Clinical trial NCT04362956: Clinical and Immunologic Impact of Perinatal SARS-CoV-2 (COVID-19) Infection
Official title: Clinical and Immunologic Impact of SARS-CoV-2 in Hospitalized Pregnant Women and Neonates in Argentina
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Pregnancy Related
Neonatal Infection
Lead sponsor: Fundacion Infant
Sponsor class: OTHER
First posted: 2020-04-27
Enrollment: 114
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Elegible patients will be all pregnant women of 9 large maternity hospitals in Argentina.

Brief summary: This is a multi-center prospective study that aims to investigate the clinical and immunologic impact of SARS-CoV-2 infection in pregnant women and neonates. The goal is to recruit 200 SARS-CoV-2 infected pregnant women starting at 24 weeks of gestation in a neonatal network of 45.000 birth a year. Clinical data will be collected from women and neonates. Upper airways samples will be obtained from both for bio-markers investigation. Finally, maternal and umbilical cord serum and human milk will be obtained for antibody assessment.

Detailed description: COVID-19, the disease caused by the novel coronavirus SARS-CoV-2, has led to an unprecedented global pandemic affecting persons of all ages. Pregnant women are in a physiologic immunosuppressed situation and have a greater risk and severity of respiratory infection. However, considerable uncertainty exists regarding the potential for vertical transmission (prenatal/congenital or perinatal) of SARS-CoV-2 from infected pregnant women to their newborns and its potential clinical consequences.

This study attempts to provide evidence-based guidelines for managing antenatal, intrapartum, and neonatal care around COVID-19 require an understanding of whether the virus can be transmitted transplacentally; a determination of which maternal body fluids may be infectious; trasnplacental and human milk antibody transfer and data of adequate statistical power that describe which maternal, intrapartum, and neonatal factors influence perinatal transmission.

Eligibility criteria: Inclusion Criteria:

* Pregnant women hospitalized presenting with:

  1. Fever with one or more respiratory symptoms (cough, odinophagia, respiratory difficulty)
  2. Diagnoses of pneumonia with no other explainable cause.

Exclusion Criteria:

* None

Primary outcomes:
measure: Vertical transmission
timeFrame: 96 hours from birth
measure: Neonatal protection due to maternal antibodies
timeFrame: 24 weeks of gestation to birth
Secondary outcomes:
measure: Increase risk of neonatal morbidity
timeFrame: up to 30 days of life
measure: Increase risk of obstetric complications
timeFrame: Up to 14 days of hospitalization
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Hospital Italiano
Study officials:
References:
citation: Larcade R, DeShea L, Lang GA, Caballero MT, Ferretti A, Beasley WH, Tipple TE, Vain N, Prudent L, Lang ML, Polack FP, Ofman G. Maternal-Fetal Immunologic Response to SARS-CoV-2 Infection in a Symptomatic Vulnerable Population: A Prospective Cohort. J Infect Dis. 2022 Mar 2;225(5):800-809. doi: 10.1093/infdis/jiab591.