A Study to Evaluate the Effect of RBT-9 on Progression of COVID-19 in High-Risk Individuals (The PREVENT Study)
NCT04364763 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42
Last updated 2023-03-29
Summary
The overall objective is to evaluate the efficacy, tolerability, and safety of a single dose of RBT-9 versus placebo in coronavirus disease 2019 (COVID-19) infection in non-critically ill adults who are at high risk of progression.
Conditions
Interventions
- DRUG
-
RBT-9 (90 mg)
Subjects will receive a single dose and study duration will be approximately 60 days per subject.
- DRUG
-
0.9% sodium chloride (normal saline)
Subjects will receive a single dose and study duration will be approximately 60 days per subject.
Sponsors & Collaborators
-
Renibus Therapeutics, Inc.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-08-05
- Primary Completion
- 2021-09-02
- Completion
- 2021-09-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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