Clinical Trials Directory

Trials / Terminated

TerminatedNCT04391309

COVID-19 and Anti-CD14 Treatment Trial

Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of the Effect of Anti-CD14 Treatment in Hospitalized Patients With COVID-19

Status
Terminated
Phase
Phase 2
Study type
Interventional
Enrollment
49 (actual)
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID) · NIH
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

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.

Conditions

Interventions

TypeNameDescription
BIOLOGICALanti-CD144 mg/kg on Day 1, 2 mg/kg on Days 2-4 administered intravenously (IV)
OTHERPlaceboPlacebo administered intravenously on Days 1-4
DRUGremdesivirRemdesivir administered intravenously for 5 days beginning with a 200 mg loading dose on Day 1, followed by 100 mg/day on Days 2-5.

Timeline

Start date
2021-04-12
Primary completion
2022-02-04
Completion
2022-02-04
First posted
2020-05-18
Last updated
2023-06-26
Results posted
2023-06-15

Locations

5 sites across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT04391309. Inclusion in this directory is not an endorsement.