Post Marketing Surveillance to Observe Safety and Effectiveness of PAXLOVID in Patients With Positive Results of Viral Testing, and Who Are at High Risk for Progression to Severe COVID-19

What this Trial Is About

Researchers are evaluating the safety and effectiveness of PAXLOVID in real-world patients in Korea who have a high risk of developing severe COVID-19. This observational study focuses on patients with mild-to-moderate COVID-19 symptoms who are at risk of hospitalization or death. The study is sponsored by Pfizer and aims to gather data outside of controlled clinical trials to better understand how PAXLOVID performs in everyday medical settings. Participants in this study are patients who have received, are currently receiving, or will receive PAXLOVID according to the locally approved label. The treatment follows routine medical practice without any extra scheduled visits required by the study. All participants receive PAXLOVID as prescribed and are observed in their normal care environments. During the study, participants are followed for 28 days after their last PAXLOVID treatment to monitor safety and effectiveness. Researchers will assess various outcomes, such as the occurrence of adverse events, adverse drug reactions, serious and unexpected adverse events, COVID-19-related hospitalizations, deaths, and symptom changes over this period. The study collects data through routine care without additional procedures or visits.

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