NCT05263908

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

General Investigation for PAXLOVID PAC

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 3,346 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• SARS-CoV-2 Infection

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-03-31
• Primary completion: 2023-07-10
• Completion: 2023-07-10
• First posted: 2022-03-03
• Last updated: 2025-09-03
• Results posted: 2025-09-03

Locations

1 site across 1 country: Japan