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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: COVID-19. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
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.
Primary outcome measures
- Proportion of patients with an adverse event (AE) [Time frame: Baseline through Day 33]
- Proportion of patients with an adverse drug reaction (ADR) [Time frame: Baseline through Day 33]
- Proportion of patients with a serious AE (SAE) [Time frame: Baseline through Day 33]
- Proportion of patients with a serious ADR (SADR) [Time frame: Baseline through Day 33]
- Proportion of patients with an unexpected AE (UAE) [Time frame: Baseline through Day 33]
- Proportion of patients with an unexpected ADR (UADR) [Time frame: Baseline through Day 33]
- Proportion of patients with a serious unexpected AE (SUAE) [Time frame: Baseline through Day 33]
- Proportion of patients with a serious unexpected ADR (SUADR) [Time frame: Baseline through Day 33]
- Proportion of COVID-19-related hospitalization from any cause [Time frame: Baseline through Day 33]
- Proportion of COVID-19-related death from any cause [Time frame: Baseline through Day 33]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
South Korea · 1 center
- Pfizer Korea — Seoul
Identifiers
NCT: NCT05890612 · C4671020 · NCT05890612