Upamostat, a Serine Protease Inhibitor, or Placebo for Treatment of COVID-19 Disease
Covid19
About this trial
This is an interventional treatment trial for Covid19
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- Beautiful Minds Clinical Research
- Research in Miami Inc.
- South Florida Research Phase I-IV, Inc.
- Angels Clinical Research Institute
- Great Lakes Research Group
- Henry Ford Hospital, emergency department
- Prime Global Research
- Montefiore Medical Center
- On-Site Clinical Solutions
- University Hospitals Cleveland
- Southwest Family Medicine Research
- Langeberg Medical Centre - Clinical Trials
- Roodepoort Medicross Clinical Trial Research Centre
- FCRN Clinical Trial Centre
- PJ Sebastian
- Global Clinical Trials PTY (LTD)
- WorthWhile Clinical Trials
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Part A: Upamostat 200 mg
Part A: Upamostat 400 mg
Part A: Placebo
Part B: Upamostat
Part B: Placebo
Each day participants will receive a single 200 mg dose of upamostat along with a single matching placebo, for a total of 14 days.
Each day participants will receive two 200 mg doses of upamostat, for a total of 14 days.
Each day participants will receive two matching placebos, for a total of 14 days.
Based on dose selected from Part A, each day participants will receive EITHER a single 200 mg dose of upamostat OR two 200 mg doses of upamostat, for a total of 14 days.
Based on dose selected from Part A, each day participants will receive EITHER a single matching placebo OR two matching placebos, for a total of 14 days.