CompletedNot Applicable

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

Japan3,346 participantsStarted 2022-03-31

Plain-language 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.

Who can participate

Age range

12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of Adverse Drug Reactions

Timeframe: From the start date of treatment with Paxlovid PACK to 28 days after the end of treatment, up to approximately 45 days.

Trial details

NCT IDNCT05263908

SponsorPfizer

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-07-10

Results submitted2024-07-09

View on ClinicalTrials.gov More SARS-CoV-2 Infection trials