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 Details
Study Description
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 with positive results of viral testing, and who have a high chance of getting severe COVID-19 in Korea.
This study is seeking participants who are:
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Adults and children (12 years of age and older weighing at least 40 kgs) with positive results of viral testing.
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Patients with mild-to-moderate COVID-19 symptoms and at high chance of getting severe COVID-19, including hospitalization or death.
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Patients who received, are currently receiving, or are going to receive PAXLOVID according to locally approved label.
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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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Participants receiving PAXLOVID Participants receiving PAXLOVID according to locally approved label. |
Outcome Measures
Primary Outcome Measures
- Proportion of patients with an adverse event (AE) [Baseline through Day 33]
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.
- Proportion of patients with an adverse drug reaction (ADR) [Baseline through Day 33]
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.
- Proportion of patients with a serious AE (SAE) [Baseline through Day 33]
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.
- Proportion of patients with a serious ADR (SADR) [Baseline through Day 33]
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.
- Proportion of patients with an unexpected AE (UAE) [Baseline through Day 33]
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.
- Proportion of patients with an unexpected ADR (UADR) [Baseline through Day 33]
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.
- Proportion of patients with a serious unexpected AE (SUAE) [Baseline through Day 33]
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.
- Proportion of patients with a serious unexpected ADR (SUADR) [Baseline through Day 33]
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.
- Proportion of COVID-19-related hospitalization from any cause [Baseline through Day 33]
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.
- Proportion of COVID-19-related death from any cause [Baseline through Day 33]
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.
- Proportion of subjective assessment of COVID-19-related symptomatic change [Day 5, Day 14, Day 33]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adult and pediatric patients (12 years of age and older weighing at least 40 kg) with mild-to-moderate COVID-19 symptoms, positive results of viral testing (e.g., PCR tests), and who are at high risk for progression to severe COVID-19, including hospitalization or death.
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Patients who received, are currently receiving, or are going to receive PAXLOVID according to locally approved label.
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Patients (or a legally acceptable representative) who are willing to provide written informed consent/assent prior to study enrollment.
Exclusion Criteria:
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Patients with contraindication according to locally approved label of PAXLOVID.
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Patients who are going to receive any investigational medicine during the observation period.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- C4671020