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

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ClinicalTrials.gov Identifier: NCT05543707
Recruitment Status : Recruiting
First Posted : September 16, 2022
Last Update Posted : December 21, 2022
Sponsor:
Information provided by (Responsible Party):
Pardes Biosciences, Inc.

Study Description
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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
COVID-19 Drug: PBI-0451 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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
Actual Study Start Date : September 21, 2022
Estimated Primary Completion Date : January 31, 2023
Estimated Study Completion Date : January 31, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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
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Primary Outcome Measures :
  1. To evaluate the antiviral activity of PBI-0451 [ 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


Secondary Outcome Measures :
  1. To evaluate safety and tolerability of PBI-0451 [ 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

  2. To evaluate clinical efficacy of PBI-0451 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

  3. To evaluate the effect of PBI-0451 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)


Other Outcome Measures:
  1. To evaluate SARS-CoV-2 resistance to PBI-0451 [ Time Frame: 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 [ 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

  3. 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

  4. To evaluate the incidence of rebound SARS-CoV-2 infection [ Time Frame: Day 1-28 ]
    Proportion of subjects with clinical and/or virologic rebound

  5. To evaluate plasma concentrations of a dose of PBI-0451 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)

  6. To evaluate plasma concentrations of a dose of PBI-0451 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)

  7. To evaluate plasma concentrations of a dose of PBI-0451 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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  12. Females who are pregnant or breastfeeding
  13. Oxygen saturation of < 94% on room air
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05543707


Contacts
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Contact: Nikki Nepomuceno (858) 248-9088 nikki@pardesbio.com

Locations
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Sponsors and Collaborators
Pardes Biosciences, Inc.
Investigators
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Study Director: David Wilfret, MD Pardes Biosciences
More Information
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Responsible Party: Pardes Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT05543707    
Other Study ID Numbers: PBI-0451-0002
First Posted: September 16, 2022    Key Record Dates
Last Update Posted: December 21, 2022
Last Verified: December 2022

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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:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases