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

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and from time of first dose through week 3 for reporting.

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

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