Ignite Creation Date:
2024-05-06 @ 3:18 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04584710
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2021-02-09
First Post:
2020-10-08
Brief Title:
A Phase 2 Study of RTB101 as COVID-19 Post-Exposure Prophylaxis in Older Adults
Sponsor:
Restorbio Inc
Organization:
Restorbio Inc
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Phase 2a Study of RTB101 as COVID-19 Post-Exposure Prophylaxis in Adults Age 65 Years
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 3R01AG064802-02S1 | NIH | None | httpsreporternihgovquickSearch3R01AG064802-02S1 |