COVID-19
Conditions
Keywords
severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), PAXLOVID, post marketing surveillance (PMS), Korea
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.
Interventions
None listed
Sponsors
Pfizer
Study design
Observational model
CASE_ONLY
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
South Korea
Contacts
CONTACTPfizer CT.gov Call Center
STUDY_DIRECTORPfizer CT.gov Call Center
Pfizer
Outcome results
None listed