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EPIC-HR: Study of Oral PF-07321332/Ritonavir Compared With Placebo in Nonhospitalized High Risk Adults With COVID-19

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ClinicalTrials.gov Identifier: NCT04960202
Recruitment Status : Recruiting
First Posted : July 13, 2021
Last Update Posted : December 2, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE July 10, 2021
First Posted Date  ICMJE July 13, 2021
Last Update Posted Date December 2, 2021
Actual Study Start Date  ICMJE July 16, 2021
Estimated Primary Completion Date December 9, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 10, 2021)
Proportion of participants with COVID-19 related hospitalization or death from any cause [ Time Frame: Day 1 through Day 28 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 10, 2021)
  • Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)of PF-07321332/ritonavir relative to placebo [ Time Frame: Day 1 through Day 34 ]
  • Incidence of Treatment-emergent Adverse Events (TEAEs) of PF-07321332/ritonavir relative to placebo of PF-07321332/ritonavir relative to placebo [ Time Frame: Day 1 through Day 34 ]
  • Duration of each targeted COVID-19 sign/symptom [ Time Frame: Day 1 through Day 28 ]
  • Severity of each targeted COVID-19 sign/symptom [ Time Frame: Day 1 through Day 28 ]
  • Proportion of participants with death (all cause) [ Time Frame: Day 1 through Week 24 ]
  • To determine the pharmacokinetics (PK) in plasma and whole blood of PF-07321332 in nonhospitalized symptomatic adult participants with COVID 19 who are at increased risk of progression to severe disease [ Time Frame: Day 1 through Day 5 ]
  • Viral titers measured by Reverse Transcription Polymerase Chain Reaction (RT-PCR) in nasal swabs [ Time Frame: Day 1 through Day 14 ]
  • Number of COVID-19 related medical visits other than hospitalization [ Time Frame: Day 1 through Day 34 ]
  • Number of days in hospital and intensive care unit for the treatment of COVID-19 [ Time Frame: Day 1 through Day 34 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE EPIC-HR: Study of Oral PF-07321332/Ritonavir Compared With Placebo in Nonhospitalized High Risk Adults With COVID-19
Official Title  ICMJE AN INTERVENTIONAL EFFICACY AND SAFETY, PHASE 2/3, DOUBLE-BLIND, 2-ARM STUDY TO INVESTIGATE ORALLY ADMINISTERED PF-07321332/RITONAVIR COMPARED WITH PLACEBO IN NONHOSPITALIZED SYMPTOMATIC ADULT PARTICIPANTS WITH COVID-19 WHO ARE AT INCREASED RISK OF PROGRESSING TO SEVERE ILLNESS
Brief Summary The purpose of this study is to determine whether PF-07321332/ritonavir is safe and effective for the treatment of adults who are ill with COVID-19 and do not need to be in the hospital, but are at an increased risk of developing severe illness. Throughout the study period, provision will be made to allow study visits to be conducted at a participant's home or another non-clinic location if available. The total study duration is up to 24 weeks.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Eligible participants with a confirmed diagnosis of SARS-CoV-2 infection will be randomized (1:1) to receive PF-07321332/ritonavir or placebo orally every 12 hours for 5 days (10 doses total).
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE COVID-19
Intervention  ICMJE
  • Drug: PF-07321332
    PF-07321332 (tablet)
  • Drug: Ritonavir
    Ritonavir (capsule)
  • Drug: Placebo
    Placebo (tablet or capsule)
Study Arms  ICMJE
  • Experimental: PF-07321332/ritonavir
    Orally administered PF-07321332+ritonavir
    Interventions:
    • Drug: PF-07321332
    • Drug: Ritonavir
  • Placebo Comparator: Placebo
    Orally administered placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 20, 2021)
3000
Original Estimated Enrollment  ICMJE
 (submitted: July 10, 2021)
2260
Estimated Study Completion Date  ICMJE April 21, 2022
Estimated Primary Completion Date December 9, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Confirmed SARS-CoV-2 infection within 5 days prior to randomization
  • Initial onset of COVID-19 signs/symptoms within 5 days prior to the day of randomization and at least 1 of the specified COVID-19 signs/symptoms present on the day of randomization
  • Fertile participants must agree to use a highly effective method of contraception
  • Has at least 1 characteristic or underlying medical condition associated with an increased risk of developing severe illness from COVID-19

Exclusion Criteria:

  • History of or need for hospitalization for the medical treatment of COVID-19
  • Prior to current disease episode, any confirmed SARS-CoV-2 infection
  • Known medical history of active liver disease
  • Receiving dialysis or have known moderate to severe renal impairment
  • Known human immunodeficiency virus (HIV) infection with a viral load greater than 400 copies/mL or taking prohibited medications for HIV treatment
  • Suspected or confirmed concurrent active systemic infection other than COVID-19
  • History of hypersensitivity or other contraindication to any of the components of the study intervention
  • Current or expected use of any medications or substances that are highly dependent on CYP3A4 for clearance or are strong inducers of CYP3A4
  • Has received or is expected to receive convalescent COVID-19 plasma
  • Has received or is expected to receive any dose of a SARS-CoV-2 vaccine before the Day 34 visit
  • Participating in another interventional clinical study with an investigational compound or device, including those for COVID-19 through the long-term follow-up visit
  • Known prior participation in this trial or other trial involving PF-07321332
  • Oxygen saturation of <92% on room air, or on their standard home oxygen supplementation for those who regularly receive chronic supplementary oxygen for an underlying lung condition
  • Females who are pregnant or breastfeeding
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com
Listed Location Countries  ICMJE Argentina,   Brazil,   Bulgaria,   Colombia,   Czechia,   Hungary,   India,   Japan,   Korea, Republic of,   Malaysia,   Mexico,   Poland,   Puerto Rico,   Russian Federation,   South Africa,   Spain,   Taiwan,   Thailand,   Turkey,   Ukraine,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04960202
Other Study ID Numbers  ICMJE C4671005
2021-002895-38 ( EudraCT Number )
EPIC-HR ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date November 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP