Status:
TERMINATED
Upamostat, a Serine Protease Inhibitor, or Placebo for Treatment of COVID-19 Disease
Lead Sponsor:
RedHill Biopharma Limited
Conditions:
Covid19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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...
Detailed Description
Patients will be seen in a medical facility (ER or COVID-19 clinic) for initial evaluation. Consenting, diagnostically-confirmed COVID-19 patients not in need of hospitalization per investigator asses...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
February 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 28 2021
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT04723537
Start Date
February 16 2021
End Date
December 28 2021
Last Update
June 6 2024
Active Locations (17)
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1
Beautiful Minds Clinical Research
Cutler Bay, Florida, United States, 33157
2
Research in Miami Inc.
Hialeah, Florida, United States, 33013
3
Angels Clinical Research Institute
Miami, Florida, United States, 33122
4
South Florida Research Phase I-IV, Inc.
Miami Springs, Florida, United States, 33166