Registry to evaluate pregnancy outcomes in women treated for COVID-19

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The COVID-19 International Drug Pregnancy Registry aims to assess the effects of monoclonal antibodies and antiviral drugs on obstetric, neonatal, and infant outcomes in pregnant women treated for COVID-19. This observational study will collect data from women from the first day of their last menstrual period until the end of their pregnancy, including a 90-day exposure period for monoclonal antibodies. The study will focus on various outcomes such as spontaneous abortion, congenital malformations, and developmental milestones in infants. By gathering this data, the registry seeks to fill the knowledge gap regarding the safety of these treatments during pregnancy.

Why it matters

Who can join: the full rules

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

Where it's running

• Pregistry
  Los Angeles, California, United States Recruiting

Study contacts

• Principal investigator: Cheryl Renz, MD — Pregistry
• Study coordinator: Cheryl Renz, MD
• Email: covid-pr@pregistry.com
• Phone: 18006163791

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.