Not provided
Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCT05890612 | Registry Identifier | ClinicalTrials.gov |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants receiving PAXLOVID | Participants receiving PAXLOVID according to locally approved label. |
Not provided
| 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. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients who received, are currently receiving, or are going to receive PAXLOVID according to locally approved label.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pfizer CT.gov Call Center | Contact | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Korea | Recruiting | Seoul | 04631 | South Korea |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |