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NCT04723537 · ClinicalTrials.gov registry record · Phase 2
Upamostat, a Serine Protease Inhibitor, or Placebo for Treatment of COVID-19 Disease
A Phase 2 study, sponsored by RedHill Biopharma Limited.
- Terminated
- Registry status
- Phase 2
- Development phase
- 61
- Enrollment target
NCT04723537: Clinical Trial Phase 2 study, sponsored by RedHill Biopharma Limited.
NCT04723537 is a Phase 2 study that was terminated before completion, run by RedHill Biopharma Limited. The registered enrollment target is 61 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (54% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04723537, a Phase 2 study, was terminated before completion, sponsored by RedHill Biopharma Limited.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 61 participants
- Enrollment target
Study Summary
A 2-part, multicenter, Phase 2/3, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of upamostat in adult patients with COVID-19 disease who do not require inpatient care.
Primary Outcome
This is a qualitative measure that takes into account safety and tolerability based on the relative incidence and severity (CTCAE v 5.0 criteria) of adverse events, both clinical and laboratory (SOC=investigations) in each active treatment group as compared to placebo. In addition, toxicities (i.e., adverse events considered at lease possible related to study medication) resulting in dose reductions or discontinuation of therapy will be tabulated and compared among treatment groups.
Interventions
- DRUG Part A: Upamostat 200 mg
- DRUG Part A: Upamostat 400 mg
- DRUG Part A and B: Placebo
- DRUG Part B: Upamostat 200 or 400 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2021-02-16 |
| Est. Completion | 2021-12-28 |
| Phase | Phase 2 |
Why NCT04723537 stopped before completion
NCT04723537 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (54% lower).
The record links to 0 conditions, and to 4 interventions - of which Part A: Upamostat 200 mg is the first listed.
NCT04723537 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04723537 about?
NCT04723537 is a clinical study titled "Upamostat, a Serine Protease Inhibitor, or Placebo for Treatment of COVID-19 Disease". A 2-part, multicenter, Phase 2/3, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of upamostat in adult patients with COVID-19 disease who do not require inpatient care.
What is the current status of trial NCT04723537?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 61 participants. The study started on 2021-02-16. Estimated completion is 2021-12-28.
What interventions are being tested in trial NCT04723537?
The interventions under investigation include: Part A: Upamostat 200 mg (DRUG), Part A: Upamostat 400 mg (DRUG), Part A and B: Placebo (DRUG), Part B: Upamostat 200 or 400 mg (DRUG).
Who is sponsoring clinical trial NCT04723537?
This trial is sponsored by RedHill Biopharma Limited, which has 13 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04723537's enrollment target sits among peer trials
61 1026th of 2000 higher than 974 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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