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A Study to Learn About PAXLOVID (a Commercial Medicine) In People With 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: NCT05263908
Recruitment Status : Recruiting
First Posted : March 3, 2022
Last Update Posted : March 13, 2023
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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Brief Summary:

The purpose of this post marketing observational study is to learn about the safety and effects of the commercial medicine (called PAXLOVID) for the treatment of COVID-19. This study is intended to be registered with the participants who:

  • Have taken PAXLOVID PACK and have no history of using this medicine.
  • Are 12 years and older

All participants will receive PAXLOVID, a standard treatment for COVID-19. Participants will take PAXLOVID 2 times a day by mouth or as prescribed.

We will examine the experiences of people taking PAXLOVID. This will help us determine if PAXLOVID is safe and effective.

Participants will be followed up for 28 days after taking PAXLOVID. During this time, participants will be closely watched for the safety and effects of PAXLOVID.


Condition or disease Intervention/treatment
SARS-CoV-2 Infection Drug: nirmatrelvir / ritonavir

Detailed Description:
This is a multicenter cohort study to be conducted in individuals with SARS-CoV-2 infection who are treated with this product, and the investigator will enter the information required in this study in the case report forms (CRFs) based on the information obtained through medical records.
Study Design
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Study Type : Observational
Estimated Enrollment : 3300 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: General Investigation for PAXLOVID PAC
Actual Study Start Date : March 31, 2022
Estimated Primary Completion Date : July 10, 2023
Estimated Study Completion Date : July 10, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
PAXLOVID PACK
Subjects administered PAXLOVID PACK
 Drug: nirmatrelvir / ritonavir
The usual dosage in adults and pediatric patients (≥12 years of age weighing ≥40 kg) is 300 mg of Nirmatrelvir and 100 mg of ritonavir all taken together orally twice daily for 5 days.
Other Name: PAXLOVID PACK


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of adverse drug reactions [ Time Frame: 34 days ]

Secondary Outcome Measures :
  1. Ratio of subjects with worsening severity [ Time Frame: 34 days ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The subjects who have been treated with PAXLOVID PACK for the first time.
Criteria

Inclusion Criteria:

  • Subjects who are administered PAXLOVID PACK and have no history of using this drug.

Exclusion Criteria:

  • There are no exclusion criteria for this study.
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): NCT05263908


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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Japan
Pfizer Local County Recruiting
Tokyo, Japan, 1518589
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT05263908    
Other Study ID Numbers: C4671018
First Posted: March 3, 2022    Key Record Dates
Last Update Posted: March 13, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.
Keywords provided by Pfizer:
severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
coronavirus disease 2019 (COVID-19)
Paxlovid
Nirmatrelvir
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
Nirmatrelvir and ritonavir drug combination
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