COVID-19 International Drug Pregnancy Registry

Part of paid clinical trials in Los Angeles, California.

Sponsor
Pregistry
Study ID
NCT05013632
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • Antiviral Agents — DRUG
    Antiviral medications indicated for the treatment of mild to severe COVID-19
  • Monoclonal antibody — DRUG
    Monoclonal antibodies indicated for the treatment of mild to severe COVID-19

Study Details

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.

Key Dates

Start date
Dec 1, 2021
Status verified
Sep 2025
Primary completion
Sep 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
2,000 participants (estimated)

Arms

  • Arm: 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.
  • Arm: Active comparator pregnant women
    Pregnant women treated with another therapy for mild, moderate, or severe COVID-19
  • Arm: Unexposed pregnant women
    Pregnant women hospitalized but not treated with a medication specifically indicated for the treatment of mild, moderate, or severe COVID-19

Primary Outcome Measure

Obstetric outcomes [ Time Frame: 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
PregistryLos AngelesCalifornia90045
Cheryl Renz, MD
Cheryl Renz, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Los Angeles, CA

By condition
COVID-19 / long COVID
By specialty
Infectious disease
By research site
Pregistry· Los Angeles, CA

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