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PAXLOVID safety under the microscope: 3,300 patients studied

NCT ID NCT05263908

Knowledge-focused Sponsor: Pfizer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This completed study from Pfizer looked at the safety and effects of the COVID-19 medicine PAXLOVID in over 3,300 people aged 12 and older. All participants took PAXLOVID twice a day for five days and were monitored for 28 days. The main goal was to track any side effects, including serious ones. Because this was an observational study, it helps us understand how the drug works in everyday use, but it does not compare PAXLOVID to a placebo or other treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
nirmatrelvir / ritonavir (PAXLOVID)
What this could lead to
If successful, this study could confirm that PAXLOVID is safe and effective for treating COVID-19 in a real-world setting.
What could go wrong
This is an observational study, not a controlled trial, so results may be less reliable. It also only looks at short-term safety over 28 days.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

3,346 people

The number who actually took part.

Started

Mar 2022

Finished

Jul 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The subjects who have been treated with PAXLOVID PACK for the first time.

Ages

12 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

COVID-19

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

SARS-CoV-2 infection

Contacts and locations

Locations

  • Pfizer Local County

    Tokyo, 1518589, Japan

More trials for these conditions

Other studies related to the condition(s) this trial covers.