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Protease Inhibitor
PBI-0451 (Pomotrelvir) for Coronavirus
Phase 2
Waitlist Available
Research Sponsored by Pardes Biosciences, Inc.
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 day 1-28
Summary
This trial tests a new antiviral medicine called PBI-0451 (Pomotrelvir) on adults with COVID-19 who have symptoms but are not hospitalized. The medicine aims to stop the virus from multiplying, helping patients recover faster.
Eligible Conditions
- Coronavirus
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1-28
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1-28
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
To evaluate the antiviral activity of PBI-0451 (Pomotrelvir)
Secondary study objectives
To evaluate clinical efficacy of PBI-0451(Pomotrelvir) versus placebo through study Day 28
To evaluate safety and tolerability of PBI-0451(Pomotrelvir)
To evaluate the effect of PBI-0451(Pomotrelvir) on SARS-CoV-2
Other study objectives
To evaluate SARS-CoV-2 resistance to PBI-0451(Pomotrelvir)
To evaluate SARS-CoV-2 resistant variant susceptibility to PBI-0451(Pomotrelvir)
To evaluate plasma concentrations of a dose of PBI-0451(Pomotrelvir) to determine AUC from an intensive PK substudy of up to 50 subjects
+4 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: PBI-0451 (Pomotrelvir)Experimental Treatment1 Intervention
PBI-0451(Pomotrelvir): 2 x 350 mg tablets administered orally twice daily (BID) (1400 mg/day) with food for 5 days (10 total doses)
Group II: PlaceboPlacebo Group1 Intervention
PBI-0451(Pomotrelvir): 2 x placebo to match PBI-0451(Pomotrelvir) tablets administered orally twice daily (BID) with food for 5 days (10 total doses)
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Who is running the clinical trial?
Pardes Biosciences, Inc.Lead Sponsor
1 Previous Clinical Trials
130 Total Patients Enrolled
David Wilfret, MDStudy DirectorPardes Biosciences
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