Back to resultsA Phase 1/2 Study to Assess Safety and Efficacy of BAT2020 in Hospitalized COVID-19 Patients
Primary Purpose
COVID-19
Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
BAT2020
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19
Eligibility Criteria
- 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.
Sites / Locations
- Snake River Research
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Low dose
Medium dose
High dose
Arm Description
Outcomes
Primary Outcome Measures
Incidence of adverse events (AEs)
SAE, TEAEs, mortality, those resulting in treatment discontinuation, and changes from baseline in safety laboratory assessments
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04432766
Brief Title
A Phase 1/2 Study to Assess Safety and Efficacy of BAT2020 in Hospitalized COVID-19 Patients
Official Title
A Phase 1/2, Multi-Center, Randomized Study to Assess Safety, Pharmacokinetics, Immunogenicity, and Efficacy of BAT2020 in Hospitalized Patients Infected With SARS-CoV-2 (COVID-19)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Withdrawn
Why Stopped
strategic decision
Study Start Date
October 20, 2020 (Anticipated)
Primary Completion Date
January 20, 2021 (Anticipated)
Study Completion Date
August 18, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bio-Thera Solutions
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low dose
Arm Type
Experimental
Arm Title
Medium dose
Arm Type
Experimental
Arm Title
High dose
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
BAT2020
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of adverse events (AEs)
Description
SAE, TEAEs, mortality, those resulting in treatment discontinuation, and changes from baseline in safety laboratory assessments
Time Frame
Day 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Snake River Research
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Phase 1/2 Study to Assess Safety and Efficacy of BAT2020 in Hospitalized COVID-19 Patients
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