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ClinicalTrials.gov·

A Phase 2 Study of RTB101 as COVID-19 Post-Exposure Prophylaxis in Older Adults - NCT04584710

TORC

    Secondary Outcome Measures

  1. To determine the feasibility of using an eDiary to assess study drug compliance in the study drug population [ Time Frame: Beginning of randomization through Week 2 ]

    Study drug compliance determined from the number of capsules of study drug taken by the subject based on data reported in an eDiary


  2. To determine the feasibility of using an eDiary to assess study drug compliance in the study drug population [ Time Frame: Beginning of randomization through Week 2 ]

    Study drug compliance determined from the number of capsules of study drug taken by the subject based on data from twice weekly phone calls


  3. To determine the feasibility of using an eDiary to assess study drug compliance in the study drug population [ Time Frame: Beginning of randomization through Week 2 ]

    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


  4. To determine the feasibility of using an eDiary to assess COVID-19 symptoms in the study population [ Time Frame: From time of first dose through Week 3 ]

    Incidence and severity of COVID-19 symptoms based on data reported in an eDiary


  5. To determine the feasibility of using an eDiary to assess COVID-19 symptoms in the study population [ Time Frame: From time of first dose through Week 3 ]

    Incidence and severity of COVID-19 symptoms based on data from twice weekly phone calls


  6. To assess the incidence of treatment-emergent of AEs and SAEs in subjects assigned to RTB101 as compared to placebo [ Time Frame: From time of first dose through Week 3 ]

    Safety and tolerability will be assessed by report of AE/SAEs from first dose of study drug through Week 3


  7. 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 [ Time Frame: From time of first dose through Week 2 ]

    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


  8. 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 [ Time Frame: From time of first dose through Week 3 ]

    The percentage of subjects who die from any cause from first dose of study drug through Day 14 and 21


  9. 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 [ Time Frame: From time of first dose through Week 3 ]

    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


  10. 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. [ Time Frame: From time of first dose through Week 3 ]

    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