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

Pfizer3,000 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

3,000

Conditions

COVID-19

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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.

Locations (1)

Outcomes

Primary Outcomes

Proportion of patients with an adverse event (AE)

The number of AEs experienced, the incidence rate, and the number of occurrences among all subjects who received the drug and received at least one safety evaluation will be measured.