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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
≥ 2 symptoms of acute COVID-19 infection as determined by the investigator from the symptoms listed on the COVID-19 symptoms questionnaire present at randomization
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1-28
Awards & highlights

Study 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

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have at least two symptoms of COVID-19 infection at the time of screening, based on a questionnaire.

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)

Find a Location

Who is running the clinical trial?

Pardes Biosciences, Inc.Lead Sponsor
1 Previous Clinical Trials
130 Total Patients Enrolled
David Wilfret, MDStudy DirectorPardes Biosciences

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there ample medical facilities administering this clinical experiment in North America?

"Mercy Family Clinic in Houston, Texas, Infectious disease Consultants of the Treasure Coast in Sebastian, Mississippi and Safe Haven Clinical Research in Clinton California are some of the 40 sites that have opened recruiting for this trial."

Answered by AI

Is this investigation accommodating elderly individuals?

"To join this trial, potential participants must be within the appropriate age range of 18 to 64. For those under 18 and over 65 respectively, there are 137 and 899 other clinical trials available for them."

Answered by AI

Is recruitment still open for participation in this research experiment?

"Clinicaltrials.gov confirms that this medical study, which was launched on September 21st 2022, is actively seeking participants. The protocol has been recently revised as of November 11th 2022."

Answered by AI

To what extent should PBI-0451 be regarded as a health hazard?

"The safety of PBI-0451 has been gauged at a 2 on our Power scale, as this is currently an experimental Phase 2 trial with limited clinical data confirming its efficacy."

Answered by AI

Would I meet the prerequisites for participating in this experiment?

"This trial is recruiting 210 suitable patients who are currently suffering from COVID-19 and aged between 18 to 64. To be eligible, applicants must have had symptoms for no longer than 5 days before enrolment with a positive SARS-CoV-2 test within 24 hours of randomisation. Furthermore, it's mandatory that the patient has at least 2 acute symptoms as identified by the investigator via questionnaire; male participants must refrain from sperm donation during treatment and 90 days after completing study drug administration; receive primary vaccination series recommended by Centers for Disease Control and Prevention (CDC). Additionally, all female partakers need to pass a negative serum or urine"

Answered by AI

What is the current capacity of participants being admitted to this clinical experiment?

"The study sponsor, Pardes Biosciences, Inc., must recruit 210 eligible patients to run the trial. The process is taking place in various locations such as Mercy Family Clinic of Houston, Texas and Infectious disease Consultants of the Treasure Coast located in Sebastian, Mississippi."

Answered by AI

Who else is applying?

What state do they live in?
Florida
How old are they?
18 - 65
What site did they apply to?
Gonzalez M.D. & Aswad M.D. Health Care Services
What portion of applicants met pre-screening criteria?
Met criteria
~87 spots leftby Feb 2025