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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04362956
• Other study ID #: Perinatal COVID-19
• Status: Completed
• Start date: July 10, 2020
• Est. completion date: October 1, 2020

Study information

• Verified date: February 2021
• Source: Fundacion Infant
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: October 1, 2020
• Est. primary completion date: October 1, 2020
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Covid19
• Infection
• Neonatal Infection
• Pregnancy Related

Locations

Country	Name	City	State
Argentina	Hospital Italiano	Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
Fundacion Infant

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vertical transmission	Presence of IgM in Umbilical Cord or presence of virus in human milk with infected neonate	96 hours from birth
Primary	Neonatal protection due to maternal antibodies	Presence of IgG in umbilical cord	24 weeks of gestation to birth
Secondary	Increase risk of neonatal morbidity	Respiratory distress, hypothermia, poor feeding and others	up to 30 days of life
Secondary	Increase risk of obstetric complications		Up to 14 days of hospitalization