Clinical and Immunologic Impact of Perinatal SARS-CoV-2 (COVID-19) Infection

Sponsor

Fundacion Infant (Other)

Overall Status

Completed

CT.gov ID

NCT04362956

Collaborator

(none)

114

Enrollment

Location

2.7

Actual Duration (Months)

41.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Covid19 Pregnancy Related Neonatal Infection

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.

Study Design

Study Type:

Observational

Actual Enrollment :

114 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Clinical and Immunologic Impact of SARS-CoV-2 in Hospitalized Pregnant Women and Neonates in Argentina

Actual Study Start Date :

Jul 10, 2020

Actual Primary Completion Date :

Oct 1, 2020

Actual Study Completion Date :

Oct 1, 2020

Outcome Measures

Primary Outcome Measures

Vertical transmission [96 hours from birth]
Presence of IgM in Umbilical Cord or presence of virus in human milk with infected neonate
Neonatal protection due to maternal antibodies [24 weeks of gestation to birth]
Presence of IgG in umbilical cord

Secondary Outcome Measures

Increase risk of neonatal morbidity [up to 30 days of life]
Respiratory distress, hypothermia, poor feeding and others
Increase risk of obstetric complications [Up to 14 days of hospitalization]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Inclusion Criteria:

Pregnant women hospitalized presenting with:

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

Exclusion Criteria:

None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Italiano	Buenos Aires		Argentina	1420

Sponsors and Collaborators

Fundacion Infant

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gaston Ofman, Assistant professor of pediatrics, University of Oklahoma

ClinicalTrials.gov Identifier:

NCT04362956

Other Study ID Numbers:

Perinatal COVID-19

First Posted:

Apr 27, 2020

Last Update Posted:

Feb 9, 2021

Last Verified:

Feb 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Infections

COVID-19

Study Results

No Results Posted as of Feb 9, 2021