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Evaluation of Protease Inhibition for COVID-19 in Standard-Risk Patients (EPIC-SR).

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05011513
Recruitment Status : Terminated (Enrollment ceased due to a very low rate of hospitalization or death observed in the standard-risk patient population)
First Posted : August 18, 2021
Last Update Posted : December 12, 2022
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE July 30, 2021
First Posted Date  ICMJE August 18, 2021
Last Update Posted Date December 12, 2022
Actual Study Start Date  ICMJE August 25, 2021
Actual Primary Completion Date July 25, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 16, 2021)		 Time to Sustained Alleviation of All Targeted COVID-19 Signs/Symptoms [ Time Frame: Baseline through Day 28 ]
Analysis set includes COVID-19 symptom onset 1-3 days before treatment.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 16, 2021)
  • Percentage of Participants Who Experience Adverse Events (AEs) [ Time Frame: Baseline through Day 34 ]
  • Percentage of Participants Who Experience an AE(s) or Serious Adverse Events (SAEs) that Leads to Study Discontinuation [ Time Frame: Baseline through Day 34 ]
  • Proportion of Participants With Severe Signs/Symptoms Attributed to COVID-19 [ Time Frame: Baseline through Day 28 ]
  • Time to Sustained Resolution of All Targeted COVID-19 Signs/Symptoms [ Time Frame: Baseline through Day 28 ]
  • Duration of Each Targeted COVID-19 Sign/Symptom [ Time Frame: Baseline through Day 28 ]
  • Proportion of Participants Progressing to a Worsening Status In 1 or More COVID-19 Signs/Symptoms [ Time Frame: Baseline through Day 28 ]
  • Proportion of Participants With a Resting Peripheral Oxygen Saturation ≥95% [ Time Frame: Days 1, 5 ]
  • Number of COVID-19 Related Medical Visits [ Time Frame: Baseline through Day 28 ]
  • Number of Days in Hospital and Intensive Care Unit (ICU) Stay in Participants With COVID-19 Related Hospitalization [ Time Frame: Baseline through Day 28 ]
  • Proportion of Participants With COVID-19 Related Hospitalization or Death From Any Cause [ Time Frame: Baseline through Day 28 ]
  • Proportion of Participants With Death (all cause) [ Time Frame: Baseline through Week 24 ]
  • Minimal Concentration (Ctrough) of PF-07321332 [ Time Frame: Baseline through Day 5 ]
  • Viral Titers Measured Via Reverse Transcription Polymerase Chain Reaction (RT-PCR) in Nasal Swabs [ Time Frame: Baseline through Day 14 ]
  • Time to Sustained Alleviation of All Targeted COVID-19 Signs/Symptoms [ Time Frame: Baseline through Day 28 ]
    Analysis set includes COVID-19 symptom onset 1-5 days before treatment.
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 Evaluation of Protease Inhibition for COVID-19 in Standard-Risk Patients (EPIC-SR).
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 LOW RISK OF PROGRESSING TO SEVERE ILLNESS
Brief Summary The primary hypothesis to be tested is whether or not there is a difference in time to sustained alleviation of all targeted COVID-19 signs and symptoms through Day 28 between PF-07321332/ritonavir and placebo.
Detailed Description Throughout the study period, provision will be made to allow study visits to be conducted at a participant's home or at another non-clinic location, if available. The total study duration is up to 24 weeks.
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)
Masking Description:
Double-blind
Primary Purpose: Treatment
Condition  ICMJE COVID-19
Intervention  ICMJE
  • Drug: PF-07321332
    PF-07321332 (tablet)
  • Drug: Ritonavir
    Ritonavir (capsule)
  • Drug: Placebo
    Placebo (tablet)
  • Drug: Placebo
    Placebo (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
    Interventions:
    • Drug: Placebo
    • 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 Terminated
Actual Enrollment  ICMJE
 (submitted: November 8, 2022)		 1411
Original Estimated Enrollment  ICMJE
 (submitted: August 16, 2021)		 1140
Actual Study Completion Date  ICMJE July 25, 2022
Actual Primary Completion Date July 25, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Confirmed SARS-CoV-2 infection 5 days prior to randomization
  • Initial onset of COVID-19 signs/symptoms within 5 days of randomization
  • Fertile participants must agree to use a highly effective method of contraception

Exclusion Criteria:

  • Has at least one underlying medical condition associated with an increased risk of developing severe illness from COVID-19
  • History of or need for hospitalization for the medical treatment of COVID-19
  • Prior diagnosis of SARS-CoV-2 infection (reinfection)
  • Known medical history of liver disease
  • Receiving dialysis or have known renal impairment
  • Known Human Immunodeficiency Virus (HIV) infection with viral load > 400 copies/ml or taking prohibited medications for HIV treatment
  • Suspected or confirmed concurrent active systemic infection other than COVID-19
  • Current or expected use of any medications or substances that are highly dependent on Cytochrome P450 3A4 (CYP3A4) for clearance or are strong inducers of CYP3A4
  • Has received or is expected to receive monoclonal antibody treatment or convalescent COVID-19 plasma
  • Has received any SARS-CoV-2 vaccine within 12 months of screening
  • Participating in another interventional clinical study with an investigational compound or device, including those for COVID-19
  • Known prior participation in this trial or other trial involving PF-07321332
  • Oxygen saturation of < 92% on room air
  • 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 information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Brazil,   Bulgaria,   Colombia,   Czechia,   Hungary,   Japan,   Korea, Republic of,   Malaysia,   Mexico,   Poland,   Puerto Rico,   Romania,   Slovakia,   South Africa,   Spain,   Thailand,   Turkey,   Ukraine,   United States
Removed Location Countries Russian Federation,   Taiwan
 
Administrative Information
NCT Number  ICMJE NCT05011513
Other Study ID Numbers  ICMJE C4671002
2021-002857-28 ( EudraCT Number )
EPIC-SR ( 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
Current Responsible Party Pfizer
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Pfizer
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date December 2022

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