Last updated: 01/29/2025 10:20:13
COVID-19 International Drug Pregnancy RegistryCOVID-PR
GSK study ID
216978
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Recruiting
Recruiting
Trial overview
Official title: COVID-19 International Drug Pregnancy Registry (COVID-PR)
Trial description: This international, non-interventional, post-marketing cohort study aims to evaluate obstetric, neonatal, and infant outcomes among women who required at least one in-hospital or ambulatory medication for mild to severe coronavirus disease-19 (COVID-19).
Primary purpose:
Treatment
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Number of participants who developed gestational diabetes
Timeframe: Up to 5 years
Number of participants who developed hypertensive disorders during pregnancy
Timeframe: Up to 5 years
Number of participants who developed postpartum hemorrhage
Timeframe: Up to 5 years
Number of participants who underwent cesarean section
Timeframe: Up to 5 years
Number of participants who underwent preterm delivery
Timeframe: Up to 5 years
Number of neonates born with major congenital malformations
Timeframe: Up to 5 years
Number of neonates born with low birth weight
Timeframe: Up to 5 years
Number of neonates born small for their gestational age
Timeframe: Up to 5 years
Number of neonates with abnormal cognitive development at specified time points
Timeframe: Up to 5 years
Number of neonates with abnormal movement and physical development at specified time points
Timeframe: Up to 5 years
Secondary outcomes:
Number of participants experiencing miscarriage
Timeframe: Up to 5 years
Number of participants experiencing stillbirth
Timeframe: Up to 5 years
Number of neonatal deaths
Timeframe: Up to 5 years
Number of maternal deaths
Timeframe: Up to 5 years
Number of neonates admitted in the neonatal intensive care unit (NICU)
Timeframe: Up to 5 years
Number of infants who developed COVID-19 till 1 year of age
Timeframe: Up to 5 years
Number of infants who developed severe infections till 1 year of age
Timeframe: Up to 5 years
Number of participants who developed postpartum depression
Timeframe: Up to 5 years
Number of participants who developed COVID-19 re-infection
Timeframe: Up to 5 years
Number of participants who developed other infections
Timeframe: Up to 5 years
Interventions:
Not applicable
Enrollment:
600
Primary completion date:
2026-01-12
Observational study model:
Cohort
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
COVID-19
Product
sotrovimab
Collaborators
Pregistry, Vir Biotechnology
Study date(s)
January 2022 to December 2026
Type
Observational
Phase
4
Participation criteria
Sex
Female
Age
18+ years
Accepts healthy volunteers
No
- Pregnant women
- Aged 18 years or older
- Not applicable
Inclusion and exclusion criteria
Inclusion criteria:
- Pregnant women
- Aged 18 years or older
- With mild to severe COVID-19 during pregnancy
- Either: was treated for COVID-19 during hospitalization or ambulatory care with at least one of the medications mentioned in the protocol during pregnancy or was hospitalized but not treated with any of the medications mentioned in the protocol
- Living in a country where at least one of the therapies included in the protocol is marketed
- Able and willing to sign the electronic informed consent form agreeing to the conditions and requirements of the COVID-PR
- Willing to upload the minimum required data of the initial baseline questionnaire
Exclusion criteria:
- Not applicable
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Recruiting
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Additional information
Not applicable
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