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Protease Inhibitor

PBI-0451 (Pomotrelvir) for COVID-19

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
Awards & highlights

Summary

This trial is testing a new drug to see if it can help people with COVID-19 who are not in the hospital. The drug is designed to stop the virus from replicating.

Eligible Conditions
  • COVID-19
  • Coronavirus

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1-28
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1-28 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To evaluate the antiviral activity of PBI-0451 (Pomotrelvir)
Secondary outcome measures
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 outcome measures
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 more

Trial 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
~74 spots leftby Jul 2025
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