NCT04584710

A Phase 2 Study of RTB101 as COVID-19 Post-Exposure Prophylaxis in Older Adults

A Randomized, Double-Blind, Placebo-Controlled Phase 2a Study of RTB101 as COVID-19 Post-Exposure Prophylaxis in Adults Age ≥65 Years

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Restorbio Inc. · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The RTB101-211 study is a Randomized, Double-Blind, Placebo-Controlled Phase 2a Study of RTB101 as COVID-19 Post-Exposure Prophylaxis in Asymptomatic Adults Age ≥65 Years who: have SARS-CoV-2 detected on a surveillance nasal or nasopharyngeal swab OR live in the same house or apartment as someone who has laboratory-confirmed symptomatic COVID-19. The study is designed to obtain study feasibility data for RTB101 in an unbiased fashion and will inform the design of a subsequent pivotal trial.

Conditions

• Covid19

Interventions

Type	Name	Description
DRUG	RTB101	Oral RTB101 10 mg hard gelatin capsule once daily for 2 weeks
DRUG	Placebo	Oral matching placebo once daily for 2 weeks

Timeline

• Start date: 2020-10-13
• Primary completion: 2021-02-01
• Completion: 2021-02-01
• First posted: 2020-10-14
• Last updated: 2021-02-09

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study