Ignite Creation Date:
2024-05-06 @ 3:10 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04545060
Status:
COMPLETED
Last Update Posted:
2022-11-07
First Post:
2020-09-04
Brief Title:
VIR-7831 for the Early Treatment of COVID-19 in Outpatients
Sponsor:
Vir Biotechnology Inc
Organization:
Vir Biotechnology Inc
Study Overview
Official Title:
A Phase IIIII Randomized Multi-center Double-blind Placebo-controlled Study to Assess the Safety and Efficacy of Monoclonal Antibody VIR-7831 for the Early Treatment of Coronavirus Disease 2019 COVID-19 in Non-hospitalized Patients
Status:
COMPLETED
Status Verified Date:
2022-10
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:
COMET-ICE
Brief Summary:
This is a phase 23 study in which subjects with coronavirus disease 2019 COVID-19 will receive VIR-7831 or placebo and will be assessed for safety tolerability efficacy and pharmacokinetics
Detailed Description:
None
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 |
|---|---|---|---|
| GSK Study 214367 | OTHER | GlaxoSmithKline | None |