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

Stopped early · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Covid19

In brief

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.

Key facts

Study ID

NCT04723537

Run by

RedHill Biopharma Limited

People needed

61

Starts

2021-02-16

Expected to finish

2021-12-28

Last updated by the study team

2024-06-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with symptomatic, diagnostically confirmed COVID-19, per RT-PCR or antigen assay of respiratory tract sample.
• Patient must have either become symptomatic or found positive by RT-PCR or antigen assay within 5 days, whichever is greater, of randomization.
• Patients must fill out a baseline questionnaire which is reviewed by study personnel to determine eligibility.
• Males and females ≥age 18 years.
• Oxygen saturation by pulse oximeter ≥92% on room air
• Negative urine or serum pregnancy test (if woman of childbearing potential).
• Females of childbearing potential and males with female partners of childbearing potential must agree to use acceptable contraceptive methods during the study and for at least two months after the last dose of study medication.
• Ability to complete the daily diary independently.
• The patient must give informed consent

You may not qualify if…

• Patient is in need of acute hospitalization per clinician assessment.
• Pregnant or nursing women.
• Unwillingness or inability to comply with procedures required in this protocol.
• Patient requires supplemental oxygen.
• Patient is currently receiving, has received within the past 7 days or is expected to receive during the course of the study remdesivir, or other specific antiviral or anticytokine therapy for COVID-19, other than therapeutic monoclonal antibodies allowed or approved in the region in which the patient lives, or systemic corticosteroid equivalent to ≥20 mg daily prednisone/3 mg dexamethasone daily.
• Patient is currently receiving or has received within 30 days prior to screening any other investigational agent for any indication, including approved agents given for investigational indications (e.g., anti-cytokine treatments).
• Patient is currently taking or is expected to start taking warfarin, apixaban (Eliquis), or rivaroxaban (Xarelto). Patients may be taking or start on study dabigatran (Pradaxa), standard or low molecular weight heparin.

Where it is running

• Beautiful Minds Clinical Research — Cutler Bay, Florida, United States
• Research in Miami Inc. — Hialeah, Florida, United States
• Angels Clinical Research Institute — Miami, Florida, United States
• South Florida Research Phase I-IV, Inc. — Miami Springs, Florida, United States
• Great Lakes Research Group — Bay City, Michigan, United States
• Henry Ford Hospital, emergency department — Detroit, Michigan, United States
• Prime Global Research — The Bronx, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States
• On-Site Clinical Solutions — Charlotte, North Carolina, United States
• University Hospitals Cleveland — Cleveland, Ohio, United States
• Southwest Family Medicine Research — Dallas, Texas, United States
• Langeberg Medical Centre - Clinical Trials — Kraaifontein, Cape Town, South Africa
• Roodepoort Medicross Clinical Trial Research Centre — Roodepoort, Gauteng, South Africa
• FCRN Clinical Trial Centre — Vereeniging, Gauteng, South Africa
• PJ Sebastian — KwaZulu, KwaZulu-Natal, South Africa
• Global Clinical Trials PTY (LTD) — Arcadia, Pretoria, South Africa
• WorthWhile Clinical Trials — Benoni, South Africa

Full record on ClinicalTrials.gov

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