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

• ClinicalTrials.gov Identifier: NCT04960202
• Recruitment Status: Completed
• First Posted: July 13, 2021
• Results First Posted: February 9, 2023
• Last Update Posted: February 9, 2023
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Tracking Information

• First Submitted Date: July 10, 2021
• First Posted Date: July 13, 2021
• Results First Submitted Date: November 22, 2022
• Results First Posted Date: February 9, 2023
• Last Update Posted Date: February 9, 2023
• Actual Study Start Date: July 16, 2021
• Actual Primary Completion Date: December 9, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 13, 2023)

Percentage of Participants With Covid-19 Related Hospitalization or Death From Any Cause Through Day 28- Modified Intent-To-Treat (mITT) Population [ 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. Using KM method, survival probability for each time interval was calculated as the number of participants surviving divided by the number of participants at risk. Participants who had the event, dropped out, or moved out were not counted as "at risk" i.e., participants who were lost were considered "censored" and were not counted in the denominator.

• Original Primary Outcome Measures (submitted: July 10, 2021): Proportion of participants with COVID-19 related hospitalization or death from any cause [ Time Frame: Day 1 through Day 28 ]

Current Secondary Outcome Measures (submitted: November 22, 2022)

• Number of Participants With Treatment Emergent Adverse Events (TEAEs) [ Time Frame: From start of study intervention (Day 1) up to end of safety follow-up (Day 34) ]
  An adverse event (AE) was any untoward medical occurrence in a participant, temporarily associated with the use of study intervention, whether or not considered related to the study intervention. Serious adverse event (SAE) was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/ incapacity; congenital anomaly/birth defect; a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic and other important medical events. AEs included both SAEs and all non-SAEs. An AE was considered as TEAE if the event started on or after start date of study intervention.
• Number of Participants With AEs Leading to Discontinuation and Serious Adverse Events (SAEs) [ Time Frame: From start of study intervention (Day 1) up to end of safety follow-up (Day 34) ]
  An AE was any untoward medical occurrence in a participant, temporarily associated with the use of study treatment, whether or not considered related to the study treatment. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/ incapacity; congenital anomaly/birth defect; a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic and other important medical events.
• Percentage of Participants With Covid-19 Related Hospitalization or Death From Any Cause Through Day 28- Modified Intent-To-Treat 1 (mITT1) Population [ 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 method.
• Time to Sustained Alleviation of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT Population [ Time Frame: From Day 1 (baseline) to Day 28 ]
  Sustained alleviation of all 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. The first day of the 4 consecutive-day period was considered date of first event. Time to sustained alleviation (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained alleviation (censored), time was calculated as censoring date (last date on which symptom alleviation was assessed) minus first dose date plus 1 or Day 25 whichever occurred first.
• Time to Sustained Alleviation of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT1 Population [ Time Frame: From Day 1 (baseline) to Day 28 ]
  Sustained alleviation of all 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. The first day of the 4 consecutive-day period was considered date of first event. Time to sustained alleviation (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained alleviation (censored), time was calculated as censoring date (last date on which symptom alleviation was assessed) minus first dose date plus 1 or Day 25 whichever occurred first.
• Time to Sustained Alleviation of All Targeted COVID-19 Signs and Symptoms Through Day 28- Modified Intent-to-Treat 2 (mITT2) Population [ Time Frame: From Day 1 (baseline) to Day 28 ]
  Sustained alleviation of all 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. The first day of the 4 consecutive-day period was considered date of first event. Time to sustained alleviation (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained alleviation (censored), time was calculated as censoring date (last date on which symptom alleviation was assessed) minus first dose date plus 1 or Day 25 whichever occurred first.
• Percentage of Participants With Severe Covid-19 Signs and Symptoms Through Day 28- mITT Population [ Time Frame: From Day 1 to Day 28 ]
  Participants were required to record the severity of their Covid-19 symptoms over the past 24 hours daily on a 4-point scale ranging from 0 to 3, higher scores indicated more severity. The scale was reported as 0= no symptoms, 1=mild, 2=moderate and 3=severe. A participant with severe score for any targeted symptoms post-baseline was counted as severe. Percentage of participants with severe Covid-19 signs and symptoms were reported.
• Percentage of Participants With Severe Covid-19 Signs and Symptoms Through Day 28- mITT1 Population [ Time Frame: From Day 1 to Day 28 ]
  Participants were required to record the severity of their Covid-19 symptoms over the past 24 hours daily on a 4-point scale ranging from 0 to 3, higher scores indicated more severity. The scale was reported as 0= no symptoms, 1=mild, 2=moderate and 3=severe. A participant with severe score for any targeted symptoms post-baseline was counted as severe. Percentage of participants with severe Covid-19 signs and symptoms were reported.
• Percentage of Participants With Severe Covid-19 Signs and Symptoms Through Day 28- mITT2 Population [ Time Frame: From Day 1 to Day 28 ]
  Participants were required to record the severity of their Covid-19 symptoms over the past 24 hours daily on a 4-point scale ranging from 0 to 3, higher scores indicated more severity. The scale was reported as 0= no symptoms, 1=mild, 2=moderate and 3=severe. A participant with severe score for any targeted symptoms post-baseline was counted as severe. Percentage of participants with severe Covid-19 signs and symptoms were reported.
• Time to Sustained Resolution of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT Population [ Time Frame: From Day 1 (baseline) to Day 28 ]
  Sustained resolution was defined as when all targeted symptoms were scored as absent for 4 consecutive days. Time to sustained resolution (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained resolution (censored), time was calculated as censoring date (last date on which symptom resolution was assessed) minus first dose date plus 1 or Day 25 whichever occurred first.
• Time to Sustained Resolution of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT1 Population [ Time Frame: From Day 1 (baseline) to Day 28 ]
  Sustained resolution was defined as when all targeted symptoms were scored as absent for 4 consecutive days. Time to sustained resolution (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained resolution (censored), time was calculated as censoring date (last date on which symptom resolution was assessed) minus first dose date plus 1 or Day 25 whichever occurred first.
• Time to Sustained Resolution of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT2 Population [ Time Frame: From Day 1 (baseline) to Day 28 ]
  Sustained resolution was defined as when all targeted symptoms were scored as absent for 4 consecutive days. Time to sustained resolution (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained resolution (censored), time was calculated as censoring date (last date on which symptom resolution was assessed) minus first dose date plus 1 or Day 25 whichever occurred first.
• Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT Population [ Time Frame: From Day 1 (baseline) to Day 28 ]
  Sustained alleviation of each targeted COVID-19 signs/symptoms was defined as the event occurring on the first 4 consecutive days when each symptom 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. The first day of the 4 consecutive-day period was considered date of first event. Time to sustained alleviation (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained alleviation (censored), time was calculated as censoring date (last date on which symptom alleviation was assessed) minus first dose date plus 1 or Day 25 whichever occurred first.
• Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population [ Time Frame: From Day 1 (baseline) to Day 28 ]
  Sustained alleviation of each targeted COVID-19 signs/symptoms was defined as the event occurring on the first 4 consecutive days when each symptom 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. The first day of the 4 consecutive-day period was considered date of first event. Time to sustained alleviation (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained alleviation (censored), time was calculated as censoring date (last date on which symptom alleviation was assessed) minus first dose date plus 1 or Day 25 whichever occurred first.
• Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population [ Time Frame: From Day 1 (baseline) to Day 28 ]
  Sustained alleviation of each targeted COVID-19 signs/symptoms was defined as the event occurring on the first 4 consecutive days when each symptom 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. The first day of the 4 consecutive-day period was considered date of first event. Time to sustained alleviation (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained alleviation (censored), time was calculated as censoring date (last date on which symptom alleviation was assessed) minus first dose date plus 1 or Day 25 whichever occurred first.
• Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT Population [ Time Frame: From Day 1 (baseline) to Day 28 ]
  Sustained resolution was defined as when each targeted symptom was scored as absent for 4 consecutive days. Time to sustained resolution (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained resolution (censored), time was calculated as censoring date (last date on which symptom resolution was assessed) minus first dose date plus 1 or Day 25 whichever occurred first.
• Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population [ Time Frame: From Day 1 (baseline) to Day 28 ]
  Sustained resolution was defined as when each targeted symptom was scored as absent for 4 consecutive days. Time to sustained resolution (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained resolution (censored), time was calculated as censoring date (last date on which symptom resolution was assessed) minus first dose date plus 1 or Day 25 whichever occurred first.
• Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population [ Time Frame: From Day 1 (baseline) to Day 28 ]
  Sustained resolution was defined as when each targeted symptom was scored as absent for 4 consecutive days. Time to sustained resolution (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained resolution (censored), time was calculated as censoring date (last date on which symptom resolution was assessed) minus first dose date plus 1 or Day 25 whichever occurred first.
• Number of Participants With Progression to a Worsening Status in 1 or More Self-reported COVID-19 Associated Symptoms Through Day 28-mITT Population [ Time Frame: From Day 1 (baseline) to Day 28 ]
  Participants were required to record the severity of their Covid-19 symptoms over the past 24 hours daily on a 4-point scale where 0 = no symptoms; 1= mild; 2= moderate; and 3= severe. Vomiting and diarrhea were each rated on a 4-point frequency scale where 0= 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).
• Number of Participants With Progression to a Worsening Status in 1 or More Self-reported COVID-19 Associated Symptoms Through Day 28-mITT1 Population [ Time Frame: From Day 1 (baseline) to Day 28 ]
  Participants were required to record the severity of their Covid-19 symptoms over the past 24 hours daily on a 4-point scale where 0 = no symptoms; 1= mild; 2= moderate; and 3= severe. Vomiting and diarrhea were each rated on a 4-point frequency scale where 0= 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).
• Number of Participants With Progression to a Worsening Status in 1 or More Self-reported COVID-19 Associated Symptoms Through Day 28-mITT2 Population [ Time Frame: From Day 1 (baseline) to Day 28 ]
  Participants were required to record the severity of their Covid-19 symptoms over the past 24 hours daily on a 4-point scale where 0 = no symptoms; 1= mild; 2= moderate; and 3= severe. Vomiting and diarrhea were each rated on a 4-point frequency scale where 0= 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).
• Percentage of Participants With a Resting Peripheral Oxygen Saturation >=95% at Days 1 and 5- mITT Population [ Time Frame: Day 1, 5 ]
  In this outcome measure, the percentage of participants with a resting peripheral oxygen saturation >=95% were reported.
• Percentage of Participants With a Resting Peripheral Oxygen Saturation >=95% at Days 1 and 5- mITT1 Population [ Time Frame: Day 1, 5 ]
  In this outcome measure, the percentage of participants with a resting peripheral oxygen saturation >=95% were reported.
• Percentage of Participants With a Resting Peripheral Oxygen Saturation >=95% at Days 1 and 5- mITT2 Population [ Time Frame: Day 1, 5 ]
  In this outcome measure, the percentage of participants with a resting peripheral oxygen saturation >=95% were reported.
• Percentage of Participants Who Died Through Week 24- mITT Population [ Time Frame: From Day 1 up to Week 24 ]
  In this outcome measure, percentage of participants with death due to any cause was presented.
• Percentage of Participants Who Died Through Week 24- mITT1 Population [ Time Frame: From Day 1 up to Week 24 ]
  In this outcome measure, percentage of participants with death due to any cause was presented.
• Percentage of Participants Who Died Through Week 24- mITT2 Population [ Time Frame: From Day 1 up to Week 24 ]
  In this outcome measure, percentage of participants with death due to any cause was presented.
• Plasma Concentration Versus Time Summary of PF-07321332 [ Time Frame: 1 Hour post-dose on Day 1 and pre-dose on Day 5 ]
• Change From Baseline in Logarithm to Base10 (Log10) Transformed Viral Load at Day 3, 5, 10 and 14- mITT Population [ Time Frame: Baseline, Day 3, 5, 10 and 14 ]
  The viral load was measured in nasal or nasopharyngeal samples using reverse transcription polymerase chain reaction (RT-PCR).
• Change From Baseline in Log10 Transformed Viral Load at Day 3, 5, 10 and 14- mITT1 Population [ Time Frame: Baseline, Day 3, 5, 10 and 14 ]
  The viral load was measured in nasal or nasopharyngeal samples using RT-PCR.
• Change From Baseline in Log10 Transformed Viral Load at Day 3, 5, 10 and 14- mITT2 Population [ Time Frame: Baseline, Day 3, 5, 10 and 14 ]
  The viral load was measured in nasal or nasopharyngeal samples using RT-PCR.
• Number of COVID-19 Related Medical Visits- mITT Population [ Time Frame: From Day 1 up to Day 34 ]
  Medical visits included emergency room, practitioner's office, home healthcare services, urgent care, telephone consultation, outpatient infusion center, other, COVID-19-related-hospitalization (intensive care unit [ICU] and non-ICU stays). In this outcome measure, COVID-19-related medical visits of participants were reported.
• Number of COVID-19 Related Medical Visits- mITT1 Population [ Time Frame: From Day 1 up to Day 34 ]
  Medical visits included emergency room, practitioner's office, home healthcare services, urgent care, telephone consultation, outpatient infusion center, other, COVID-19-related-hospitalization (ICU and non-ICU stays). In this outcome measure, COVID-19-related medical visits of participants were reported.
• Number of COVID-19 Related Medical Visits- mITT2 Population [ Time Frame: From Day 1 up to Day 34 ]
  Medical visits included emergency room, practitioner's office, home healthcare services, urgent care, telephone consultation, outpatient infusion center, other, COVID-19-related-hospitalization (ICU and non-ICU stays). In this outcome measure, COVID-19-related medical visits of participants were reported.
• Number of Days in Hospital and ICU for the Treatment of COVID-19- mITT Population [ Time Frame: From Day 1 up to Day 34 ]
• Number of Days in Hospital and ICU for the Treatment of COVID-19- mITT1 Population [ Time Frame: From Day 1 up to Day 34 ]
• Number of Days in Hospital and ICU for the Treatment of COVID-19- mITT2 Population [ Time Frame: From Day 1 up to Day 34 ]

Original Secondary Outcome Measures (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 ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: EPIC-HR: Study of Oral PF-07321332/Ritonavir Compared With Placebo in Nonhospitalized High Risk Adults With COVID-19
• 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 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: Interventional
• Study Phase: Phase 2; Phase 3

Study Design

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: COVID-19

Intervention

• Drug: PF-07321332
  PF-07321332 (tablet)
• Drug: Ritonavir
  Ritonavir (capsule)
• Drug: Placebo
  Placebo (tablet or capsule)

Study Arms

• 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 *: Hammond J, Leister-Tebbe H, Gardner A, Abreu P, Bao W, Wisemandle W, Baniecki M, Hendrick VM, Damle B, Simon-Campos A, Pypstra R, Rusnak JM; EPIC-HR Investigators. Oral Nirmatrelvir for High-Risk, Nonhospitalized Adults with Covid-19. N Engl J Med. 2022 Apr 14;386(15):1397-1408. doi: 10.1056/NEJMoa2118542. Epub 2022 Feb 16.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 22, 2022): 2246
• Original Estimated Enrollment (submitted: July 10, 2021): 2260
• Actual Study Completion Date: April 25, 2022
• Actual Primary Completion Date: December 9, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Argentina, Brazil, Bulgaria, Colombia, Czechia, Hungary, India, Japan, Korea, Republic of, Malaysia, Mexico, Poland, Puerto Rico, Russian Federation, South Africa, Spain, Thailand, Turkey, Ukraine, United States
• Removed Location Countries: Taiwan

Administrative Information

• NCT Number: NCT04960202
• Other Study ID Numbers: 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

• 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: Pfizer
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: January 2023