COVID-19 International Drug Pregnancy Registry
ConditionCovid19
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-50
SponsorPregistry
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial population
The exposed study population consists of pregnant or recently pregnant women 18 years of age and older treated with at least one dose of a monoclonal antibody or antiviral drug indicated for COVID-19 from first day of the LMP to end of pregnancy. For monoclonal antibodies, the exposure period also includes 90 days prior to the first day of the LMP. The reference groups include pregnant women not exposed to monoclonal antibodies or antiviral drugs and treated with another therapy for mild, moderate, or severe COVID-19 (active comparator) and women who experienced COVID-19 during pregnancy and were hospitalized but were not treated with a medication specifically indicated for mild, moderate, or severe COVID-19 (unexposed comparator), matched by calendar time, country of residence, gestational timing at the time of COVID-19 infection (± 2 weeks), and severity of COVID-19.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Antiviral Agents
DrugAntiviral medications indicated for the treatment of mild to severe COVID-19
Monoclonal antibody
DrugMonoclonal antibodies indicated for the treatment of mild to severe COVID-19
Treatment groups
2,000 Participants
are divided into 3 treatment groupsGroup A: Exposed pregnant women2 interventions
Group B: Active comparator pregnant women0 interventions
Group C: Unexposed pregnant women0 interventions
Trial outcomes
Primary outcomes
1
Obstetric outcomes
Number of pregnant women who received at least one dose of a monoclonal antibody or antiviral drug indicated for the treatment of mild, moderate, or severe COVID-19 and number of pregnant women in the reference cohorts who experience spontaneous abortion, intrauterine growth restriction, gestational diabetes, gestational hypertension, postpartum hemorrhage, Caesarean delivery.
Time frame
1 year2
Neonatal outcomes
Number of newborns of women who received at least one dose of a monoclonal antibody or antiviral drug indicated for the treatment of mild, moderate, or severe COVID-19 and number of newborns of pregnant women in the reference cohorts who experience major congenital malformations, low birth weight, small for gestational age, neonatal infections, stillbirth, neonatal death, preterm birth.
Time frame
1 year3
Infant weight
Change in weight from birth to 3, 6, 9, and 12 months of age among newborns of women who received at least one dose of a monoclonal antibody or antiviral drug indicated for the treatment of mild, moderate, or severe COVID-19 and among newborns of pregnant women in the reference cohorts.
Time frame
1 year4
Infant developmental milestones
Change in developmental milestones from baseline at 6, 9, and 12 months based on the tool Caregiver Reported Early Development Instruments among the offspring of women who received at least one dose of a monoclonal antibody or antiviral drug indicated for the treatment of mild, moderate, or severe COVID-19 and among the offspring of pregnant women in the reference cohorts.
Time frame
1 year Source ClinicalTrials.gov