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New registry tracks COVID drug safety for pregnant women and their babies

NCT ID NCT05013632

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This registry is following 2,000 pregnant women who took antiviral drugs or monoclonal antibodies for COVID-19. Researchers will compare their pregnancy and baby outcomes to those who did not receive these treatments. The goal is to better understand the safety of these medications during pregnancy.

What this could mean

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

Active substance
antiviral drugs (remdesivir, molnupiravir) and monoclonal antibodies (casirivimab/imdevimab, sotrovimab)
What this could lead to
If successful, this registry could provide crucial safety data on COVID-19 treatments during pregnancy, helping doctors make informed decisions.
What could go wrong
This is an observational registry, not a controlled trial, so it cannot prove cause and effect. Results may take years and depend on accurate reporting.

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

About 2,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2021

Expected to finish

Sep 2027

An estimate. End dates often move.

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 exposed study population consists of pregnant or recently pregnant women 18 years of age and older treated with at least one dose of a monoclonal antibody or antiviral drug indicated for COVID-19 from first day of the LMP to end of pregnancy. For monoclonal antibodies, the exposure period also includes 90 days prior to the first day of the LMP. The reference groups include pregnant women not exposed to monoclonal antibodies or antiviral drugs and treated with another therapy for mild, moderate, or severe COVID-19 (active comparator) and women who experienced COVID-19 during pregnancy and were hospitalized but were not treated with a medication specifically indicated for mild, moderate, or severe COVID-19 (unexposed comparator), matched by calendar time, country of residence, gestational timing at the time of COVID-19 infection (± 2 weeks), and severity of COVID-19.

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: * Pregnant or recently pregnant (up to 30 days after the end of pregnancy) at time of enrollment * Age ≥18 years at time of enrollment * With mild to severe COVID-19 during pregnancy * Either * Treated for COVID-19 with at least one of the medications included in Table 1 during pregnancy. For monoclonal antibodies, the exposure period also includes 90 days prior to the first day of the LMP or * Hospitalized and did not receive any pharmacological treatment specifically indicated for mild, moderate, or severe COVID-19 during pregnancy * Resident of a country where a Central Institutional Review Board (IRB) or Ethics Committee provided approval to conduct the study or clearance that approval is not required to conduct the study * Signed the informed consent form and submitted the baseline module "COVID-19 Medications During This Pregnancy" Exclusion Criteria: ● \<18 years of age

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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.

COVID19

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Pregistry

    RECRUITING

    Los Angeles, California, 90045, United States

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