COVID-19 International Drug Pregnancy Registry (COVID-PR)
Pregistry
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.
Description
Rationale and background: Pharmaceutical companies, academic centers, and other organizations globally are developing monoclonal antibodies and antiviral drugs to treat COVID-19. Pregnant women will be treated with these medications which, for the most part, lack scientific evidence regarding safety for the mother and the developing offspring. Objective: To estimate the effect that monoclonal antibodies and antiviral drugs indicated for mild, moderate, or severe COVID-19 have on obstetric, neonatal, and infant outcomes. Endpoints: Risk of obstetric outcomes (spontaneous abortion, intrauterin…
Eligibility
- Age range
- 18–50 years
- Sex
- Female
- Healthy volunteers
- No
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 Ce…
Interventions
- DrugAntiviral Agents
Antiviral medications indicated for the treatment of mild to severe COVID-19
- DrugMonoclonal antibody
Monoclonal antibodies indicated for the treatment of mild to severe COVID-19
Location
- PregistryLos Angeles, California