Ignite Creation Date:
2025-12-24 @ 5:09 PM
Ignite Modification Date:
2025-12-27 @ 4:16 PM
Study NCT ID:
NCT04642950
Status:
COMPLETED
Last Update Posted:
2024-07-19
First Post:
2020-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Phase II/III Study of Sargramostim
Sponsor:
Nobelpharma
Organization:
Study Overview
Official Title:
A Phase II/III Study of Sargramostim in Patients With Coronavirus Disease-2019 (COVID-19)
Status:
COMPLETED
Status Verified Date:
2021-11
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, placebo-controlled, double-blind, group comparison, multicenter study to evaluate the efficacy and safety of inhalation administration of sargramostim for 5 days, in principle (up to 10 days) as Add-on treatment to the standard treatment in COVID-19 patients.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
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?: