Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-25 @ 9:21 PM
Study NCT ID:
NCT04362956
Status:
COMPLETED
Last Update Posted:
2025-03-12
First Post:
2020-04-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical and Immunologic Impact of Perinatal SARS-CoV-2 (COVID-19) Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Nasopharyngeal aspirates Maternal serum Umbilical Cord serum Human milk'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 114}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-10', 'studyFirstSubmitDate': '2020-04-21', 'studyFirstSubmitQcDate': '2020-04-23', 'lastUpdatePostDateStruct': {'date': '2025-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vertical transmission', 'timeFrame': '96 hours from birth', 'description': 'Presence of IgM in Umbilical Cord or presence of virus in human milk with infected neonate'}, {'measure': 'Neonatal protection due to maternal antibodies', 'timeFrame': '24 weeks of gestation to birth', 'description': 'Presence of IgG in umbilical cord'}], 'secondaryOutcomes': [{'measure': 'Increase risk of neonatal morbidity', 'timeFrame': 'up to 30 days of life', 'description': 'Respiratory distress, hypothermia, poor feeding and others'}, {'measure': 'Increase risk of obstetric complications', 'timeFrame': 'Up to 14 days of hospitalization'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Covid19', 'Pregnancy Related', 'Neonatal Infection']}, 'referencesModule': {'references': [{'pmid': '34865064', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Elegible patients will be all pregnant women of 9 large maternity hospitals in Argentina.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women hospitalized presenting with:\n\n 1. Fever with one or more respiratory symptoms (cough, odinophagia, respiratory difficulty)\n 2. Diagnoses of pneumonia with no other explainable cause.\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT04362956', 'briefTitle': 'Clinical and Immunologic Impact of Perinatal SARS-CoV-2 (COVID-19) Infection', 'organization': {'class': 'OTHER', 'fullName': 'Fundacion Infant'}, 'officialTitle': 'Clinical and Immunologic Impact of SARS-CoV-2 in Hospitalized Pregnant Women and Neonates in Argentina', 'orgStudyIdInfo': {'id': 'Perinatal COVID-19'}}, 'contactsLocationsModule': {'locations': [{'zip': '1420', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Hospital Italiano', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundacion Infant', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}