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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
Results First Posted : August 14, 2023
Last Update Posted : August 14, 2023
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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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.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: PF-07321332 Drug: Ritonavir Drug: Placebo Phase 2 Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1440 participants
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
Official Title: 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
Actual Study Start Date : August 25, 2021
Actual Primary Completion Date : July 25, 2022
Actual Study Completion Date : July 25, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Ritonavir

Arms and Interventions
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Arm Intervention/treatment
Experimental: PF-07321332/ritonavir
Orally administered PF-07321332+ritonavir
 Drug: PF-07321332
PF-07321332 (tablet)

Drug: Ritonavir
Ritonavir (capsule)
Placebo Comparator: Placebo
Orally administered Placebo
 Drug: Placebo
Placebo (tablet)

Drug: Placebo
Placebo (capsule)


Outcome Measures
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Primary Outcome Measures :
  1. Time to Sustained Alleviation of Overall COVID-19 Signs and Symptoms Through Day 28 [ Time Frame: From Day 1 to Day 28 ]
    Sustained alleviation of targeted COVID-19 signs/symptoms was defined as the event occurring on the first 4 consecutive days when all symptoms scored as moderate or severe at the time of enrollment were scored as mild or absent and those scored mild or absent at the time of enrollment were scored as absent. Missing severity at baseline was considered as mild. Time to sustained alleviation of all targeted COVID-19 signs and symptoms through Day 28, was calculated as time (days) from start of study intervention or placebo (Day 1) until sustained alleviation of all targeted COVID-19 associated signs and symptoms. In this outcome measure time to sustained alleviation is reported consolidated for overall COVID-19 signs and symptoms.


Secondary Outcome Measures :
  1. Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious AEs and AEs Leading to Study and Study Drug Discontinuation [ Time Frame: From start of study intervention (Day 1) up to Day 34 ]
    An AE was defined as any untoward medical occurrence in a participant or clinical study participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening ; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity ; congenital anomaly/birth defect; or that was considered as an important medical event. TEAEs were defined as events that started on or after the study medication start date and time. AEs included both serious and all non-serious adverse events. AEs that led to study discontinuation and AEs that led to discontinuation of study intervention and then continued study were also reported in this outcome measure.

  2. Percentage of Participants With COVID-19 Related Hospitalization or Death From Any Cause Through Day 28 [ Time Frame: From Day 1 to Day 28 ]
    Percentage of participants with COVID-19 related hospitalization or death from any cause during the first 28 days of the study was estimated using the Kaplan-Meier (KM) method.

  3. Percentage of Participants With Death Through Week 24 [ Time Frame: From Day 1 to Week 24 ]
    Percentage of participants with death (all-cause) event were reported in this outcome measure.

  4. Number of COVID-19 Related Medical Visits Per Day Through Day 28 [ Time Frame: From Day 1 to Day 28 ]
    Number of COVID-19 related medical visits per day were reported in this outcome measure.

  5. Duration of Hospitalization and Intensive Care Unit (ICU) Stay Through Day 28 [ Time Frame: From Day 1 to Day 28 ]
  6. Percentage of Participants With Severe Signs and Symptoms of COVID-19 Through Day 28 [ Time Frame: From Day 1 to Day 28 ]
    Participants recorded a daily severity rating of their symptom severity over the past 24 hours based on a 4-point scale in which 0 was reported if no symptoms were present; 1 if mild; 2 if moderate; and 3 if severe. A participant with severe score for any targeted symptoms post-baseline was counted as severe. Vomiting and diarrhea each was rated on a 4-point frequency scale where 0 was reported for no occurrence, 1 for 1 to 2 times, 2 for 3 to 4 times, and 3 for 5 or greater. Sense of smell and sense of taste each be rated on a 3-point Likert scale where 0 was reported if the sense of smell/taste was the same as usual, 1 if the sense of smell/taste was less than usual, and 2 for no sense of smell/taste.

  7. Time to Sustained Resolution of Overall COVID-19 Signs and Symptoms Through Day 28 [ Time Frame: From Day 1 to Day 28 ]
    Sustained resolution was defined as when targeted symptoms are scored as absent for 4 consecutive days. The first day of the 4 consecutive-day period was considered the first event date.

  8. Time to Sustained Alleviation of Each COVID-19 Signs and Symptoms Through Day 28 [ Time Frame: From Day 1 to Day 28 ]
    Sustained alleviation of targeted COVID-19 signs/symptoms was defined as the event occurring on the first 4 consecutive days when all symptoms scored as moderate or severe at the time of enrollment were scored as mild or absent and those scored mild or absent at the time of enrollment were scored as absent. Missing severity at baseline was treated as mild. Time to sustained alleviation of all targeted COVID-19 signs and symptoms through Day 28, was calculated as time (days) from start of study intervention or placebo (Day 1) until sustained alleviation of all targeted COVID-19 associated signs and symptoms. In this outcome measure time to sustained alleviation is reported for each COVID-19 signs and symptoms.

  9. Time to Sustained Resolution of Each COVID-19 Signs and Symptoms Through Day 28 [ Time Frame: From Day 1 to Day 28 ]
    Sustained resolution was defined as when targeted symptoms are scored as absent for 4 consecutive days. The first day of the 4 consecutive-day period was considered the first event date. In this outcome measure time to sustained resolution is reported consolidated for each COVID-19 signs and symptoms.

  10. Percentage of Participants With Progression to Worsening Status of COVID-19 Signs and Symptoms [ Time Frame: From Day 1 to Day 28 ]
    Participants recorded a daily severity rating of their symptom severity over the past 24 hours based on a 4-point scale in which 0 was reported if no symptoms were present; 1 if mild; 2 if moderate; and 3 if severe. Vomiting and diarrhea was rated on a 4-point frequency scale where 0 is reported for no occurrence, 1 (mild) for 1 to 2 times, 2 (moderate) for 3 to 4 times, and 3 (severe) for 5 or greater. Progression to a worsening status for any targeted symptom was based up on increasing severity (i.e. the first time any targeted symptoms worsened after treatment relative to baseline).

  11. Percentage of Participants With Resting Peripheral Oxygen Saturation Greater Than or Equal to (>=) 95% at Day 1 and Day 5 [ Time Frame: Day 1 and Day 5 ]
    Percentage of participants with a resting peripheral oxygen saturation >=95% were reported in this outcome measure.

  12. Plasma Concentration Versus Time Summary of PF-07321332 [ Time Frame: Day 1: 1 hour post dose; Day 5: 0 minutes pre-dose ]
  13. Change From Baseline in Logarithm to Base10 (Log10) Transformed Viral Load at Days 3, 5, 10 and 14 [ Time Frame: Baseline, Days 3, 5, 10 and 14 ]
    Nasal samples were collected to estimate the viral load in participants in terms of logarithm to base 10 (log10) copies per milliliter.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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): NCT05011513


Locations
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Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
  Study Documents (Full-Text)

Documents provided by Pfizer:
Study Protocol  [PDF] June 9, 2022
Statistical Analysis Plan  [PDF] July 14, 2022

More Information
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Additional Information:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT05011513    
Other Study ID Numbers: C4671002
2021-002857-28 ( EudraCT Number )
EPIC-SR ( Other Identifier: Alias Study Number )
First Posted: August 18, 2021    Key Record Dates
Results First Posted: August 14, 2023
Last Update Posted: August 14, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
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

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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 Pfizer:
SARS-CoV-2 Infection
Additional relevant MeSH terms:
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COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Ritonavir
 Nirmatrelvir
HIV Protease Inhibitors
Viral Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors