Ignite Creation Date:
2025-12-24 @ 4:51 PM
Ignite Modification Date:
2025-12-25 @ 2:35 PM
Study NCT ID:
NCT04347850
Status:
UNKNOWN
Last Update Posted:
2020-07-08
First Post:
2020-04-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Cohort of Patients With Possible or Confirmed SARS-CoV-2 (COVID-19)
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': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Plasma, serum, total blood, urine, stool, oral fluid'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2022-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-06', 'studyFirstSubmitDate': '2020-04-09', 'studyFirstSubmitQcDate': '2020-04-13', 'lastUpdatePostDateStruct': {'date': '2020-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of confirmed COVID-19', 'timeFrame': '1 day', 'description': 'Number of confirmed COVID-19'}], 'secondaryOutcomes': [{'measure': 'Number of severe COVID-19', 'timeFrame': '1 day', 'description': 'Number of severe COVID-19'}, {'measure': 'Identification and validation of predictive biomarkers of a poorer respiratory evolution associated with positive testing for SARS-CoV-2 infection', 'timeFrame': '1 day', 'description': 'CORO-TRI substudy'}, {'measure': 'Evaluate the morbidity and mortality and these risk factors linked to Covid-19 in the congenital heart disease population in France', 'timeFrame': '1 day', 'description': 'COVID-CHD substudy'}, {'measure': 'Identify the characteristics of physiotherapy care for patients with COVID-19 in intensive care', 'timeFrame': '1 day', 'description': 'Physio-Covid substudy'}, {'measure': 'To assess the accuracy and prognostic performance of clinical and biological parameters measured on admission to the emergency department to stratify patients suspected of COVID-19', 'timeFrame': '1 day', 'description': 'Covida substudy'}, {'measure': 'Evaluate diagnostic tests for olfactory function in relation to the RT-PCR procedure', 'timeFrame': '1 day', 'description': 'Olfa-covid substudy'}, {'measure': 'Assessment of Extra Vascular Lung Water and Pulmonary Permeability by transpulmonary thermodilution in critically ill patients with Coronavirus Disease 2019 pneumonia under invasive mechanical ventilation', 'timeFrame': '1 day', 'description': 'PiCCOVID substudy'}, {'measure': 'Description of trans pulmonary motor pressure in COVID 19+ patients in severe stage in intensive care', 'timeFrame': '1 day', 'description': 'TRANSPULMONARY-COVID19 substudy'}, {'measure': 'Immuno-monitoring of COVID-19 positive patients', 'timeFrame': '1 day', 'description': 'CytoCOVID substudy'}, {'measure': 'Characterization in clinical proteomics of the SARS-CoV-2 spike protein', 'timeFrame': '1 day', 'description': 'ProteoCOVID substudy'}, {'measure': 'Diagnosis of endocrine dysfunctions in Covid-19', 'timeFrame': '1 day', 'description': 'Dyhor-19 substudy'}, {'measure': 'describe the occurrence of Covid19 infection in patients with systemic lupus erythematosus treated with hydroxychloroquine over the long term', 'timeFrame': '1 day', 'description': 'Lupus substudy'}, {'measure': 'Acral cutaneous thrombotic vasculopathy and Covid-19 infection : search for acquired thrombophilia and interferon-alpha signature', 'timeFrame': '1 day', 'description': 'Vasculopathy substudy'}, {'measure': 'Evaluation of a COVID-19 screening strategy combining chest low dose CT and RT-PCR test for patients admitted for surgical or interventional procedures during the COVID 19 outbreak', 'timeFrame': '1 day', 'description': 'COVID-Scan study'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['presence of COVID-19 symptoms', 'COVID-19 infection'], 'conditions': ['SARS-CoV-2', 'COVID-19']}, 'referencesModule': {'references': [{'pmid': '38180230', 'type': 'DERIVED', 'citation': 'Capelli N, Domitien Payet L, Alcocer Cordellat C, Pisoni A, Engelmann I, Van de Perre P, Jeziorski E, Tuaillon E. SARS-CoV-2 nucleocapsid antigen in plasma of children hospitalized for COVID-19 or with incidental detection of SARS-CoV-2 infection. J Med Virol. 2024 Jan;96(1):e29358. doi: 10.1002/jmv.29358.'}]}, 'descriptionModule': {'briefSummary': 'SARV-CoV-2 infection was considered pandemic on March 11, 2020. The SARV-CoV-2 epidemic affected France from the beginning of March, spreading in particular from a 4-day large evangelical meeting of 2500 people on February 17 in the city of Mulhouse (North East of France). The Montpellier University Hospital has set up a clinical pathway for people suspected of being infected with SARV-CoV-2 because of signs compatible with pneumonia (screening criteria in France during the study period). This includes an emergency department, an infectious disease department dedicated to the surveillance of infected people requiring hospital treatment, and an intensive care unit for the most severe cases. The diagnosis of infection with SARV-CoV-2 was confirmed in approximately 20% of people initially referred in this special care system.\n\nThe main objective of this cohorte is the collection of clinical data and biological samples from care for non-interventional research on the patients with a possible or confirmed SARS-CoV -2 infection, from diagnosis to long-term follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with a possible or confirmed SARS-CoV -2 infection, from diagnosis to long-term follow-up.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n\\- Patients care at the Montpellier University Hospital suspected of a COVID-19 infection\n\nExclusion criteria:\n\n* Patient opposed to the use of his data for research purposes\n* Patient deprived of liberty by judicial decision\n* Patient not affiliated to a social security scheme'}, 'identificationModule': {'nctId': 'NCT04347850', 'acronym': 'COVIDothèque', 'briefTitle': 'A Cohort of Patients With Possible or Confirmed SARS-CoV-2 (COVID-19)', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'A Cohort of Patients With Possible or Confirmed SARS-CoV-2 (COVID-19) Infection, From Diagnosis to Long-term Follow-up', 'orgStudyIdInfo': {'id': 'RECHMPL20_0185'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patient with Covid-19 confirmed (middle form)', 'description': 'Covid-19 confirmed: middle form', 'interventionNames': ['Other: blood sample']}, {'label': 'Patient with Covid-19 confirmed (severe form)', 'description': 'Covid-19 confirmed : severe form', 'interventionNames': ['Other: blood sample']}, {'label': 'Patient with Covid-19 not confirmed', 'description': 'Covid-19 not confirmed', 'interventionNames': ['Other: blood sample']}], 'interventions': [{'name': 'blood sample', 'type': 'OTHER', 'description': 'Collection', 'armGroupLabels': ['Patient with Covid-19 confirmed (middle form)', 'Patient with Covid-19 confirmed (severe form)', 'Patient with Covid-19 not confirmed']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34280', 'city': 'Montpellier', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Edouard TUAILLON, MD; PhD', 'role': 'CONTACT', 'email': 'e-tuaillon@chu-montpellier.fr', 'phone': '467 338 469', 'phoneExt': '33'}], 'facility': 'Uh Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'centralContacts': [{'name': 'Edouard TUAILLON, MD; PhD', 'role': 'CONTACT', 'email': 'e-tuaillon@chu-montpellier.fr', 'phone': '467 338 469', 'phoneExt': '33'}], 'overallOfficials': [{'name': 'Edouard TUAILLON, MD; PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'UH MONTPELLIER'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'NC'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}