A Study to Learn About PAXLOVID (a Commercial Medicine) In People With COVID-19

Completed

• Conditions: SARS-CoV-2 Infection
• Interventions: Drug: nirmatrelvir / ritonavir

• Registration Number: NCT05263908
• Lead Sponsor: Pfizer

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-02-25
• Study First Submitted QC: 2022-02-25
• Study First Posted: 2022-03-03
• Study Start: 2022-03-31
• Primary Completion: 2023-07-10
• Study Completion: 2023-07-10
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-28
• Last Update Posted: 2024-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3346

Inclusion Criteria

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

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Exclusion Criteria

• There are no exclusion criteria for this study.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PAXLOVID PACK	nirmatrelvir / ritonavir	Subjects administered PAXLOVID PACK

Primary Outcome Measures

Name	Time	Method
Incidence of adverse drug reactions	34 days

Secondary Outcome Measures

Name	Time	Method
Ratio of subjects with worsening severity	34 days

Trial Locations

Locations (1)

Pfizer Local County; 🇯🇵 Tokyo, Japan