Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-26 @ 4:34 AM
Study NCT ID:
NCT05092594
Status:
UNKNOWN
Last Update Posted:
2022-04-12
First Post:
2021-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prognostic Value of IgM in 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_WITH_DNA', 'description': 'Blood sampling between day 1 to day 14 from first syndromes of Covid-19 infection. Serum or plasma conservations.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-04', 'studyFirstSubmitDate': '2021-10-01', 'studyFirstSubmitQcDate': '2021-10-22', 'lastUpdatePostDateStruct': {'date': '2022-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hospitalization', 'timeFrame': 'through study completion, an average of 1 month', 'description': 'Absence of hospitalization versus hospitalization without ventilation during SARS-CoV-2 infection'}, {'measure': 'Ventilation', 'timeFrame': 'through study completion, an average of 1 month', 'description': 'Non ventilation versus ventilation during Covid-19 hospitalization'}], 'secondaryOutcomes': [{'measure': 'Hospitalization at Ambroise Paré hospital', 'timeFrame': 'through study completion, an average of 1 month', 'description': 'Hospitalization at Ambroise Paré hospital during SARS-CoV-2 infection'}, {'measure': 'Oxygenotherapy', 'timeFrame': 'through study completion, an average of 1 month', 'description': 'Use of high-flow oxygenotherapy'}, {'measure': 'Ventilation', 'timeFrame': 'through study completion, an average of 1 month', 'description': 'Ventilation during SARS-CoV-2 infection'}, {'measure': 'Thoracic CT', 'timeFrame': 'through study completion, an average of 1 month', 'description': 'Thoracic CT result during SARS-CoV-2 infection'}, {'measure': "Patient's vital statute", 'timeFrame': 'through study completion, an average of 1 month', 'description': 'Death of hospitalized patients in Ambroise Paré hospital'}, {'measure': 'IgM anti-SARS-Co-V-2 presence', 'timeFrame': 'through study completion, an average of 1 month', 'description': 'IgM anti-SARS-Co-V-2 level'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Covid-19', 'anti SARS-Co-V-2 IgM'], 'conditions': ['COVID-19']}, 'descriptionModule': {'briefSummary': 'The primary objective of the research is to study the relation between the presence and /or the anti SARS-Co-V-2 IgM level in an early stage of COVID-19 infection, and the evolution of the illness.', 'detailedDescription': 'The secondary objective is to determinate in what manner response of IgM anti-SARS-Co-V-2 relates to patient\'s immunity statute, in regards to the other so-called humain "seasonal coronavirus".'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult SARS-CoV-2 positive patients who have blood sampling between 1 day and 14 days from the first clinical syndromes and their collections of serum or plasma are accessible.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients ≥ 18 years;\n* Have been diagnosed positive of SARS-CoV-2 in the Virological Laboratory of Ambroise Paré hospital;\n* Have been blood sampled between 1 day and 14 days from the first clinical syndromes, and their collections of serum or plasma are conserved and accessible;\n* Affiliated to the social security scheme or entitled;\n* Informed and non-opposed to participating to the study.\n\nExclusion Criteria:\n\n* Opposition of patient to participation to the study;\n* Foreign patients under french AME scheme.'}, 'identificationModule': {'nctId': 'NCT05092594', 'acronym': 'COVID-M', 'briefTitle': 'Prognostic Value of IgM in Covid-19 Infection', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'The Prognostic Value of IgM in Covid-19 Infection', 'orgStudyIdInfo': {'id': '21JGD-COVIDM'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Jean-Louis Gaillard, MD, PhD', 'role': 'CONTACT', 'email': 'jean-louis.gaillard@aphp.fr', 'phone': '+ 33 (0)1 49 09 55 40'}], 'overallOfficials': [{'name': 'Jean-Louis Gaillard, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Microbiological Laboratory - CHU Ambroise Paré - APHP'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}