Clinical and Immunologic Impact of Perinatal SARS-CoV-2 (COVID-19) Infection
1 other identifier
observational
114
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 21, 2020
CompletedFirst Posted
Study publicly available on registry
April 27, 2020
CompletedStudy Start
First participant enrolled
July 10, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2020
CompletedMarch 12, 2025
February 1, 2021
3 months
April 21, 2020
March 10, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Vertical transmission
Presence of IgM in Umbilical Cord or presence of virus in human milk with infected neonate
96 hours from birth
Neonatal protection due to maternal antibodies
Presence of IgG in umbilical cord
24 weeks of gestation to birth
Secondary Outcomes (2)
Increase risk of neonatal morbidity
up to 30 days of life
Increase risk of obstetric complications
Up to 14 days of hospitalization
Eligibility Criteria
Elegible patients will be all pregnant women of 9 large maternity hospitals in Argentina.
You may qualify if:
- Pregnant women hospitalized presenting with:
- Fever with one or more respiratory symptoms (cough, odinophagia, respiratory difficulty)
- Diagnoses of pneumonia with no other explainable cause.
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fundacion Infantlead
Study Sites (1)
Hospital Italiano
Buenos Aires, 1420, Argentina
Related Publications (1)
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.
PMID: 34865064DERIVED
Biospecimen
Nasopharyngeal aspirates Maternal serum Umbilical Cord serum Human milk
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 21, 2020
First Posted
April 27, 2020
Study Start
July 10, 2020
Primary Completion
October 1, 2020
Study Completion
October 1, 2020
Last Updated
March 12, 2025
Record last verified: 2021-02