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

Sponsor
Pardes Biosciences, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05543707
Collaborator
(none)
210
Enrollment
5
Locations
2
Arms
9.6
Anticipated Duration (Months)
42
Patients Per Site
4.4
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
210 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 2 Double-blind, Randomized Study to Evaluate the Antiviral Activity, Safety, and Efficacy of Orally Administered PBI-0451 Compared With Placebo in Nonhospitalized Symptomatic Adults With COVID-19
Anticipated Study Start Date :
Sep 12, 2022
Anticipated Primary Completion Date :
Dec 12, 2022
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: PBI-0451

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

Drug: PBI-0451
2 × 350 mg tablets administered orally twice daily (BID) (1400 mg/day) with food for 5 days (10 total doses)
Other Names:
  • Active

    		•
    Placebo Comparator: Placebo

    PBI-0451: 2 x placebo to match PBI-0451 tablets administered orally twice daily (BID) with food for 5 days (10 total doses)

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

    Outcome Measures

    Primary Outcome Measures

    1. To evaluate the antiviral activity of PBI-0451 [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

    Secondary Outcome Measures

    1. To evaluate safety and tolerability of PBI-0451 [Day 1-28]

      Number of treatment-emergent adverse events (AEs), serious adverse events (SAEs), discontinuation due to AEs, and Grade 3 or 4 laboratory abnormalities

    2. To evaluate clinical efficacy of PBI-0451 versus placebo through study Day 28 [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

    3. To evaluate the effect of PBI-0451 on SARS-CoV-2 [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)

    Other Outcome Measures

    1. To evaluate SARS-CoV-2 resistance to PBI-0451 [Day 1-28]

      Sequence analysis of the SARS-CoV-2 main protease (Mpro) gene (nsp5) and Mpro cleavage sites

    2. To evaluate SARS-CoV-2 resistant variant susceptibility to PBI-0451 [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

    3. To evaluate the relationship between SARS-CoV-2 detection methods [Day 1-28]

      Correlation of SARS-CoV-2 detection by IVA, RAT, and qRT-PCR, as specified in the CVAP

    4. To evaluate the incidence of rebound SARS-CoV-2 infection [Day 1-28]

      Proportion of subjects with clinical and/or virologic rebound

    5. To evaluate PBI-0451 pharmacokinetics (PK) [Day 1-5]

      PBI-0451 plasma concentrations and pharmacokinetic parameters will be calculated from an intensive PK substudy of up to 50 subjects at timepoint intervals from pre-dose up to 12 hours post-dose on any study visit between Day 1 and Day 5; and PK concentrations from sparse sampling of all subjects on Day 1 and Day 5 will be used in a population PK analysis and reported separately

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 64 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    12. Females who are pregnant or breastfeeding

    13. Oxygen saturation of < 94% on room air

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 South Florida Research Miami Springs Florida United States 33166
    2 Gonzalez M.D. & Aswad M.D. Health Care Services Miami Florida United States 33125
    3 Florida International Medical Research Miami Florida United States 33155
    4 P&S Research, LLC Miami Florida United States 33175
    5 Ormond Beach Clinical Research Ormond Beach Florida United States 32174

    Sponsors and Collaborators

    • Pardes Biosciences, Inc.

    Investigators

    • Study Director: David Wilfret, MD, Pardes Biosciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Pardes Biosciences, Inc.
    ClinicalTrials.gov Identifier:
    NCT05543707
    Other Study ID Numbers:
    • PBI-0451-0002
    First Posted:
    Sep 16, 2022
    Last Update Posted:
    Sep 16, 2022
    Last Verified:
    Sep 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Pardes Biosciences, Inc.
    COVID
    SARS-CoV-2
    Coronavirus
    Additional relevant MeSH terms:
    COVID-19

    Study Results

    No Results Posted as of Sep 16, 2022