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Target of Rapamycin Complex 1 (TORC1) inhibitor
10 mg daily RTB101 for Coronavirus
Phase 2
Waitlist Available
Research Sponsored by Restorbio Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from time of first dose through week 3
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.
Eligible Conditions
- Coronavirus
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from time of first dose through week 3
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from time of first dose through week 3
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
To determine the length of time from date of receipt of a positive SARS-CoV2 test result to date of first dose of study drug in asymptomatic adults age ≥ 65 years
Secondary study objectives
To assess the incidence of treatment-emergent of AEs and SAEs in subjects assigned to RTB101 as compared to placebo
To determine the feasibility of using an eDiary to assess COVID-19 symptoms in the study population
To determine the feasibility of using an eDiary to assess study drug compliance in the study drug population
+4 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: 10 mg daily RTB101Experimental Treatment1 Intervention
RTB101
TORC1 inhibitor
Group II: PlaceboPlacebo Group1 Intervention
Placebo
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Who is running the clinical trial?
National Institute on Aging (NIA)NIH
1,788 Previous Clinical Trials
28,184,712 Total Patients Enrolled
Restorbio Inc.Lead Sponsor
4 Previous Clinical Trials
1,712 Total Patients Enrolled
Medical MonitorStudy DirectorRestorbio Inc.
1,675 Previous Clinical Trials
988,738 Total Patients Enrolled
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