Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-30 @ 8:08 AM
Study NCT ID:
NCT05224856
Status:
WITHDRAWN
Last Update Posted:
2022-07-25
First Post:
2022-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Evaluate the Safety and Efficacy of Inhaled CT-P63 and CT-P66 Combination Therapy in Symptomatic Patients With COVID-19 Not Requiring Supplemental Oxygen
Sponsor:
Celltrion
Organization:
Study Overview
Official Title:
A Phase 3, Randomized, Parallel-group, Placebo-controlled, Double-blind Study to Evaluate the Efficacy and Safety of Inhaled CT-P63 and CT-P66 Combination Therapy in Symptomatic Patients With Coronavirus Disease 2019 (COVID-19) Not Requiring Supplemental Oxygen
Status:
WITHDRAWN
Status Verified Date:
2022-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The sponsor has decided to stop development of the inhaled CT-P63/66 combination therapy.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase 3 study to assess the efficacy about therapeutic effect of inhaled CT-P63 and CT-P66 combination therapy to symptomatic patiemts with COVID-19 and overall safety.
Detailed Description:
CT-P63 and CT-P66 are monoclonal antibodies targeted against SARS-CoV-2 spike receptor binding domain as a treatment for COVID-19 infection. CT-P63 and CT-P66 are currently being developed by the Sponsor as a potential treatment for COVID-19 infection. In this study, efficacy, safety, and virology of inhaled CT-P63 and CT-P66 will be evaluated in symptomatic patients with COVID-19 Infection.
Study Oversight
Has Oversight DMC:
None
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?: