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

PHASE1/PHASE2WithdrawnINTERVENTIONAL
0
Timeline

Start Date

October 20, 2020

Primary Completion Date

January 20, 2021

Study Completion Date

August 18, 2021

Conditions
COVID-19
Interventions
DRUG

BAT2020

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.

Trial Locations (1)

83404

Snake River Research, Idaho Falls

Sponsors
All Listed Sponsors
lead

Bio-Thera Solutions

INDUSTRY