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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: f
View:

• 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

Locations
United States
California
Pregistry
RECRUITING
Los Angeles
Contact Information
Primary
Cheryl Renz, MD
covid-pr@pregistry.com
18006163791
Time Frame
Start Date: 2021-12-01
Estimated Completion Date: 2027-09-30
Participants
Target number of participants: 2000
Treatments
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
Authors
Diego Wyszynski
Sponsors
Leads: Pregistry

This content was sourced from clinicaltrials.gov