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

• Status: Withdrawn
• Trial end date: 2021-08-18
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bio-Thera Solutions

Criteria

1. Male or nonpregnant female adult ≥18 years of age at time of enrollment.

2. Patient (or legally authorized representative) provides informed consent prior to initiation of any study procedures.

3. Agrees to the collection of nasopharyngeal swabs for virology assessment.

4. 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.

5. Enrollment within 72 hours of hospital admission.