A Phase 2 Study of RTB101 as COVID-19 Post-Exposure Prophylaxis in Older Adults
NCT04584710 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2021-02-09
Summary
The proposed trial will obtain preliminary data on the feasibility of studying RTB101 as compared to placebo for COVID-19 post-exposure prophylaxis in adults age ≥ 65 years to inform the design of a subsequent pivotal trial.
Conditions
- Covid19
Interventions
- DRUG
-
RTB101
Oral RTB101 10 mg hard gelatin capsule once daily for 2 weeks
- DRUG
-
Oral matching placebo once daily for 2 weeks
Sponsors & Collaborators
-
National Institute on Aging (NIA)
collaborator NIH -
Restorbio Inc.
lead INDUSTRY
Principal Investigators
-
Medical Monitor · Restorbio Inc.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-10-13
- Primary Completion
- 2021-02-28
- Completion
- 2021-02-28
- FDA Drug
- Yes
Countries
- United States
Study Locations
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