Ignite Creation Date:
2025-12-24 @ 1:51 PM
Ignite Modification Date:
2025-12-24 @ 1:51 PM
Study NCT ID:
NCT04426695
Status:
COMPLETED
Last Update Posted:
2023-01-27
First Post:
2020-06-08
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for Hospitalized Adult Patients With COVID-19
Sponsor:
Regeneron Pharmaceuticals
Organization:
Study Overview
Official Title:
A Master Protocol Assessing the Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for the Treatment of Hospitalized Patients With COVID-19
Status:
COMPLETED
Status Verified Date:
2023-01
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 primary objectives are:
Pooled Phase 3 (Cohort 1) and Phase 2 (Cohort 1A)
* To evaluate the virologic efficacy of REGN10933+REGN10987 compared to placebo in reducing viral load of SARS-CoV-2
* To evaluate the clinical efficacy of REGN10933+REGN10987 compared to placebo, as measured by death or mechanical ventilation
Phase 1/2 (Cohort 1)
* To exclude futility of REGN10933+REGN10987 compared to placebo, as measured by death or mechanical ventilation
* To evaluate the safety and tolerability of REGN10933+REGN10987 compared to placebo
Pooled Phase 3 (Cohort 1) and Phase 2 (Cohort 1A)
* To evaluate the virologic efficacy of REGN10933+REGN10987 compared to placebo in reducing viral load of SARS-CoV-2
* To evaluate the clinical efficacy of REGN10933+REGN10987 compared to placebo, as measured by death or mechanical ventilation
Phase 1/2 (Cohort 1)
* To exclude futility of REGN10933+REGN10987 compared to placebo, as measured by death or mechanical ventilation
* To evaluate the safety and tolerability of REGN10933+REGN10987 compared to placebo
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2020-002537-15 | EUDRACT_NUMBER | None | View |