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A Post-Exposure Prophylaxis Study of PF-07321332/Ritonavir in Adult Household Contacts of an Individual With Symptomatic COVID-19

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05047601
Recruitment Status : Recruiting
First Posted : September 17, 2021
Last Update Posted : December 1, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of PF-07321332/ritonavir as postexposure prophylaxis for adult household contacts of a patient with COVID-19

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

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Study Type : Interventional
Estimated Enrollment : 2634 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Eligible participants who are asymptomatic household contacts of an individual with symptomatic COVID-19 will be randomized (1:1:1) to receive orally every 12 hours:

PF-07321332/ritonavir for 5 days followed by placebo for 5 days or PF-07321332/ritonavir for 10 days or Placebo for 10 days

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double Blind Double Dummy
Primary Purpose: Prevention
Official Title: A PHASE 2/3, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO CONTROLLED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF 2 REGIMENS OF ORALLY ADMINISTERED PF 07321332/RITONAVIR IN PREVENTING SYMPTOMATIC SARS-COV-2 INFECTION IN ADULT HOUSEHOLD CONTACTS OF AN INDIVIDUAL WITH SYMPTOMATIC COVID-19
Actual Study Start Date : September 9, 2021
Estimated Primary Completion Date : March 2, 2022
Estimated Study Completion Date : March 2, 2022


Arm Intervention/treatment
Experimental: PF-07321332/ritonavir (5 days)
Participants will receive PF-07321332/ritonavir every 12 hours from Day 1 through Day 5 followed by Placebo every 12 hours from Day 6 through Day 10
Drug: PF-07321332
PF-07321332

Drug: Placebo for PF-07321332
Placebo

Drug: Placebo for Ritonavir
Placebo

Drug: Ritonavir
Ritonavir

Experimental: PF-07321332/ritonavir (10-Day)
Participants will receive PF-07321332/ritonavir every 12 hours from Day 1 through Day 10.
Drug: PF-07321332
PF-07321332

Drug: Ritonavir
Ritonavir

Placebo Comparator: Placebo
Participants will receive placebo every 12 hours from Day 1 through Day 10.
Drug: Placebo for PF-07321332
Placebo

Drug: Placebo for Ritonavir
Placebo




Primary Outcome Measures :
  1. Proportion of participants who have a negative reverse transcription polymerase chain reaction (RT-PCR) result at baseline who develop a symptomatic, RT-PCR confirmed SARS-CoV-2 infection. [ Time Frame: Day 1 through Day 14 ]

Secondary Outcome Measures :
  1. Percentage of participants who experience adverse events [ Time Frame: Day 1 through Day 38 ]
  2. Efficacy in preventing symptomatic COVID-19 in participants who have a negative RT-PCR result at baseline and are at increased risk of severe COVID-19 illness [ Time Frame: Day 1 through Day 14 ]
    Proportion of participants with symptomatic, RT-PCR confirmed SARS-CoV-2 infection through Day 14

  3. Efficacy in preventing symptomatic COVID-19 in participants who have a negative RT-PCR result at baseline and are at increased risk of severe COVID-19 illness [ Time Frame: Day 1 through Day 28 ]
    Proportion of participants with COVID-19 related hospitalization or death from any cause

  4. Prevention of SARS CoV-2 infection in participants by RT-PCR status at enrolment [ Time Frame: Day 1 through Day 14 ]
    Proportion of participants with symptomatic or asymptomatic, RT-PCR confirmed SARS-CoV-2 infection.

  5. Prevention of SARS CoV-2 infection in participants who have a negative RT-PCR result at baseline [ Time Frame: Day 1 through Day 14 ]
    Time to SARS-CoV-2 infection.

  6. Compare the duration of COVID-19 related signs and symptoms in participants who have a negative RT-PCR result at baseline [ Time Frame: Day 1 through Day 28 ]
  7. Compare the severity of COVID-19 related signs and symptoms in participants who have a negative RT-PCR result at baseline [ Time Frame: Day 1 through Day 28 ]
  8. Minimal Concentration (Ctrough) of PF-07321332 [ Time Frame: Day 1 post dose, Day 5 pre dose ]
  9. All cause mortality in participants who have a negative RT-PCR result at baseline [ Time Frame: Day 1 through Day 38 ]
  10. Viral titers measured via RT-PCR in nasal swabs in participants who have a negative RT-PCR result at baseline [ Time Frame: Day 1 through Day 14 ]
  11. Number of days of hospital and intensive care unit stay in participants with COVID-19 related hospitalization who have a negative RT-PCR result at baseline [ Time Frame: Day 1 through Day 28 ]
  12. Number of COVID-19 related medical visits in participants who have a negative RT-PCR result at baseline [ Time Frame: Day 1 through Day 28 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

  • Participants who have a negative screening SARS-CoV-2 rapid antigen test result and who are asymptomatic household contacts with exposure within 96 hours to an individual who is symptomatic and recently tested positive for SARS CoV-2.
  • Fertile participants must agree to use a highly effective method of contraception

Exclusion Criteria:

  • History of SARS-CoV-2 infection
  • Experiencing measured fever (documented temperature >38˚C or 100.4˚F) or other signs or symptoms consistent with COVID-19
  • Known medical history of active liver disease
  • Chronic Kidney Disease or have known moderate to severe renal impairment.
  • Known Human Immunodeficiency Virus (HIV) infection with viral load > 400 copies/ml within the last 6 months or taking prohibited medications for HIV treatment
  • Suspected or confirmed concurrent active systemic infection
  • Active cancer, other than localized skin cancer
  • 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 approved, authorized, or investigational anti-SARS-CoV-2 mAb, convalescent plasma, other drugs for treatment of COVID-19, or other anti-SARS-CoV-2 biologic products
  • Has received or is expected to receive a SARS-CoV-2 vaccine or other approved, authorized, or investigational postexposure prophylaxis treatments during the study period
  • Participating in another interventional clinical study with an investigational compound or device, including those for COVID-19
  • Known or prior participation in this trial or another trial involving PF-07321332.
  • Females who are pregnant or breastfeeding.

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): NCT05047601


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
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Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT05047601    
Other Study ID Numbers: C4671006
2021-002894-24 ( EudraCT Number )
EPIC-PEP ( Other Identifier: Alias Study Number )
First Posted: September 17, 2021    Key Record Dates
Last Update Posted: December 1, 2021
Last Verified: November 2021
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:
Severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2)
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
Ritonavir
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