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

Bio-Thera Solutions

Status and phase: Withdrawn; Phase 2; Phase 1

Conditions: COVID-19

Treatments: Drug: BAT2020

Study type: Interventional

Funder types: Industry

Identifiers

NCT04432766

BAT-2020-001-CR

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

0 participants in 3 patient groups

Low dose

Experimental group

Treatment:

Drug: BAT2020

Medium dose

Experimental group

Treatment:

Drug: BAT2020

High dose

Experimental group

Treatment:

Drug: BAT2020