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

ConditionCOVID-19
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19+
SponsorPfizer

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Patients with contraindication according to locally approved label of PAXLOVID.

Patients who are going to receive any investigational medicine during the observation period.

Trial population

Patients who received, are currently receiving, or are going to receive PAXLOVID according to locally approved label.

Trial design

Design model

Case-only

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

3,000 Participants
are grouped into 1 trial group
Group A: Participants receiving PAXLOVID

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline through Day 33
2

Proportion of patients with an adverse drug reaction (ADR)

The number of ADRs 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.

Time frame
Baseline through Day 33
3

Proportion of patients with a serious AE (SAE)

The number of SAEs 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.

Time frame
Baseline through Day 33
4

Proportion of patients with a serious ADR (SADR)

The number of SADRs 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.

Time frame
Baseline through Day 33

Secondary outcomes

Other outcomes

Sponsors and contacts

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