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Upamostat, a Serine Protease Inhibitor, or Placebo for Treatment of COVID-19 Disease

NCT04723537 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2024-06-06

Study results available
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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.

Conditions

  • Covid19

Interventions

DRUG

Part A: Upamostat 200 mg

1 capsule comprising 200 mg of upamostat and 1 capsule comprising matching placebo.

DRUG

Part A: Upamostat 400 mg

2 capsules, each capsule comprising 200 mg of upamostat

DRUG

Part A and B: Placebo

1 or 2 capsules, each capsule a matching placebo

DRUG

Part B: Upamostat 200 or 400 mg

Based on dose selection from Part A, "Part B Upamostat" will be EITHER a single 200 mg dose of upamostat OR two 200 mg doses of upamostat, for a total of 14 days.

Sponsors & Collaborators

  • RedHill Biopharma Limited

    lead INDUSTRY

Principal Investigators

  • Terry Plasse, MD · RedHill Biopharma Limited

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-16
Primary Completion
2021-12-28
Completion
2021-12-28
FDA Drug
Yes

Countries

  • United States
  • South Africa

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04723537 on ClinicalTrials.gov