COVID-19
Conditions
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.
Interventions
DRUGBAT2020
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.
Sponsors
Bio-Thera Solutions
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or nonpregnant female adult ≥18 years of age at time of enrollment. 2. Patient (or legally authorized representative) provides informed consent prior to initiation of any study procedures. 3. Agrees to the collection of nasopharyngeal swabs for virology assessment. 4. 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. 5. Enrollment within 72 hours of hospital admission.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events (AEs) | Day 28 | SAE, TEAEs, mortality, those resulting in treatment discontinuation, and changes from baseline in safety laboratory assessments |
Countries
United States
Outcome results
None listed