What is this study trying to find out about COVID-19?

This study is observing how safe and effective PAXLOVID is in patients at high risk of severe COVID-19 in a real-world setting. Researchers want to learn about outcomes like hospitalizations, deaths, and symptom changes after treatment. The study is sponsored by Pfizer to better understand patient experiences outside clinical trials.

Who may be eligible for this COVID-19 clinical trial?

Adults aged 19 years or older who have received, are receiving, or will receive PAXLOVID are eligible. Participants must be willing to provide informed consent and not have contraindications to PAXLOVID or be receiving other investigational medicines during the study. Please review eligibility criteria for more details.

Is there any cost to participate in this COVID-19 clinical trial?

Study-related care, including PAXLOVID and all trial visits, is provided at no cost. However, personal travel or other expenses may vary and are not guaranteed to be covered. Participants should consider these potential costs when joining.

Actively Recruiting

Age: 19Years +

All Genders

ID05890612

Post-Marketing Study to Monitor Safety and Effectiveness of PAXLOVID in Adults at High Risk of Severe COVID-19

Led by Pfizer · Updated on 2026-08-12

3000

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

This observational study evaluates the safety and effectiveness of PAXLOVID in patients at high risk of severe COVID-19 in Korea. It focuses on individuals with mild-to-moderate COVID-19 symptoms who are at increased risk of hospitalization or death. The study aims to observe real-world outcomes rather than results from controlled clinical trials. Participants in this study are those who have received, are currently receiving, or will receive PAXLOVID according to the locally approved label. All treatments follow routine medical practice without any additional interventions or scheduled study visits. The study monitors participants for 28 days after their last PAXLOVID dose to gather safety and effectiveness data. Throughout the study, participants health is observed with no required extra visits. Researchers collect information on adverse events, drug reactions, hospitalizations related to COVID-19, deaths, and changes in COVID-19 symptoms during the follow-up period. The total follow-up lasts up to 33 days from baseline to assess these outcomes in a real-world setting.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 19Years +

All Genders

Eligibility Criteria

You may qualify if you...

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.

You will not qualify if you...

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

Research Team

Pfizer CT.gov Call Center

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