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

No results posted yet for this study

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

Placebo

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

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04584710 on ClinicalTrials.gov