- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05543707
PBI-0451 (Pomotrelvir) Phase 2 Study in Nonhospitalized Symptomatic Adults With COVID-19
March 1, 2023 updated by: Pardes Biosciences, Inc.
A Phase 2 Double-blind, Randomized Study to Evaluate the Antiviral Activity, Safety, and Efficacy of Orally Administered PBI-0451(Pomotrelvir) Compared With Placebo in Nonhospitalized Symptomatic Adults With COVID-19
This is a phase 2 double-blind, randomized study of PBI-0451(Pomotrelvir) in nonhospitalized symptomatic adults with COVID-19.
PBI-0451(Pomotrelvir) 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(Pomotrelvir) compared with placebo.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
210
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Nikki Nepomuceno
- Phone Number: (858) 248-9088
- Email: nikki@pardesbio.com
Study Locations
-
-
Arizona
-
Mesa, Arizona, United States, 85210
- Voyage Medical
-
-
California
-
Bakersfield, California, United States, 93301-1692
- Franco A Felizarta MD
-
Canoga Park, California, United States, 91303
- Hope Clinical Research, LLC
-
Encino, California, United States, 91436
- Biopharma Informatic, LLC
-
Fullerton, California, United States, 92835-3424
- Ascada Research LLC
-
Long Beach, California, United States, 92868
- Ark Clinical Research - Long Beach - ClinEdge - PPDS
-
Tarzana, California, United States, 91356-6695
- Valiance Clinical Research
-
Westminster, California, United States, 92683-4454
- Allianz Research Institute - Colorado
-
-
Florida
-
Brandon, Florida, United States, 33511-4850
- TrueBlue Clinical Research- Brandon - HyperCore - PPDS
-
Cutler Bay, Florida, United States, 33157
- Beautiful Minds Clinical Research Center
-
Hialeah, Florida, United States, 33012-4174
- Indago Research and Health Center
-
Hialeah, Florida, United States, 33016-1811
- Quality Research of South Florida
-
Miami, Florida, United States, 33155-4630
- Allied Biomedical Research Institute
-
Miami, Florida, United States, 33155
- Florida International Medical Research
-
Miami, Florida, United States, 33175
- P&S Research, LLC
-
Miami, Florida, United States, 33126
- Universal Medical and Research Center, LLC
-
Miami, Florida, United States, 33125
- Gonzalez M.D. & Aswad M.D. Health Care Services
-
Miami, Florida, United States, 33133-4231
- CCM Clinical Research Group
-
Miami, Florida, United States, 33155-3262
- D&H National Research Centers
-
Miami Lakes, Florida, United States, 33016-1641
- The Angel Medical Research Corporation
-
Miami Springs, Florida, United States, 33166
- South Florida Research
-
Miramar, Florida, United States, 33027
- EMINAT Research
-
Orlando, Florida, United States, 32803
- Combined Research Orlando Phase I-IV LLC
-
Ormond Beach, Florida, United States, 32174
- Ormond Beach Clinical Research
-
Palm Springs, Florida, United States, 33406
- CTMD Research, Inc. - Palm Springs - Hunt - PPDS
-
Palmetto Bay, Florida, United States, 33157-5503
- IMIC Inc.
-
Sebastian, Florida, United States, 32958
- Infectious Disease Consultants of the Treasure Coast
-
South Miami, Florida, United States, 33143-5045
- Westchester General Hospital
-
Tamarac, Florida, United States, 33321
- DBC Research
-
Tampa, Florida, United States, 33615-3816
- Alliance Clinical Research-(Tampa)
-
West Palm Beach, Florida, United States, 33409
- Palm Beach Research - ClinEdge - PPDS
-
-
Georgia
-
Atlanta, Georgia, United States, 30328
- AGILE Clinical Research Trials, LLC
-
Columbus, Georgia, United States, 31904
- Centricity Research - Roswell - HyperCore - PPDS
-
-
Illinois
-
Chicago, Illinois, United States, 60621-3116
- Eagle Clinical Research
-
-
Michigan
-
Sterling Heights, Michigan, United States, 48312
- Revival Research Corporation - Clinedge - PPDS
-
-
Mississippi
-
Clinton, Mississippi, United States, 39056-5606
- Safe Haven Clinical Research
-
-
Montana
-
Butte, Montana, United States, 59701-1652
- Mercury Street Medical Group
-
-
Nevada
-
Las Vegas, Nevada, United States, 89128-0373
- Las Vegas Medical Research
-
-
North Carolina
-
Denver, North Carolina, United States, 28037-7929
- Research Carolina Elite
-
-
Ohio
-
Dayton, Ohio, United States, 45424
- WellNow Urgent Care Troy Urgent Care
-
Vandalia, Ohio, United States, 45377
- STAT Research
-
-
South Carolina
-
West Columbia, South Carolina, United States, 29169
- Clinovacare Medical Clinical Research Center
-
West Columbia, South Carolina, United States, 29169
- Veritas Health Care Group
-
-
Tennessee
-
Franklin, Tennessee, United States, 37067-5663
- Clinical Trials Center of Middle Tennessee
-
-
Texas
-
Austin, Texas, United States, 78705
- Central Texas Clinical Research
-
Dallas, Texas, United States, 75230-6895
- Zenos Clinical Research
-
Edinburg, Texas, United States, 78539-4660
- Proactive Clinical Research, LLC Edinburg
-
Forney, Texas, United States, 75126-4174
- Care United Research, LLC
-
Houston, Texas, United States, 75211
- Mercy Family Clinic
-
Houston, Texas, United States, 77036-8280
- Xpress Trials
-
Houston, Texas, United States, 77084
- Diversified Medical Practices, P.A.
-
Lewisville, Texas, United States, 75057
- Epic Clinical Research
-
San Antonio, Texas, United States, 78230
- VIP Trials
-
-
Virginia
-
Suffolk, Virginia, United States, 23435-3762
- Suffolk Multispecialty Research
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 64 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Can understand and sign a written informed consent form (ICF), which must be obtained prior to initiation of any study procedures.
- Onset of COVID-19 symptoms ≤ 5 days prior to randomization with a positive SARS-CoV-2 test ≤ 24 hours prior to randomization. Authorized NAAT or antigen tests that detect viral RNA or protein, respectively, are allowed.
- Received primary vaccination series as defined by Centers for Disease Control and Prevention (CDC). Subjects should be advised during informed consent that alternate therapies may be available outside of study participation.
- ≥ 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
- Male and nonpregnant, nonlactating female subjects 18 to < 65 years of age. Females must have a negative serum or urine pregnancy test at screening and prior to the first dose of study drug unless permanently sterile or in a postmenopausal state (see Appendix 3).
- Male and female subjects and/or their heterosexual partners must either 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
- Male subjects must refrain from sperm donation from screening through 90 days after the last dose of study drug
- Normal 12-lead electrocardiogram (ECG) evaluation without clinically significant abnormalities
- Able and willing to comply with all study requirements
Exclusion Criteria:
- Considered at high-risk of developing severe illness from COVID-19 defined as ≥ 1 CDC underlying medical condition associated with an increased risk of developing severe illness from COVID-19 (see Appendix 5)
- Unvaccinated against SARS-CoV-2 (defined as having not completed a primary vaccination series)
- Any SARS-CoV-2 vaccination within 3 month prior to randomization or anticipated to receive a SARS-CoV-2 vaccination (including a booster) during the 28-day study period
- Currently hospitalized or expected to require hospitalization for COVID-19 within 48 hours of randomization
- Currently being treated or expected to be treated for COVID-19 with monoclonal antibodies, convalescent serum, or direct-acting antiviral agents (all potential subjects should be informed of evolving treatment options during informed consent that alternate therapies may or may not be available to them outside of study participation)
- Any clinical condition or laboratory result considered by the investigator to indicate any unstable or poorly controlled underlying clinically significant medical condition(s), active disseminated infection (other than SARS-CoV-2), or other medical condition that could represent a risk to the subject, including increasing the likelihood of a safety event, affect subject compliance, or affect efficacy and/or safety data collected during the 28-day study period
- Known active liver disease, including nonalcoholic steatohepatitis/nonalcoholic fatty liver disease, chronic or active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, primary biliary cirrhosis, Child-Pugh Class B or C, chronic alcoholic liver disease, or acute liver failure
- Receiving dialysis or having known severe renal impairment (chronic kidney disease, Stage 4 or above)
- Unable or unwilling to comply with the protocol procedures
- Participating in another interventional study with an investigational compound or device, including those for COVID-19
- Known prior participation in this study or another study involving PBI-0451(Pomotrelvir)
- Females who are pregnant or breastfeeding
- Oxygen saturation of < 94% on room air
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PBI-0451 (Pomotrelvir)
PBI-0451(Pomotrelvir): 2 x 350 mg tablets administered orally twice daily (BID) (1400 mg/day) with food for 5 days (10 total doses)
|
2 × 350 mg tablets administered orally twice daily (BID) (1400 mg/day) with food for 5 days (10 total doses)
Other Names:
|
Placebo Comparator: Placebo
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)
|
2 × placebo to match PBI-0451(Pomotrelvir) tablets administered orally BID with food for 5 days (10 total doses)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To evaluate the antiviral activity of PBI-0451 (Pomotrelvir)
Time Frame: Day 3
|
Proportion of subjects below the limit of detection (LOD) for infectious SARS-CoV-2 on Day 3 of treatment by infectious virus assay (IVA) from mid-turbinate (MT) swabs
|
Day 3
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To evaluate safety and tolerability of PBI-0451(Pomotrelvir)
Time Frame: Day 1-28
|
Number of treatment-emergent adverse events (AEs), serious adverse events (SAEs), discontinuations due to AEs, and Grade 3 or 4 laboratory abnormalities
|
Day 1-28
|
To evaluate clinical efficacy of PBI-0451(Pomotrelvir) versus placebo through study Day 28
Time Frame: Day 1-28
|
Proportion of subjects with sustained symptom resolution through Day 28; time to sustained symptom resolution through Day 28; proportion of subjects with COVID-19 related hospitalization or death from any cause through Day 28; severity of targeted COVID-19 symptoms; number of COVID-19 related medical visits other than hospitalization, including acute/critical care visits through Day 28; number of days in any hospital unit for treatment of COVID-19
|
Day 1-28
|
To evaluate the effect of PBI-0451(Pomotrelvir) on SARS-CoV-2
Time Frame: Day 1-28
|
Presence of SARS-CoV-2 virus, viral RNA or viral antigen based on IVA, quantitative reverse transcriptase polymerase chain reaction (qRT-PCR), and rapid antigen test (RAT), as specified in the Clinical Virology Analysis Plan (CVAP)
|
Day 1-28
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To evaluate the relationship between SARS-CoV-2 detection methods
Time Frame: Day 1-28
|
Correlation of SARS-CoV-2 detection by IVA, RAT, and qRT-PCR, as specified in the CVAP
|
Day 1-28
|
To evaluate the incidence of rebound SARS-CoV-2 infection
Time Frame: Day 1-28
|
Proportion of subjects with clinical and/or virologic rebound
|
Day 1-28
|
To evaluate SARS-CoV-2 resistance to PBI-0451(Pomotrelvir)
Time Frame: Day 1-28
|
Sequence analysis of the SARS-CoV-2 main protease (Mpro) gene (nsp5) and Mpro cleavage sites
|
Day 1-28
|
To evaluate SARS-CoV-2 resistant variant susceptibility to PBI-0451(Pomotrelvir)
Time Frame: Day 1-28
|
Susceptibility analysis of SARS-CoV-2 variants with Mpro amino acid substitutions and variants with substitutions in Mpro cleavage sites in the SARS-CoV-2 polyprotein
|
Day 1-28
|
To evaluate plasma concentrations of a dose of PBI-0451(Pomotrelvir) to determine AUC from an intensive PK substudy of up to 50 subjects
Time Frame: Any study visit Day 1-5
|
Area under the plasma concentration-time profile from Time zero (predose) to end of dosing interval (up to 12 hours postdose)
|
Any study visit Day 1-5
|
To evaluate plasma concentrations of a dose of PBI-0451(Pomotrelvir) to determine Cmax from an intensive PK substudy of up to 50 subjects
Time Frame: Any study visit Day 1-5
|
Maximum concentration is estimated based on the plasma concentrations from Time zero (predose) to end of dosing interval (up to 12 hours postdose)
|
Any study visit Day 1-5
|
To evaluate plasma concentrations of a dose of PBI-0451(Pomotrelvir) to determine Tmax from an intensive PK substudy of up to 50 subjects
Time Frame: Any study visit Day 1-5
|
Tmax is the time to maximum concentration from Time zero (predose) to end of dosing interval (up to 12 hours postdose)
|
Any study visit Day 1-5
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: David Wilfret, MD, Pardes Biosciences
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 21, 2022
Primary Completion (Anticipated)
June 12, 2023
Study Completion (Anticipated)
July 2, 2023
Study Registration Dates
First Submitted
September 7, 2022
First Submitted That Met QC Criteria
September 14, 2022
First Posted (Actual)
September 16, 2022
Study Record Updates
Last Update Posted (Estimate)
March 3, 2023
Last Update Submitted That Met QC Criteria
March 1, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PBI-0451-0002
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on COVID-19
-
University of Roma La SapienzaQueen Mary University of London; Università degli studi di Roma Foro Italico; Bios Prevention SrlCompletedPost Acute Sequelae of COVID-19 | Post COVID-19 Condition | Long-COVID | Chronic COVID-19 SyndromeItaly
-
Yang I. PachankisActive, not recruitingCOVID-19 Respiratory Infection | COVID-19 Stress Syndrome | COVID-19 Vaccine Adverse Reaction | COVID-19-Associated Thromboembolism | COVID-19 Post-Intensive Care Syndrome | COVID-19-Associated StrokeChina
-
Massachusetts General HospitalRecruitingPost Acute COVID-19 Syndrome | Long COVID | Post Acute Sequelae of COVID-19 | Long COVID-19United States
-
Indonesia UniversityRecruitingPost-COVID-19 Syndrome | Long COVID | Post COVID-19 Condition | Post-COVID Syndrome | Long COVID-19Indonesia
-
Erasmus Medical CenterDa Vinci Clinic; HGC RijswijkNot yet recruitingPost-COVID-19 Syndrome | Long COVID | Long Covid19 | Post COVID-19 Condition | Post-COVID Syndrome | Post COVID-19 Condition, Unspecified | Post-COVID ConditionNetherlands
-
Dr. Soetomo General HospitalIndonesia-MoH; Universitas Airlangga; Biotis Pharmaceuticals, IndonesiaRecruitingCOVID-19 Pandemic | COVID-19 Vaccines | COVID-19 Virus DiseaseIndonesia
-
University of Witten/HerdeckeInstitut für Rehabilitationsforschung NorderneyCompletedPost-COVID-19 Syndrome | Long-COVID-19 SyndromeGermany
-
University Hospital, Ioannina1st Division of Internal Medicine, University Hospital of IoanninaRecruitingCOVID-19 Pneumonia | COVID-19 Respiratory Infection | COVID-19 Pandemic | COVID-19 Acute Respiratory Distress Syndrome | COVID-19-Associated Pneumonia | COVID 19 Associated Coagulopathy | COVID-19 (Coronavirus Disease 2019) | COVID-19-Associated ThromboembolismGreece
-
Jonathann Kuo, MDActive, not recruitingSARS-CoV2 Infection | Post-COVID-19 Syndrome | Dysautonomia | Post Acute COVID-19 Syndrome | Long COVID | Long Covid19 | COVID-19 Recurrent | Post-Acute COVID-19 | Post-Acute COVID-19 Infection | Post Acute Sequelae of COVID-19 | Dysautonomia Like Disorder | Dysautonomia Orthostatic Hypotension Syndrome | Post... and other conditionsUnited States
Clinical Trials on PBI-0451 (Pomotrelvir)
-
Pyramid BiosciencesCompletedFormulation Bridging and Food Effect in Healthy VolunteersUnited States
-
NYU Langone HealthCompletedBreast CancerUnited States
-
Sidney Kimmel Comprehensive Cancer Center at Johns...Not yet recruiting
-
Pyramid BiosciencesTerminatedSolid Tumor, Adult | Desmoplastic Small Round Cell Tumor | Brain Tumor, PrimaryFrance, United States, Spain, Hong Kong, United Kingdom, Australia, Singapore, Germany, Korea, Republic of, Italy, Denmark
-
Liminal BioSciences Ltd.TerminatedAlström SyndromeUnited Kingdom
-
Liminal BioSciences Ltd.CompletedDiabetes | Inflammation and FibrosisUnited Kingdom
-
Phoenix Biotechnology, IncUnknownPancreatic CancerUnited States
-
Pyramid BiosciencesCompletedFood Effect in Healthy VolunteersUnited States
-
M.D. Anderson Cancer CenterCompleted