Trials / Terminated
TerminatedNCT04364763
A Study to Evaluate the Effect of RBT-9 on Progression of COVID-19 in High-Risk Individuals (The PREVENT Study)
A Phase 2, Randomized, Placebo-Controlled Study to Evaluate the Effect of RBT-9 on Progression of COVID-19 in High-Risk Individuals (The PREVENT Study)
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 42 (actual)
- Sponsor
- Renibus Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2020-08-05
- Primary completion
- 2021-09-02
- Completion
- 2021-09-30
- First posted
- 2020-04-28
- Last updated
- 2023-03-29
- Results posted
- 2023-03-29
Locations
5 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04364763. Inclusion in this directory is not an endorsement.