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

NCT ID: NCT05543707

Last Updated: 2024-12-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 242 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-21
• Study Completion Date: 2023-04-14

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.

Detailed Description

Following randomization on Day 1, subjects will complete baseline assessments prior to receiving their first dose of study drug (PBI-0451 or placebo).

Randomization will be stratified as follows:

• SARS-CoV-2 positive direct test diagnosis ≤ 3 days (target 30%) versus > 3 days from first onset of COVID-19 symptom(s) ≤ 5 days prior to randomization
• Received primary vaccination series, alone versus any booster shots
• PK substudy participation versus nonparticipation Study drug will be taken with food, approximately 12 hours between doses, at approximately the same time for each BID dose for the remainder of the 5 days of treatment.All subjects will have additional safety and efficacy assessments during the 28-day study period. A follow-up visit (eg, telephone visit, virtual visit, clinic visit, etc. as convenient) will be conducted at Week 24 (± 20 days) after the last dose of study drug for all subjects. Information regarding ongoing or recurrent COVID-19 symptoms, survival status, pregnancy status (for female subjects of childbearing potential and female partners of male subjects), and any hospitalizations or acute/critical care visits (eg, non-admitted hospital or other care facility)that have occurred since the last study visit will be collected. A team of medically qualified individuals, including but not limited to, the Sponsor and the CRO Medical Monitors, and the Drug Safety Consultant are responsible for ongoing review of all AEs, concomitant medications, laboratory values (including virology), and vital signs (including pulse oximetry), worsening of symptoms (COVID-19 symptom questionnaire, including dyspnea), acute/critical care visits (eg, nonadmitted hospital or other care facility), and study drug discontinuations, at a minimum monthly basis throughout the study, per the Safety Monitoring Plan. Subjects who experience severe COVID-19 illness (defined in this study as sustained pulse oximetry <94%, a respiratory rate of >30 breaths/min, or dyspnea that requires medical attention) should discontinue study drug and be immediately referred by the Investigator to emergency care or treated by the Investigator for standard of care treatment of symptoms including, but not limited to, other antivirals, supplemental oxygen, corticosteroids, Janus kinase inhibitors, or interleukin-6 blockers, in accordance with the NIH Treatment Guidelines (NIH 2022). The subject should continue participation in the study, with study drug discontinued, for safety follow-up and clinical outcome of the medically attended visit.

Conditions

COVID-19

Keywords

COVID; SARS-CoV-2; Coronavirus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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)

Group Type: EXPERIMENTAL

PBI-0451 (Pomotrelvir)

Intervention Type: DRUG

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

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)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

PBI-0451 (Pomotrelvir)

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

Active

Eligibility Criteria

Inclusion Criteria

1. Can understand and sign a written informed consent form (ICF), which must be obtained prior to initiation of any study procedures.

2. 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.

3. 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.

4. ≥ 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

5. 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).

6. 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)

7. Female subjects must refrain from egg donation and in vitro fertilization during treatment and for ≥ 28 days after the last dose of study drug

8. Male subjects must refrain from sperm donation from screening through 90 days after the last dose of study drug

9. Normal 12-lead electrocardiogram (ECG) evaluation without clinically significant abnormalities

10. Able and willing to comply with all study requirements

Exclusion Criteria

1. 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)

2. Unvaccinated against SARS-CoV-2 (defined as having not completed a primary vaccination series)

3. 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

4. Currently hospitalized or expected to require hospitalization for COVID-19 within 48 hours of randomization

5. 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)

6. 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

7. 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

8. Receiving dialysis or having known severe renal impairment (chronic kidney disease, Stage 4 or above)

9. Unable or unwilling to comply with the protocol procedures

10. Participating in another interventional study with an investigational compound or device, including those for COVID-19

11. Known prior participation in this study or another study involving PBI-0451(Pomotrelvir)

12. Females who are pregnant or breastfeeding

13. Oxygen saturation of < 94% on room air

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pardes Biosciences, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Wilfret, MD

Role: STUDY_DIRECTOR

Pardes Biosciences

Locations

Voyage Medical

Mesa, Arizona, United States

Franco A Felizarta MD

Bakersfield, California, United States

Hope Clinical Research, LLC

Canoga Park, California, United States

Biopharma Informatic, LLC

Encino, California, United States

Ascada Research LLC

Fullerton, California, United States

Ark Clinical Research - Long Beach - Clinedge - PPDS

Long Beach, California, United States

Valiance Clinical Research

Tarzana, California, United States

Allianz Research Institute - Colorado

Westminster, California, United States

TrueBlue Clinical Research- Brandon - HyperCore - PPDS

Brandon, Florida, United States

Beautiful Minds Clinical Research Center

Cutler Bay, Florida, United States

Indago Research and Health Center

Hialeah, Florida, United States

Quality Research of South Florida

Hialeah, Florida, United States

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

Miami, Florida, United States

Universal Medical and Research Center, LLC

Miami, Florida, United States

CCM Clinical Research Group

Miami, Florida, United States

D&H National Research Centers

Miami, Florida, United States

Allied Biomedical Research Institute

Miami, Florida, United States

Florida International Medical Research

Miami, Florida, United States

P&S Research, LLC

Miami, Florida, United States

The Angel Medical Research Corporation

Miami Lakes, Florida, United States

South Florida Research

Miami Springs, Florida, United States

EMINAT Research

Miramar, Florida, United States

Combined Research Orlando Phase I-IV LLC

Orlando, Florida, United States

Ormond Beach Clinical Research

Ormond Beach, Florida, United States

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

Palm Springs, Florida, United States

IMIC Inc.

Palmetto Bay, Florida, United States

Infectious Disease Consultants of the Treasure Coast

Sebastian, Florida, United States

Westchester General Hospital

South Miami, Florida, United States

DBC Research

Tamarac, Florida, United States

Alliance Clinical Research-(Tampa)

Tampa, Florida, United States

Palm Beach Research - ClinEdge - PPDS

West Palm Beach, Florida, United States

Agile Clinical Research Trials, LLC

Atlanta, Georgia, United States

Centricity Research - Roswell - HyperCore - PPDS

Columbus, Georgia, United States

Eagle Clinical Research

Chicago, Illinois, United States

Revival Research Corporation - Clinedge - PPDS

Sterling Heights, Michigan, United States

Safe Haven Clinical Research

Clinton, Mississippi, United States

Mercury Street Medical Group

Butte, Montana, United States

Las Vegas Medical Research

Las Vegas, Nevada, United States

Research Carolina Elite

Denver, North Carolina, United States

WellNow Urgent Care Troy Urgent Care

Dayton, Ohio, United States

STAT Research

Vandalia, Ohio, United States

Clinovacare Medical Clinical Research Center

West Columbia, South Carolina, United States

Veritas Health Care Group

West Columbia, South Carolina, United States

Clinical Trials Center of Middle Tennessee

Franklin, Tennessee, United States

Central Texas Clinical Research

Austin, Texas, United States

Zenos Clinical Research

Dallas, Texas, United States

Proactive Clinical Research, LLC Edinburg

Edinburg, Texas, United States

Care United Research, LLC

Forney, Texas, United States

Mercy Family Clinic

Houston, Texas, United States

Xpress Trials

Houston, Texas, United States

Diversified Medical Practices, P.A.

Houston, Texas, United States

Epic Clinical Research

Lewisville, Texas, United States

VIP Trials

San Antonio, Texas, United States

Suffolk Multispecialty Research

Suffolk, Virginia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2022-001195-33

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

PBI-0451-0002

Identifier Type: -

Identifier Source: org_study_id