PBI-0451 for COVID-19

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Ormond Beach Clinical Research, Ormond Beach, FL
COVID-19
PBI-0451 - Drug
Eligibility
18 - 65
All Sexes
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Study Summary

This is a phase 2 double-blind, randomized study of PBI-0451 in nonhospitalized symptomatic adults with COVID-19. PBI-0451 is a new chemical entity and inhibitor of the main protease of coronaviruses, including the SARS-CoV-2 that causes COVID-19 disease. This study is designed to evaluate the antiviral activity, safety, and efficacy of orally administered PBI-0451 compared with placebo.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for COVID-19

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: Day 1-28

Day 1
To evaluate plasma concentrations of a dose of PBI-0451 to determine AUC from an intensive PK substudy of up to 50 subjects
To evaluate plasma concentrations of a dose of PBI-0451 to determine Cmax from an intensive PK substudy of up to 50 subjects
To evaluate plasma concentrations of a dose of PBI-0451 to determine Tmax from an intensive PK substudy of up to 50 subjects
Day 1-28
To evaluate SARS-CoV-2 resistance to PBI-0451
To evaluate SARS-CoV-2 resistant variant susceptibility to PBI-0451
To evaluate clinical efficacy of PBI-0451 versus placebo through study Day 28
To evaluate safety and tolerability of PBI-0451
To evaluate the effect of PBI-0451 on SARS-CoV-2
To evaluate the incidence of rebound SARS-CoV-2 infection
To evaluate the relationship between SARS-CoV-2 detection methods
Day 1-5
To evaluate PBI-0451 pharmacokinetics (PK)
Day 3
To evaluate the antiviral activity of PBI-0451

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for COVID-19

Trial Design

2 Treatment Groups

PBI-0451
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group

210 Total Participants · 2 Treatment Groups

Primary Treatment: PBI-0451 · Has Placebo Group · Phase 2

PBI-0451
Drug
Experimental Group · 1 Intervention: PBI-0451 · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PBI-0451
2021
Completed Phase 1
~130

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: day 1-28
Closest Location: Ormond Beach Clinical Research · Ormond Beach, FL
2018First Recorded Clinical Trial
1 TrialsResearching COVID-19
3 CompletedClinical Trials

Eligibility Criteria

Age 18 - 65 · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You can understand and sign a written informed consent form (ICF).
Subjects should be advised during informed consent that alternate therapies may be available outside of study participation.
You are male or female, and nonpregnant, nonlactating female subjects 18 to < 65 years of age.
You are male and/or female and/or your heterosexual partner must be of nonchildbearing potential or must use effective contraception from screening through 90 days after the last dose of study drug (see Appendix 3).
Female subjects must refrain from egg donation and in vitro fertilization during treatment and for ≥ 28 days after the last dose of study drug.
A normal 12-lead ECG evaluation without clinically significant abnormalities.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.