drugset / Trial / NCT04391309
COVID-19 and Anti-CD14 Treatment Trial
Phase 2
Terminated
49 enrolled
National Institute of Allergy and Infectious Diseases (NIAID)
Implicit Bioscience · collabPPD Development, LP · collabUniversity of Washington · collabVanderbilt University Medical Center · collab
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2021-04-12
- Primary completion
- 2022-02-04
- Completion
- 2022-02-04
Outcome
Missed primary endpoint
Stopped (Enrollment): “Stopped to slow rate of enrollment”
registry analysis (superiority test); IC14 vs Placebo; p = 0.435; Log Rank NCT04391309 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | anti-CD14 | Monoclonal antibody | 2 mg/kg | Intravenous |
| Background | Remdesivir | Small molecule | 100 mg | Intravenous |