COVID-19 International Drug Pregnancy Registry

Description

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

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Study Overview

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Study Details

Study overview

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.

COVID-19 International Drug Pregnancy Registry (COVID-PR)

COVID-19 International Drug Pregnancy Registry

Condition
Covid19
Intervention / Treatment

-

Contacts and Locations

Los Angeles

Pregistry, Los Angeles, California, United States, 90045

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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"

Ages Eligible for Study

18 Years to 50 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Pregistry,

Diego Wyszynski, MD, MHS, PhD, PRINCIPAL_INVESTIGATOR, Pregistry

Study Record Dates

2027-09-30