PBI-0451 (Pomotrelvir) Phase 2 Study in Nonhospitalized Symptomatic Adults With COVID-19

NCT05543707 | Terminated Phase 2 Results FDA Drug

• 2 other identifiers: PBI-0451-00022022-001195-33
• Study Type: interventional
• Target: 242
• Locations: 1 country
• Sites: 54

Brief Summary

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.

Conditions

COVID-19

Keywords

COVID; SARS-CoV-2; Coronavirus

Outcome Measures

Primary Outcomes (1)

• Virologic Efficacy of PBI-0451 (Pomotrelvir)

  The primary efficacy endpoint was the proportion of participants below LOD for infectious SARS-CoV-2 on Day 3 by IVA from MT nasal swabs for the mITTV analysis set.

  Day 3

Secondary Outcomes (4)

• Safety and Tolerability of PBI-0451(Pomotrelvir)

  Day 1-28

• Clinical Efficacy of PBI-0451(Pomotrelvir) Versus Placebo Through Study Day 28

  Day 1 - 28

• Effect of PBI-0451(Pomotrelvir) on SARS-CoV-2

  Day 1-28

• Clinical Efficacy of PBI-0451(Pomotrelvir) Versus Placebo Through Study Day 1-28

  Day 1-28

Other Outcomes (1)

• Incidence of Rebound SARS-CoV-2 Infection

  Day 1-28

Study Arms (2)

PBI-0451 (Pomotrelvir)

EXPERIMENTAL

PBI-0451(Pomotrelvir): 2 x 350 mg tablets administered orally twice daily (BID) (1400 mg/day) with food for 5 days (10 total doses)

Drug: PBI-0451 (Pomotrelvir)

Placebo

PLACEBO COMPARATOR

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)

Drug: Placebo

Interventions

PBI-0451 (Pomotrelvir) DRUG

2 × 350 mg tablets administered orally twice daily (BID) (1400 mg/day) with food for 5 days (10 total doses)

Also known as: Active

PBI-0451 (Pomotrelvir)

Placebo DRUG

2 × placebo to match PBI-0451(Pomotrelvir) tablets administered orally BID with food for 5 days (10 total doses)

Placebo

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pardes Biosciences, Inc.: lead

Study Sites (54)

Voyage Medical

Mesa, Arizona, 85210, United States

Location

Franco A Felizarta MD

Bakersfield, California, 93301-1692, United States

Location

Hope Clinical Research, LLC

Canoga Park, California, 91303, United States

Location

Biopharma Informatic, LLC

Encino, California, 91436, United States

Location

Ascada Research LLC

Fullerton, California, 92835-3424, United States

Location

Ark Clinical Research - Long Beach - Clinedge - PPDS

Long Beach, California, 92868, United States

Location

Valiance Clinical Research

Tarzana, California, 91356-6695, United States

Location

Allianz Research Institute - Colorado

Westminster, California, 92683-4454, United States

Location

TrueBlue Clinical Research- Brandon - HyperCore - PPDS

Brandon, Florida, 33511-4850, United States

Location

Beautiful Minds Clinical Research Center

Cutler Bay, Florida, 33157, United States

Location

Indago Research and Health Center

Hialeah, Florida, 33012-4174, United States

Location

Quality Research of South Florida

Hialeah, Florida, 33016-1811, United States

Location

Gonzalez M.D. & Aswad M.D. Health Care Services

Miami, Florida, 33125, United States

Location

Universal Medical and Research Center, LLC

Miami, Florida, 33126, United States

Location

CCM Clinical Research Group

Miami, Florida, 33133-4231, United States

Location

D&H National Research Centers

Miami, Florida, 33155-3262, United States

Location

Allied Biomedical Research Institute

Miami, Florida, 33155-4630, United States

Location

Florida International Medical Research

Miami, Florida, 33155, United States

Location

P&S Research, LLC

Miami, Florida, 33175, United States

Location

The Angel Medical Research Corporation

Miami Lakes, Florida, 33016-1641, United States

Location

South Florida Research

Miami Springs, Florida, 33166, United States

Location

EMINAT Research

Miramar, Florida, 33027, United States

Location

Combined Research Orlando Phase I-IV LLC

Orlando, Florida, 32803, United States

Location

Ormond Beach Clinical Research

Ormond Beach, Florida, 32174, United States

Location

CTMD Research, Inc. - Palm Springs - Hunt - PPDS

Palm Springs, Florida, 33406, United States

Location

IMIC Inc.

Palmetto Bay, Florida, 33157-5503, United States

Location

Infectious Disease Consultants of the Treasure Coast

Sebastian, Florida, 32958, United States

Location

Westchester General Hospital

South Miami, Florida, 33143-5045, United States

Location

DBC Research

Tamarac, Florida, 33321, United States

Location

Alliance Clinical Research-(Tampa)

Tampa, Florida, 33615-3816, United States

Location

Palm Beach Research - ClinEdge - PPDS

West Palm Beach, Florida, 33409, United States

Location

Agile Clinical Research Trials, LLC

Atlanta, Georgia, 30328, United States

Location

Centricity Research - Roswell - HyperCore - PPDS

Columbus, Georgia, 31904, United States

Location

Eagle Clinical Research

Chicago, Illinois, 60621-3116, United States

Location

Revival Research Corporation - Clinedge - PPDS

Sterling Heights, Michigan, 48312, United States

Location

Safe Haven Clinical Research

Clinton, Mississippi, 39056-5606, United States

Location

Mercury Street Medical Group

Butte, Montana, 59701-1652, United States

Location

Las Vegas Medical Research

Las Vegas, Nevada, 89128-0373, United States

Location

Research Carolina Elite

Denver, North Carolina, 28037-7929, United States

Location

WellNow Urgent Care Troy Urgent Care

Dayton, Ohio, 45424, United States

Location

STAT Research

Vandalia, Ohio, 45377, United States

Location

Clinovacare Medical Clinical Research Center

West Columbia, South Carolina, 29169, United States

Location

Veritas Health Care Group

West Columbia, South Carolina, 29169, United States

Location

Clinical Trials Center of Middle Tennessee

Franklin, Tennessee, 37067-5663, United States

Location

Central Texas Clinical Research

Austin, Texas, 78705, United States

Location

Zenos Clinical Research

Dallas, Texas, 75230-6895, United States

Location

Proactive Clinical Research, LLC Edinburg

Edinburg, Texas, 78539-4660, United States

Location

Care United Research, LLC

Forney, Texas, 75126-4174, United States

Location

Mercy Family Clinic

Houston, Texas, 75211, United States

Location

Xpress Trials

Houston, Texas, 77036-8280, United States

Location

Diversified Medical Practices, P.A.

Houston, Texas, 77084, United States

Location

Epic Clinical Research

Lewisville, Texas, 75057, United States

Location

VIP Trials

San Antonio, Texas, 78230, United States

Location

Suffolk Multispecialty Research

Suffolk, Virginia, 23435-3762, United States

Location

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Interventions

PBI-0451; Exercise

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Vice President, Quality
• Organization: Pardes Biosciences

jenna.tagliaferri@pardesbio.com

4042815163

Study Officials

• David Wilfret, MD

  Pardes Biosciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2022
• First Posted: September 16, 2022
• Study Start: September 21, 2022
• Primary Completion: January 27, 2023
• Study Completion: April 14, 2023
• Last Updated: December 11, 2024
• Results First Posted: December 11, 2024

Record last verified: 2024-08

Locations

US (54)