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NCT04803227 · ClinicalTrials.gov registry record · Phase 1
Safety and Tolerability of Emricasan in Symptomatic Outpatients Diagnosed With Mild-COVID-19
A Phase 1 study, sponsored by Histogen.
- Terminated
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
NCT04803227: Clinical Trial Phase 1 study, sponsored by Histogen.
NCT04803227 is a Phase 1 study that was terminated before completion, run by Histogen. The registered enrollment target is 13 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04803227, a Phase 1 study, was terminated before completion, sponsored by Histogen.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
Study Summary
Treatments for COVID-19 are urgently needed. Emricasan (EMR) is a pan caspase inhibitor. Caspase-1 plays a role in a form of cell death called pyroptosis. EMR inhibits pyroptosis. The Investigators have shown that peripheral blood lymphocytes of COVID-19 patients overexpress caspase-1, providing evidence for pyroptosis. A recent European study corroborate the Investigators finding as they have shown evidence for the activation of the inflammasome in COVID-19.
Primary Outcome
Incidence rate of related treatment-emergent adverse events
Interventions
- OTHER Placebo
- DRUG Emricasan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2021-03-11 |
| Est. Completion | 2021-05-28 |
| Phase | Phase 1 |
Why NCT04803227 stopped before completion
NCT04803227 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04803227 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04803227 about?
NCT04803227 is a clinical study titled "Safety and Tolerability of Emricasan in Symptomatic Outpatients Diagnosed With Mild-COVID-19". Treatments for COVID-19 are urgently needed. Emricasan (EMR) is a pan caspase inhibitor. Caspase-1 plays a role in a form of cell death called pyroptosis. EMR inhibits pyroptosis. The Investigators have shown that peripheral blood lymphocytes of COVID-19 patients overexpress caspase-1, providing evi...
What is the current status of trial NCT04803227?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2021-03-11. Estimated completion is 2021-05-28.
What interventions are being tested in trial NCT04803227?
The interventions under investigation include: Placebo (OTHER), Emricasan (DRUG).
Who is sponsoring clinical trial NCT04803227?
This trial is sponsored by Histogen, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04803227's enrollment target sits among peer trials
13 1847th of 2000 higher than 149 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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