ClinicalTrials.Veeva

Menu

In Utero Exposure to SARS-CoV-2 (COVID-19) and Cardiovascular and Metabolic Endpoints in Early Life (PROSPER)

Mass General Brigham logo

Mass General Brigham

Status

Completed

Conditions

In Utero SARS-CoV-2 Exposure

Treatments

Other: In Utero Exposure to SARS-CoV-2

Study type

Observational

Funder types

Other

Identifiers

NCT04921241
2021P001107

Details and patient eligibility

About

Since its initial outbreak in late 2019, coronavirus disease 2019 (COVID-19) caused by the novel coronavirus SARS-CoV-2 has ravaged the globe, causing illness characterized by inflammation and impaired oxygen levels. As a particularly vulnerable group, pregnant women have had a heightened prevalence and severity of infection. In this context, a new population of children has emerged who were exposed to maternal COVID-19 in the womb. As maternal diseases during pregnancy may impact the health of offspring over the life course, health outcomes among these individuals must be urgently evaluated. In the current study, the investigators will leverage a perinatal biorepository comprised of pregnant women with and without COVID-19 to delineate the metabolic and cardiovascular risk profiles of these offspring. This work stands to benefit the burgeoning population of children exposed to COVID-19 in the womb and to deepen the mechanistic understanding of developmental origins of cardiometabolic disease with respect to maternal infections.

Enrollment

86 patients

Sex

All

Ages

9+ months old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Mother with or without prenatal COVID-19 who was enrolled in the MGH COVID-19 Perinatal Biorepository and her child (9-24 months old)

Exclusion criteria

  • Child with any history of documented COVID-19
  • Mother who received the COVID-19 vaccine during pregnancy with her child
  • Significant chronic illness in mother or child judged by the investigator to represent a contraindication to study participation

Trial design

86 participants in 2 patient groups

SARS-CoV-2 Exposed Dyads
Description:
Mothers who had SARS-CoV-2 during pregnancy and their offspring
Treatment:
Other: In Utero Exposure to SARS-CoV-2
SARS-CoV-2 Unexposed Dyads
Description:
Mothers who were not known to have SARS-CoV-2 during pregnancy and their offspring

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems