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

Study Overview
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Brief Summary
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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.

Official Title
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Post Marketing Surveillance to Observe Safety and Effectiveness of PAXLOVID in Patients, and Who Are at High Risk for Progression to Severe COVID-19

Conditions
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COVID-19

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants receiving PAXLOVID<br>Participants receiving PAXLOVID according to locally approved label. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline through Day 33 | 
| 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. | Baseline through Day 33 | 
| 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. | Baseline through Day 33 | 
| 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. | Baseline through Day 33 | 
| Proportion of patients with an unexpected AE (UAE) | The number of UAEs 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. | Baseline through Day 33 | 
| Proportion of patients with an unexpected ADR (UADR) | The number of UADRs 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. | Baseline through Day 33 | 
| Proportion of patients with a serious unexpected AE (SUAE) | The number of SUAEs 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. | Baseline through Day 33 | 
| Proportion of patients with a serious unexpected ADR (SUADR) | The number of SUADRs 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. | Baseline through Day 33 | 
| Proportion of COVID-19-related hospitalization from any cause | The number and rate of COVID-19-related hospitalizations among all subjects who received the drug and received at least one safety evaluation will be measured. | Baseline through Day 33 | 
| Proportion of COVID-19-related death from any cause | The number and rate of COVID-19-related deaths among all subjects who received the drug and received at least one safety evaluation will be measured. | Baseline through Day 33 | 
| Proportion of subjective assessment of COVID-19-related symptomatic change | The rate of subjective assessment change (improve/no change/worsened) compared to the baseline for COVID-19-related overall symptoms of all subjects who received the drug and received at least one safety evaluation will be measured. | Day 5, Day 14, Day 33 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), PAXLOVID, post marketing surveillance (PMS), Korea