Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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.

View on ClinicalTrials.gov ↗

View your shortlist →

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

FieldValue
Enrollment Target 61 participants
Start Date 2021-02-16
Est. Completion 2021-12-28
Phase Phase 2
RedHill Biopharma Limited

13 total trials

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.

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

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT04115306 · 61 participants · Phase 1

    Phase 1/1b/2 Study of Oral PMD-026 in Patients With Metastatic Breast Cancer

  • NCT05070845 · 61 participants · Phase 2

    Safety and Efficacy Study of PF-06835375 in Primary Immune Thrombocytopenia

  • NCT05187832 · 61 participants · Phase 1

    A Study of AND019 in Women With ER Positive HER2 Negative Advanced or Metastatic Breast Cancer

  • NCT05269316 · 61 participants · Phase 1

    Study to Evaluate IMP9064 as a Monotherapy or in Combination in Patients With Advanced Solid Tumors

Similar registry start date

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

  • NCT07125183 · started 2026-12 · Phase 2

    Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma

  • NCT07292298 · started 2026-11 · Phase 2

    Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates

  • NCT04263285 · started 2026-10 · NA

    Treatment of Depression Post-SCI

Source: ClinicalTrials.gov NCT04723537, the US trial registry maintained by the National Library of Medicine. NCT04723537 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.