Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-30 @ 8:56 PM
Study NCT ID:
NCT04400058
Status:
COMPLETED
Last Update Posted:
2024-01-18
First Post:
2020-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Octagam 10% Therapy in COVID-19 Patients With Severe Disease Progression
Sponsor:
Octapharma
Organization:
Study Overview
Official Title:
Efficacy and Safety of Octagam 10% Therapy in COVID-19 Patients With Severe Disease Progression
Status:
COMPLETED
Status Verified Date:
2024-01
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:
This is a randomized, double-blind, placebo-controlled, multicenter, Phase 3 study to evaluate if high-dose Octagam 10% therapy can stabilize or improve clinical status in patients with severe Coronavirus disease
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?: