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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
60
University of Connecticut, UConn Center on Aging
Farmington, Connecticut, United States
Hebrew Senior Life, Marcus Institute for Aging Research
Roslindale, Massachusetts, United States
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
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
Time frame: Beginning of randomization through Week 2
To determine the feasibility of using an eDiary to assess study drug compliance in the study drug population
Study drug compliance determined from the number of capsules of study drug taken by the subject based on data reported in an eDiary
Time frame: Beginning of randomization through Week 2
To determine the feasibility of using an eDiary to assess study drug compliance in the study drug population
Study drug compliance determined from the number of capsules of study drug taken by the subject based on data from twice weekly phone calls
Time frame: Beginning of randomization through Week 2
To determine the feasibility of using an eDiary to assess study drug compliance in the study drug population
Study drug compliance determined from the number of capsules of study drug taken by the subject based on a pill count done by phone when subjects complete study drug treatment
Time frame: Beginning of randomization through Week 2
To determine the feasibility of using an eDiary to assess COVID-19 symptoms in the study population
Incidence and severity of COVID-19 symptoms based on data reported in an eDiary
Time frame: From time of first dose through Week 3
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To determine the feasibility of using an eDiary to assess COVID-19 symptoms in the study population
Incidence and severity of COVID-19 symptoms based on data from twice weekly phone calls
Time frame: 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
Safety and tolerability will be assessed by report of AE/SAEs from first dose of study drug through Week 3
Time frame: 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
The percentage of subjects who have SARS-CoV-2 detected on nasal or nasopharyngeal swab and who develop 2 or more concurrent symptoms of COVID-19 from first dose of study drug through Day 14
Time frame: From time of first dose 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
The percentage of subjects who die from any cause from first dose of study drug through Day 14 and 21
Time frame: From time of first dose through Week 3
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
The percentage of subjects who develop laboratory-confirmed COVID-19 from first dose of study drug through Day 14 and are subsequently hospitalized for any reason through Day 21
Time frame: 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.
The percentage of subjects who have SARS-CoV-2 detected on nasal or nasopharyngeal swab regardless of symptoms from first dose of study drug through Day 7, 14, and 21 among subjects who are not SARS-CoV-2 positive at screening or baseline
Time frame: From time of first dose through Week 3