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NCT04858425 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of Niclosamide in Patients With COVID-19 With Gastrointestinal Infection
A Phase 2 study, sponsored by Entero Therapeutics.
- Terminated
- Registry status
- Phase 2
- Development phase
- 166
- Enrollment target
NCT04858425: Clinical Trial Phase 2 study, sponsored by Entero Therapeutics.
NCT04858425 is a Phase 2 study that was terminated before completion, run by Entero Therapeutics. The registered enrollment target is 166 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (25% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04858425, a Phase 2 study, was terminated before completion, sponsored by Entero Therapeutics.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 166 participants
- Enrollment target
Study Summary
This is a 2-part, 2-arm, Phase 2 , multicentre, randomized, double-blind, placebo-controlled study in adults with COVID-19 with gastrointestinal infection.
Primary Outcome
Serious adverse event (SAE) coded by System Organ Class (SOC) and Preferred Term (PT), using the Medical Dictionary for Regulatory Activities (MedDRA).
Interventions
- DRUG Placebo
- DRUG Niclosamide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 166 participants |
| Start Date | 2021-04-30 |
| Est. Completion | 2023-09-10 |
| Phase | Phase 2 |
Why NCT04858425 stopped before completion
NCT04858425 is an interventional study that assigns participants to a tested intervention. The registered 166 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (25% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04858425 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04858425 about?
NCT04858425 is a clinical study titled "Safety and Efficacy of Niclosamide in Patients With COVID-19 With Gastrointestinal Infection". This is a 2-part, 2-arm, Phase 2 , multicentre, randomized, double-blind, placebo-controlled study in adults with COVID-19 with gastrointestinal infection.
What is the current status of trial NCT04858425?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 166 participants. The study started on 2021-04-30. Estimated completion is 2023-09-10.
What interventions are being tested in trial NCT04858425?
The interventions under investigation include: Placebo (DRUG), Niclosamide (DRUG).
Who is sponsoring clinical trial NCT04858425?
This trial is sponsored by Entero Therapeutics, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04858425's enrollment target sits among peer trials
166 406th of 2000 higher than 1,591 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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