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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-29

Study Completion Date

2029-07-13

Brief Summary

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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.

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Detailed Description

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Conditions

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COVID-19

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

OTHER

Study Groups

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Participants receiving PAXLOVID

Participants receiving PAXLOVID according to locally approved label.

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No