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Can paxlovid be safely used in pregnancy? a new trial investigates

NCT ID NCT05386472

Disease control 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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 Aug 17, 2026 · Last updated Aug 18, 2026 · Updated 1 time

Summary

This trial is investigating how the COVID-19 treatment Paxlovid (nirmatrelvir/ritonavir) is absorbed and eliminated by the body, and how well it is tolerated, in pregnant women with mild-to-moderate COVID-19. The study will compare these results to those from non-pregnant women with the same condition. Participants will take Paxlovid by mouth every 12 hours for 5 days, and researchers will monitor safety and side effects throughout the study.

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 could provide crucial safety and dosing data to support using Paxlovid in pregnant women with COVID-19, potentially expanding treatment options for this group.
What could go wrong
This is an early-phase study with a small number of participants, so results may not be conclusive. The safety of the drug during pregnancy is not yet fully established, and there may be risks to the mother or fetus.

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.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

25 people

The number who actually took part.

Started

Jun 2022

Finished

May 2025

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.

Ages

18 to 50 years

Sex

Female participants only

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: * All cohorts: Mild-to-moderate COVID-19 infection confirmed in sample collected ≤5 days prior to enrollment; onset within 5 days prior to enrollment and presence of ≥1 sign/symptom on the day of enrollment. * Cohorts 1\&2: Expecting single baby; Pregnant in 2nd trimester, 14 0/7 to 27 6/7 weeks of gestational age (Cohort 1) or 3rd trimester, ≥28 0/7 and ≤34 6/7 weeks of gestational age (Cohort 2), by ultrasound. * All cohorts: Otherwise healthy participants who are determined by medical history, physical examination, and clinical judgment to be appropriate for inclusion in the study Exclusion Criteria: * All cohorts: Current need for hospitalization or anticipated need for hospitalization in the clinical opinion of the site investigator. * Cohorts 1\&2: Prior/current major condition or illness of mother/fetus substantially increasing risk of study participation/completion or impacting pregnancy/fetal outcomes in investigator's judgement. * All cohorts: Current use of any medications that are highly dependent on CYP3A4 for clearance, and which are contraindicated in combination with nirmatrelvir/ritonavir. * All cohorts: Has received or is expected to receive monoclonal antibody treatment, convalescent COVID-19 plasma, or anti-viral treatment (eg, molnupiravir) for the current SARSCoV-2 infection. * All cohorts: Participants with moderate to severe kidney impairment

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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.

COVID -19

Contacts and locations

Locations

  • Beautiful Minds Clinical Research Center

    Cutler Bay, Florida, 33157, United States

  • Boeson Research MSO

    Missoula, Montana, 59804, United States

  • Clinical Research Prime

    Idaho Falls, Idaho, 83404, United States

  • Maximos Ob/Gyn

    League City, Texas, 77573, United States

  • Omega Research Debary

    DeBary, Florida, 32713, United States

  • Omega Research Orlando

    Orlando, Florida, 32808, United States

  • Origin Health

    Missoula, Montana, 59804, United States

  • Santos Research Center

    Tampa, Florida, 33615, United States

  • University of Alabama at Birmingham/Center for Women's Reproductive Health

    Birmingham, Alabama, 35233, United States

  • University of Utah

    Salt Lake City, Utah, 84108, United States

  • University of Utah

    Salt Lake City, Utah, 84112, United States

  • University of Utah Clinical Neuroscience Center

    Salt Lake City, Utah, 84132, United States

  • University of Utah Hospital

    Salt Lake City, Utah, 84132, United States

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