A Study to Learn About PAXLOVID (a Commercial Medicine) In People With COVID-19

Completed

Conditions: SARS-CoV-2 Infection

Interventions: Drug: nirmatrelvir / ritonavir

Registration Number: NCT05263908

Lead Sponsor: Pfizer

Brief Summary: The purpose of this post marketing observational study is to learn about the safety and effects of the commercial medicine (called PAXLOVID) for the treatment of COVID-19. This study is intended to be registered with the participants who:

* Have taken PAXLOVID PACK and have no history of using this medicine.

* Are 12 years and older

All participants will receive PAXLOVID, a standard treatment for COVID-19. Participants will take PAXLOVID 2 times a day by mouth or as prescribed.

We will examine the experiences of people taking PAXLOVID. This will help us determine if PAXLOVID is safe and effective.

Participants will be followed up for 28 days after taking PAXLOVID. During this time, participants will be closely watched for the safety and effects of PAXLOVID.

Detailed Description: This is a multicenter cohort study to be conducted in individuals with SARS-CoV-2 infection who are treated with this product, and the investigator will enter the information required in this study in the case report forms (CRFs) based on the information obtained through medical records.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 3346

Inclusion Criteria

Subjects who are administered PAXLOVID PACK and have no history of using this drug.

Exclusion Criteria

There are no exclusion criteria for this study.

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PAXLOVID PACK	nirmatrelvir / ritonavir	Subjects administered PAXLOVID PACK

Primary Outcome Measures

Name	Time	Method
Incidence of Adverse Drug Reactions	From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45 days.	Adverse drug reaction (ADR) was a treatment-related adverse event and any untoward medical occurrence attributed to Paxlovid PACK in a participant who received Paxlovid PACK. Serious adverse drug reaction (SADR) was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Relatedness to Paxlovid PACK was assessed by the physician.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Worsening Severity (Efficacy Analysis Set #1)	From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45 days.	Whether the severity of infection caused by SARS-CoV-2 had worsened was evaluated. However, when the severity was severe at the start of Paxlovid PACK and did not worsen during the observation period, it was considered as "severe at the start of treatment."
Percentage of Participants With Worsening Severity (Efficacy Analysis Set #2)	From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 35 days.	Whether the severity of infection caused by SARS-CoV-2 had worsened was evaluated. However, when the severity was severe at the start of Paxlovid PACK and did not worsen during the observation period, it was considered as "severe at the start of treatment."
Percentage of Participants With Worsening Severity (Efficacy Analysis Set #3)	From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 35 days.	Whether the severity of infection caused by SARS-CoV-2 had worsened was evaluated. However, when the severity was severe at the start of Paxlovid PACK and did not worsen during the observation period, it was considered as "severe at the start of treatment."
Cumulative Incidence Rate of COVID-19 Related Hospitalization or Death From Any Cause Through Day 28 (Efficacy Analysis Set #3)	3, 5, 7, 14, 21 and 28 days after the start of administration with Paxlovid PACK.	The percent probability is the percent of the participants who had COVID-19 related hospitalization or death from any cause.
Cumulative Incidence Rate of COVID-19 Related Hospitalization or Death From Any Cause Through Day 28 (Sensitivity Analysis) (Efficacy Analysis Set #3)	3, 5, 7, 14, 21 and 28 days after the start of administration with Paxlovid PACK.	The percent probability is the percent of the participants who had COVID-19 related hospitalization or death from any cause. Sensitivity analysis was conducted by changing the event definition of "hospitalization for treatment of infection caused by SARS-CoV-2" as follows: there were concomitant medications for infection caused by SARS-CoV-2 or concomitant non-drug therapies due to infection caused by SARS-CoV-2 on or after the date of administration.