Ignite Creation Date:
2025-12-24 @ 2:43 PM
Ignite Modification Date:
2025-12-29 @ 3:42 AM
Study NCT ID:
NCT04659759
Status:
COMPLETED
Last Update Posted:
2025-12-02
First Post:
2020-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
COVID-19 Pregnancy Related Immunological, Clinical and Epidemiological Factors and Perinatal Outcomes
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000086663', 'term': 'COVID-19 Vaccines'}], 'ancestors': [{'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': '* Maternal serum/plasma\n\n * SARS-CoV-2 serology\n * Cytokine/chemokine panel\n* Cord blood serum/plasm\n\n * SARS-CoV-2 serology\n * Cytokine/chemokine panel\n * DNA methylation, miRNA/mRNA exression\n* Breastmilk o SARS-CoV-2 serology'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 105}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-25', 'studyFirstSubmitDate': '2020-12-07', 'studyFirstSubmitQcDate': '2020-12-07', 'lastUpdatePostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-12-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maternal COVID-19 serology (IgG and IgM)', 'timeFrame': '6 weeks post partum', 'description': 'IgG/IgM time profile through pregnancy up to 6 weeks post partum for those exposed to COVID-19'}, {'measure': 'Maternal/neonatal IgG and IgM concordance', 'timeFrame': 'Delivery', 'description': 'IgG/IgM at delivery in mother/neonate through maternal and cord blood sampling'}, {'measure': 'Maternal COVID serology time/profile following vaccination', 'timeFrame': '6 months', 'description': 'Baseline, 1m, 3m, 6m post second vaccine dose'}, {'measure': 'Breastmilk Serology', 'timeFrame': '6months', 'description': 'Breastmilk IgG and IgA time profile following COVID vaccine in breastfeeding women'}], 'secondaryOutcomes': [{'measure': 'Breastmilk Serology', 'timeFrame': 'Delivery', 'description': 'COVID-19 IgG and IgA in breast milk'}, {'measure': 'Breastmilk Serology', 'timeFrame': '6 weeks post partum', 'description': 'COVID-19 IgG and IgA in breastmilk'}, {'measure': 'Cytokine', 'timeFrame': 'Delivery', 'description': 'Compare maternal COVID (+) and COVID (-) cytokine panel'}, {'measure': 'Neonatal cytokine', 'timeFrame': 'Delivery', 'description': 'Compare cordblood cytokine panel between COVID(+) and COVID (-) at delivery'}, {'measure': 'COVID disease vs vaccination immune response', 'timeFrame': '6 months', 'description': 'Compare maternal IgG concentration time/profile in those with COVID disease vs COVID vaccine'}, {'measure': 'COVID vaccine in pregnant vs nonpregnant', 'timeFrame': '6 months', 'description': 'Compare maternal IgG concentration/time profile in pregnant vs non-pregnant women with vaccine'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Covid19']}, 'descriptionModule': {'briefSummary': 'This is a prospective cohort study of pregnant patients at an urban academic center diagnosed with perinatal COVID-19 infection, followed up to 6 weeks postpartum.', 'detailedDescription': 'This proposal aims to provide a multi-faceted approach to addressing perinatal COVID-19 infection by (1) improving our understanding of SARS-CoV-2 antibody specificity and durability over the course of pregnancy/postpartum in mother/baby dyad (2) understanding the downstream implications of maternal systemic inflammatory response with COVID-19 infection through study of fetal inflammatory response, placental pathology, and perinatal outcomes, and (3) to evaluate the interplay between socioeconomic characteristics, COVID-19, and early neonatal outcomes. (4) Evaluate antibody generation and durability in pregnant/breastfeeding women who receive any form of the COVID-19 vaccine'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pregnant patients diagnosed with COVID-19 at any point during pregnancy or within 6 weeks post partum', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of COVID-19 in pregnancy or within 6 months post partum\n* Planned delivery at Thomas Jefferson University Hospital\n\nExclusion Criteria:\n\n* Declines routine COVID testing on admission\n* In active labor/pain/otherwise unable to provide consent'}, 'identificationModule': {'nctId': 'NCT04659759', 'acronym': 'COVID-PRICE', 'briefTitle': 'COVID-19 Pregnancy Related Immunological, Clinical and Epidemiological Factors and Perinatal Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'Thomas Jefferson University'}, 'officialTitle': 'COVID-19 in Pregnancy: Utilizing Immunology Through Epidemiology to Improve Perinatal/Neonatal Outcomes', 'orgStudyIdInfo': {'id': '20F.1043'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'COVID-19 Positive', 'description': 'Patients diagnosed with COVID-19 during pregnancy or while breastfeeding', 'interventionNames': ['Other: COVID-19 exposure']}, {'label': 'COVID-19 vaccine', 'description': 'Patients who receive COVID-19 vaccine during pregnancy or while breastfeeding', 'interventionNames': ['Biological: COVID-19 vaccine']}, {'label': 'Controls', 'description': 'Reproductive age women exposed to COVID-19 vaccine'}, {'label': 'Pregnant Control', 'description': 'Pregnant women who delivered at TJUH, COVID negative'}], 'interventions': [{'name': 'COVID-19 exposure', 'type': 'OTHER', 'description': 'COVID-19 exposure during pregnancy', 'armGroupLabels': ['COVID-19 Positive']}, {'name': 'COVID-19 vaccine', 'type': 'BIOLOGICAL', 'description': 'Receipt of any COVID-19 vaccine', 'armGroupLabels': ['COVID-19 vaccine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University Hospital', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Thomas Jefferson University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Nemours', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}