Ignite Creation Date:
2024-05-06 @ 2:42 PM
Last Modification Date:
2024-10-26 @ 1:35 PM
Study NCT ID:
NCT04391309
Status:
TERMINATED
Last Update Posted:
2023-06-26
First Post:
2020-05-14
Brief Title:
COVID-19 and Anti-CD14 Treatment Trial
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Phase 2 Randomized Double-Blind Placebo-Controlled Study of the Effect of Anti-CD14 Treatment in Hospitalized Patients With COVID-19
Status:
TERMINATED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Stopped to slow rate of enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CaTT
Brief Summary:
This study aims to address the following objectives
1 To determine the efficacy of IC14 an anti-CD14 chimeric monoclonal antibody in patients hospitalized with respiratory disease and hypoxemia due to SARS-CoV-2 in terms of improving the time to resolution of disease
2 To determine the efficacy of IC14 in reducing the severity of respiratory disease in patients hospitalized with respiratory disease due to SARS-CoV-2
3 To determine the safety of IC14 in patients hospitalized with respiratory disease due to SARS-CoV-2
1 To determine the efficacy of IC14 an anti-CD14 chimeric monoclonal antibody in patients hospitalized with respiratory disease and hypoxemia due to SARS-CoV-2 in terms of improving the time to resolution of disease
2 To determine the efficacy of IC14 in reducing the severity of respiratory disease in patients hospitalized with respiratory disease due to SARS-CoV-2
3 To determine the safety of IC14 in patients hospitalized with respiratory disease due to SARS-CoV-2
Detailed Description:
This is a multicenter randomized double-blind placebo-controlled study of IC14 an antibody to CD14 in reducing the severity of respiratory disease in hospitalized Coronavirus Disease 2019 COVID-19 patients
Participants will be randomized to IC14 or matching placebo and followed for 60 days after randomization The study drug will be administered daily on Days 1-4 by intravenous infusion All participants will receive standard of care antiviral therapy with remdesivir
Participants will be randomized to IC14 or matching placebo and followed for 60 days after randomization The study drug will be administered daily on Days 1-4 by intravenous infusion All participants will receive standard of care antiviral therapy with remdesivir
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NIAID CRMS ID 38756 | OTHER | None | None |
| UM1AI109565 | NIH | DAIT NIAID | httpsreporternihgovquickSearchUM1AI109565 |