Status:
WITHDRAWN
A Phase 1/2 Study to Assess Safety and Efficacy of BAT2020 in Hospitalized COVID-19 Patients
Lead Sponsor:
Bio-Thera Solutions
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 asce...
Eligibility Criteria
Inclusion
- Male or nonpregnant female adult ≥18 years of age at time of enrollment.
- Patient (or legally authorized representative) provides informed consent prior to initiation of any study procedures.
- Agrees to the collection of nasopharyngeal swabs for virology assessment.
- 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.
- Enrollment within 72 hours of hospital admission.
Exclusion
Key Trial Info
Start Date :
October 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 18 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04432766
Start Date
October 20 2020
End Date
August 18 2021
Last Update
August 12 2021
Active Locations (1)
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1
Snake River Research
Idaho Falls, Idaho, United States, 83404