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

Phase 1

Withdrawn

• Conditions: COVID-19
• Interventions: Drug: BAT2020

• Registration Number: NCT04432766
• Lead Sponsor: Bio-Thera Solutions

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-12
• Study First Submitted QC: 2020-06-15
• Study First Posted: 2020-06-16
• Study Start: 2020-10-20
• Primary Completion: 2021-01-20
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-06
• Last Update Posted: 2021-08-12
• Study Completion: 2021-08-18

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Medium dose	BAT2020	-
Low dose	BAT2020	-
High dose	BAT2020	-

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events (AEs)	Day 28	SAE, TEAEs, mortality, those resulting in treatment discontinuation, and changes from baseline in safety laboratory assessments

Trial Locations

Locations (1)

Snake River Research; 🇺🇸 Idaho Falls, Idaho, United States