Recruiting

Observational Study

Sponsor:

Pregistry

Code:

NCT05013632

Conditions

Covid19

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Not accepted

Interventions

Antiviral Agents

Monoclonal antibody

Study Details

Brief summary:

The objective of the COVID-19 International Drug Pregnancy Registry (COVID-PR) is to evaluate obstetric, neonatal, and infant outcomes among women treated with monoclonal antibodies or antiviral drugs indicated for mild, moderate, or severe COVID-19 from the first day of the last menstrual period (LMP) to end of pregnancy. For monoclonal antibodies, the exposure period also includes 90 days prior to the first day of the LMP.

Conditions

Covid19

Study ID

NCT05013632

Start date

Dec 1, 2021

Status verified date

Sep, 2025

Completion date

Sep 30, 2027

Anticipated

Primary completion date

Sep 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

2000 participants

Anticipated

Interventions and Outcome Measures

Arms

Exposed pregnant women

Pregnant or recently pregnant women 18 years of age and older treated with monoclonal antibodies or antiviral drugs indicated for mild, moderate, or severe COVID-19 at any time during pregnancy. For monoclonal antibodies, the exposure period also includes 90 days prior to the first day of the LMP.

Active comparator pregnant women

Pregnant women treated with another therapy for mild, moderate, or severe COVID-19

Unexposed pregnant women

Pregnant women hospitalized but not treated with a medication specifically indicated for the treatment of mild, moderate, or severe COVID-19

Interventions

Antiviral Agents

Antiviral medications indicated for the treatment of mild to severe COVID-19

Monoclonal antibody

Monoclonal antibodies indicated for the treatment of mild to severe COVID-19

Primary outcome measure

  • Obstetric outcomes [ Time Frame: 1 year ]
  • Neonatal outcomes [ Time Frame: 1 year ]
  • Infant weight [ Time Frame: 1 year ]
  • Infant developmental milestones [ Time Frame: 1 year ]
  • Infant height [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Cheryl Renz, MD

18006163791covid-pr@pregistry.com

Locations

Pregistry

Recruiting

Los Angeles, California, United States, 90045

Principal Investigator:

Cheryl Renz, MD

More Information

Sponsor

Pregistry

Last update posted

Sep 26, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Pregistry on 2025-09-26.