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Completed

NCT Number: NCT05263908

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

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.

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Key information

Conditions

Sars-CoV-2 Infection COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer Local County

Tokyo, 1518589, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

nirmatrelvir / ritonavir

Drug

The usual dosage in adults and pediatric patients (≥12 years of age weighing ≥40 kg) is 300 mg of Nirmatrelvir and 100 mg of ritonavir all taken together orally twice daily for 5 days.

Other names: PAXLOVID PACK

Primary outcomes

  1. Incidence of Adverse Drug Reactions

    Time frame: 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 outcomes

  1. Percentage of Participants With Worsening Severity (Efficacy Analysis Set #1)

    Time frame: 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."

  2. Percentage of Participants With Worsening Severity (Efficacy Analysis Set #2)

    Time frame: 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."

  3. Percentage of Participants With Worsening Severity (Efficacy Analysis Set #3)

    Time frame: 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."

  4. Cumulative Incidence Rate of COVID-19 Related Hospitalization or Death From Any Cause Through Day 28 (Efficacy Analysis Set #3)

    Time frame: 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.

  5. Cumulative Incidence Rate of COVID-19 Related Hospitalization or Death From Any Cause Through Day 28 (Sensitivity Analysis) (Efficacy Analysis Set #3)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

General Investigation for PAXLOVID PAC

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 3, 2022
Registry last updated
Sep 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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