drugset / Trial / NCT04432766

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

NCT04432766 ↗

Phase 1/2 Withdrawn Bio-Thera Solutions
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2020-10-20
Primary completion
2021-01-20
Completion
2021-08-18

Outcome

Outcome not reported

Stopped (Business): “strategic decision”

Drugs

EvaluationDrugModalityDoseRoute
Subject BAT2020 Unknown — —

Indications