Clinical trial NCT05890612: 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
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: COVID-19
Keywords: severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
PAXLOVID
post marketing surveillance (PMS)
Korea
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2023-06-06
Enrollment: 3000
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who received, are currently receiving, or are going to receive PAXLOVID according to locally approved label.

Brief summary: 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.


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.

Primary outcomes:
measure: Proportion of patients with an adverse event (AE)
timeFrame: Baseline through Day 33
measure: Proportion of patients with an adverse drug reaction (ADR)
timeFrame: Baseline through Day 33
measure: Proportion of patients with a serious AE (SAE)
timeFrame: Baseline through Day 33
measure: Proportion of patients with a serious ADR (SADR)
timeFrame: Baseline through Day 33
measure: Proportion of patients with an unexpected AE (UAE)
timeFrame: Baseline through Day 33
measure: Proportion of patients with an unexpected ADR (UADR)
timeFrame: Baseline through Day 33
measure: Proportion of patients with a serious unexpected AE (SUAE)
timeFrame: Baseline through Day 33
measure: Proportion of patients with a serious unexpected ADR (SUADR)
timeFrame: Baseline through Day 33
measure: Proportion of COVID-19-related hospitalization from any cause
timeFrame: Baseline through Day 33
measure: Proportion of COVID-19-related death from any cause
timeFrame: Baseline through Day 33
measure: Proportion of subjective assessment of COVID-19-related symptomatic change
timeFrame: Day 5, Day 14, Day 33
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Pfizer Korea
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: