAT2020 in Hospitalized Patients Infected With SARS-CoV-2 (COVID-19)

Conditions
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COVID-19

Intervention / Treatment
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* Drug: BAT2020


Participation Criteria
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Eligibility Criteria
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Male or nonpregnant female adult ≥18 years of age at time of enrollment. Patient (or legally authorized representative) provides informed consent prior to initiation of any study procedures. Agrees to the collection of nasopharyngeal swabs for virology assessment. Women of childbearing potential must agree to either abstinence or use at least 1 primary form of contraception at the time of screening and for 4 months after study drug dosing. Enrollment within 72 hours of hospital admission.

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low dose<br> | Drug: BAT2020<br>* After a cohort completes the study on Day 28, data on safety and tolerability for each cohort will be evaluated by the Safety Monitoring Committee (SMC). Administration of the next higher dose to a new dosing cohort will be permitted only if adequate safety and tolerability have been demonstrated. If encouraging clinical benefit is observed at a certain dose level, the study may proceed to a to Part 2 based on emerging data.<br>|
| Experimental: Medium dose<br> | Drug: BAT2020<br>* After a cohort completes the study on Day 28, data on safety and tolerability for each cohort will be evaluated by the Safety Monitoring Committee (SMC). Administration of the next higher dose to a new dosing cohort will be permitted only if adequate safety and tolerability have been demonstrated. If encouraging clinical benefit is observed at a certain dose level, the study may proceed to a to Part 2 based on emerging data.<br>|
| Experimental: High dose<br> | Drug: BAT2020<br>* After a cohort completes the study on Day 28, data on safety and tolerability for each cohort will be evaluated by the Safety Monitoring Committee (SMC). Administration of the next higher dose to a new dosing cohort will be permitted only if adequate safety and tolerability have been demonstrated. If encouraging clinical benefit is observed at a certain dose level, the study may proceed to a to Part 2 based on emerging data.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events (AEs) | SAE, TEAEs, mortality, those resulting in treatment discontinuation, and changes from baseline in safety laboratory assessments | Day 28 |