Ignite Creation Date:
2024-05-06 @ 3:31 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04666441
Status:
COMPLETED
Last Update Posted:
2022-04-08
First Post:
2020-12-10
Brief Title:
COVID-19 Study Assessing the Virologic Efficacy of REGN10933REGN10987 Across Different Dose Regimens in Adult Outpatients With SARS-CoV-2 Infection
Sponsor:
Regeneron Pharmaceuticals
Organization:
Regeneron Pharmaceuticals
Study Overview
Official Title:
A Phase 2 Study to Assess the Virologic Efficacy of REGN10933REGN10987 Across Different Dose Regimens in Outpatients With SARS-CoV-2 Infection
Status:
COMPLETED
Status Verified Date:
2022-03
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 objective of the study is to assess the virologic efficacy of REGN10933REGN10987 across different intravenous and subcutaneous doses compared to placebo
The secondary objectives of the study are
To evaluate additional indicators of virologic efficacy of REGN10933REGN10987 compared to placebo
To evaluate the safety and tolerability of REGN10933REGN10987 compared to placebo
To assess the concentrations of REGN10933 and REGN10987 in serum over time
To assess the immunogenicity of REGN10933 and REGN10987
The secondary objectives of the study are
To evaluate additional indicators of virologic efficacy of REGN10933REGN10987 compared to placebo
To evaluate the safety and tolerability of REGN10933REGN10987 compared to placebo
To assess the concentrations of REGN10933 and REGN10987 in serum over time
To assess the immunogenicity of REGN10933 and REGN10987
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