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Serine Protease Inhibitor
Part A: Upamostat 200 mg for Coronavirus
Phase 2 & 3
Waitlist Available
Research Sponsored by RedHill Biopharma Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 57 days
Awards & highlights
Study Summary
This study is evaluating whether a drug may help patients with a rare disease.
Eligible Conditions
- Coronavirus
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 57 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~57 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Part A - Determination of the safety and tolerability of two dose levels and selection of an upamostat dose for part B
Part B - Comparison between upamostat and placebo in time to sustained recovery from symptomatic illness.
Secondary outcome measures
Part A and at Interim Analysis in Part B - assessment of risk of hospitilization or death
Part B - Adverse events
Disease
+5 moreTrial Design
5Treatment groups
Experimental Treatment
Placebo Group
Group I: Part B: UpamostatExperimental Treatment1 Intervention
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.
Group II: Part A: Upamostat 400 mgExperimental Treatment1 Intervention
Each day participants will receive two 200 mg doses of upamostat, for a total of 14 days.
Group III: Part A: Upamostat 200 mgExperimental Treatment1 Intervention
Each day participants will receive a single 200 mg dose of upamostat along with a single matching placebo, for a total of 14 days.
Group IV: Part A: PlaceboPlacebo Group1 Intervention
Each day participants will receive two matching placebos, for a total of 14 days.
Group V: Part B: PlaceboPlacebo Group1 Intervention
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.
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Who is running the clinical trial?
RedHill Biopharma LimitedLead Sponsor
19 Previous Clinical Trials
2,760 Total Patients Enrolled
Terry Plasse, MDStudy DirectorRedHill Biopharma Limited
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who else is applying?
What state do they live in?
New York
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
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