A Study on Paxlovid Once in the Market, to Observe Its Safety and Effectiveness in Patients Who Have a High Chance of Getting Severe COVID-19

Pfizer

Status: Enrolling

Conditions: COVID-19

Study type: Observational

Funder types: Industry

Identifiers

NCT05890612

NCT05890612 (Registry Identifier)

C4671020

Details and patient eligibility

About

The purpose of this study is to look at the safety and effectiveness of PAXLOVID in the real world and not in clinical studies. The study observes patients who have a high chance of getting severe COVID-19 in Korea.

This study is seeking participants who are:

• Patients with mild-to-moderate COVID-19 symptoms and at high chance of getting severe COVID-19, including hospitalization or death.
• Patients who received, are currently receiving, or are going to receive PAXLOVID according to locally approved label.
• Patients who have signed informed consent documents after understanding all the important parts of the study.

All participants are treated according to routine medical practice and there are no scheduled visits required by this study. All participants will be studied for a follow-up period of 28 days from the last PAXLOVID treatment to understand the safety and the effectiveness of treatment.

Enrollment: 3,000 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who received, are currently receiving, or are going to receive PAXLOVID according to locally approved label.
• Patients (or a legally acceptable representative) who are willing to provide written informed consent/assent prior to study enrollment.

Exclusion criteria

• Patients with contraindication according to locally approved label of PAXLOVID.
• Patients who are going to receive any investigational medicine during the observation period.

Trial design

3,000 participants in 1 patient group

Participants receiving PAXLOVID

Description:

Participants receiving PAXLOVID according to locally approved label.