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Virus Therapy
Proof of Principle Study to Evaluate the Safety, PK, Viral Shedding and Efficacy of Pentarlandir™ UPPTA for Patients With Early COVID-19
Phase 2
Waitlist Available
Research Sponsored by SyneuRx International (Taiwan) Corp
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Summary
This trial is testing a new drug called Pentarlandir™ UPPTA in people who have mild COVID-19. The goal is to see if the drug can reduce the virus in their bodies and improve their symptoms. Participants will take the drug orally and be monitored for safety and effectiveness.
Eligible Conditions
- COVID-19
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 28 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Change from baseline in daily COVID-19-related symptom severity score through Day 28
Change from baseline in the patient's health status on a 7-category ordinal scale at up to Day 14
Number of days with limited COVID-19-associated symptoms in ePRO from Day 1-28 based on self- assessment using daily ePRO symptom diary.
+4 moreTrial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Pentarlandir™ UPPTA - Low DoseExperimental Treatment2 Interventions
Low dose of Pentarlandir™ UPPTA and placebo, q8h (over 3 hours postprandially)
Group II: Pentarlandir™ UPPTA - High DoseExperimental Treatment1 Intervention
High dose of Pentarlandir™ UPPTA, q8h (over 3 hours postprandially)
Group III: PlaceboPlacebo Group1 Intervention
Pacebo, q8h (over 3 hours postprandially)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Find a Location
Who is running the clinical trial?
SyneuRx International (Taiwan) CorpLead Sponsor
3 Previous Clinical Trials
627 Total Patients Enrolled