A Randomized, Double-Blind, Placebo-Controlled Phase 2a Study of RTB101 as COVID-19 Post-Exposure Prophylaxis in Adults Age ≥65 Years
Overview
- Phase
- Phase 2
- Intervention
- RTB101
- Conditions
- Covid19
- Sponsor
- Restorbio Inc.
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- 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
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •Any subject who self-reports:
- •As a current smoker, or stopped smoking within the past 6 months.
- •As a previous smoker with a ≥10 pack year smoking history.
- •Has a household member who currently smokes in the house.
- •Subjects with a medical history of chronic obstructive pulmonary disease (COPD), emphysema or chronic bronchitis requiring active treatment with a prescription medication
- •The subject has already had symptoms consistent with COVID-19 at screening.
- •Subjects who require chronic supplemental oxygen therapy at screening.
- •Subjects with current evidence of an unstable medical disorder including an unstable respiratory disorder, gastrointestinal disorder (including Child-Pugh class B and C hepatic impairment), renal disorder or hematologic disorder (including active leukemia) for which they have had an exacerbation of symptoms within the past month, or are undergoing a change in treatment.
- •The following cardiac conditions:
- •Unstable angina pectoris
Arms & Interventions
10 mg daily RTB101
RTB101 TORC1 inhibitor
Intervention: RTB101
Placebo
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
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
Time Frame: Beginning of randomization through Week 2
The number of days from the date of receipt of a positive SARS-CoV-2 swab test result to the date of first dose of study drug in asymptomatic subjects 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
Secondary Outcomes
- To determine the feasibility of using an eDiary to assess study drug compliance in the study drug population(Beginning of randomization through Week 2)
- To determine the percentage of subjects treated with RTB101 as compared to placebo who die from any cause from first dose of study drug through Day 14 and 21(From time of first dose through Week 3)
- To determine the percentage of subjects treated with RTB101 as compared to placebo who develop symptomatic laboratory-confirmed COVID-19 from first dose through Day 14(From time of first dose through Week 2)
- To determine the percentage of subjects treated with RTB101 as compared to placebo who develop laboratory-confirmed COVID-19 from first dose through Day 14 and are subsequently hospitalized for any reason through Day 21(From time of first dose through Week 3)
- To determine the percent of subjects treated with RTB101 or placebo who have laboratory-confirmed SARS-CoV-2 infection regardless of symptoms from first dose of study drug through Days 7, 14, 21.(From time of first dose through Week 3)
- To determine the feasibility of using an eDiary to assess COVID-19 symptoms in the study population(From time of first dose through Week 3)
- To assess the incidence of treatment-emergent of AEs and SAEs in subjects assigned to RTB101 as compared to placebo(From time of first dose through Week 3)