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NCT04391309 · ClinicalTrials.gov registry record · Phase 2
COVID-19 and Anti-CD14 Treatment Trial
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Terminated
- Registry status
- Phase 2
- Development phase
- 49
- Enrollment target
NCT04391309: Clinical Trial Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT04391309 is a Phase 2 study that was terminated before completion, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 49 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04391309, a Phase 2 study, was terminated before completion, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 49 participants
- Enrollment target
Study 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.
Primary Outcome
The Primary Endpoint is time to clinical recovery, defined as the time from baseline to the first day that a subject is in categories 1, 2, or 3 on the Eight-Point Ordinal Scale through Day 28 (range 1 \[best\] to 8 \[worst\]). The Eight-Point Ordinal Scale is an assessment of the clinical status on each study day. The Scale is defined as follows: 1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities and/or requiring home oxygen 3. Hospitalized, not req
Interventions
- OTHER Placebo
- DRUG remdesivir
- BIOLOGICAL anti-CD14
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2021-04-12 |
| Est. Completion | 2022-02-04 |
| Phase | Phase 2 |
Why NCT04391309 stopped before completion
NCT04391309 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (63% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04391309 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04391309 about?
NCT04391309 is a clinical study titled "COVID-19 and Anti-CD14 Treatment Trial". 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 effic...
What is the current status of trial NCT04391309?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 49 participants. The study started on 2021-04-12. Estimated completion is 2022-02-04.
What interventions are being tested in trial NCT04391309?
The interventions under investigation include: Placebo (OTHER), remdesivir (DRUG), anti-CD14 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04391309?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04391309's enrollment target sits among peer trials
49 1261st of 2000 higher than 736 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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