Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2026-02-20 @ 6:46 PM
Study NCT ID:
NCT04465656
Status:
UNKNOWN
Last Update Posted:
2020-10-06
First Post:
2020-06-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Registry of the Evolution of Diagnosed and/or Hospitalized Patients for Pulmonary Embolism During the Covid-19 Pandemic
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011655', 'term': 'Pulmonary Embolism'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D004617', 'term': 'Embolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012698', 'term': 'Serologic Tests'}], 'ancestors': [{'id': 'D007159', 'term': 'Immunologic Tests'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-07-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2021-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-10-05', 'studyFirstSubmitDate': '2020-06-30', 'studyFirstSubmitQcDate': '2020-07-09', 'lastUpdatePostDateStruct': {'date': '2020-10-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '% of patients for each group presenting the occurrence of PE complications defined by the occurrence of at least ONE of the following events up to 6 months after PE diagnosis.', 'timeFrame': '6 months after PE diagnosis', 'description': 'PE complications :\n\n* Chronic interstitial pathology, or\n* Recurrence of PE, or\n* Pulmonary hypertension, or\n* Death.'}], 'secondaryOutcomes': [{'measure': '% of patients for each group and subgroup presenting the occurrence of PE complications defined by the occurrence of at least ONE of the following events up to 12 months after PE diagnosis.', 'timeFrame': '12 months after PE diagnosis', 'description': 'PE complications :\n\n* Chronic interstitial pathology, or\n* Recurrence of PE, or\n* Pulmonary hypertension, or\n* Death.'}, {'measure': '% of patients in each group presenting the occurrence of each of the following events at each follow-up (3 months, 6 months and 12 months after PE diagnosis).', 'timeFrame': '3, 6 and 12 months after PE diagnosis', 'description': 'PE complications :\n\n* Chronic interstitial pathology, or\n* Recurrence of PE, or\n* Pulmonary hypertension, or\n* Death.'}, {'measure': '% of patients diagnosed COVID - at M0 by RT-PCR on nasopharyngeal swab and diagnosed COVID + by serology 3 months after PE diagnosis', 'timeFrame': '3 months after PE diagnosis'}, {'measure': 'Effectiveness of the different category of treatments used in all patients and in the groups: % of occurrence of PE complications for each categories of treatments', 'timeFrame': '12 months after PE diagnosis', 'description': 'Category of treatments:\n\n* Heparin + AVK\n* Heparin + DOAC\n\nPE complication :\n\n* Chronic interstitial pathology, or\n* Recurrence of PE, or\n* Pulmonary hypertension, or\n* Death.'}, {'measure': 'Effectiveness of the different category of treatments used in all patients and in the groups: % of patients with occurrence of bleeding complications for each categories of treatments', 'timeFrame': '12 months after PE diagnosis', 'description': 'Category of treatments:\n\n* Heparin + AVK\n* Heparin + DOAC\n\nBleeding complications: classification 1-2-3-5 according to BARC'}, {'measure': 'Effectiveness of the different category of treatments used in all patients and in the groups: % of patients with no occurrence of complications for each categories of treatments', 'timeFrame': '12 months after PE diagnosis', 'description': 'Category of treatments:\n\n* Heparin + AVK\n* Heparin + DOAC'}, {'measure': 'Effectiveness of the different category of treatments used in all patients and in the groups: duration of Heparin treatment (number of day)', 'timeFrame': '12 months after PE diagnosis', 'description': 'Category of treatments:\n\n* Heparin + AVK\n* Heparin + DOAC'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pulmonary Embolism']}, 'descriptionModule': {'briefSummary': 'The purpose of the study COVID-EP is to classify all the complications occurring after the diagnosis of pulmonary embolism in patients tested initially COVID-19 positive and negative by RT-PCR (on nasopharyngeal sample) during the peak of the pandemic in France (April 2020). The patients will be followed for 1 year in order to provide clinical and paraclinical data not yet published in the literature. In order to secondarily confirm the COVID-19 status of initially negative COVID-19 patients (by RT-PCR), a serology test will be performed. The collected complications will then be compared between each of the 3 following groups: \\[PCR-COVID 19-Neg \\& Sero-COVID 19-Neg\\] versus \\[PCR-COVID 19-Neg \\& Sero-COVID 19-Pos\\] versus \\[PCR-COVID 19-Pos\\].'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient diagnosed and / or hospitalized for PE in April 2020 (the COVID-19 pandemic peak)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged ≥ 18 years,\n* Diagnosed for pulmonary embolism between April 1st and April 30th, 2020; (treated by ambulatory care or hospitalized),\n* Having given free and informed written consent,\n* Being affiliated with or benefiting from a social security scheme.\n\nExclusion Criteria:\n\n* Subject to a measure for the protection of justice.'}, 'identificationModule': {'nctId': 'NCT04465656', 'acronym': 'COVID-EP', 'briefTitle': 'Registry of the Evolution of Diagnosed and/or Hospitalized Patients for Pulmonary Embolism During the Covid-19 Pandemic', 'organization': {'class': 'OTHER', 'fullName': 'Hospital St. Joseph, Marseille, France'}, 'officialTitle': 'Registry of the Evolution of Diagnosed and/or Hospitalized Patients for Pulmonary Embolism During the Covid-19 Pandemic: Retrospective and Prospective Multicentric Study.', 'orgStudyIdInfo': {'id': '2020-05-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': '[PCR-COVID 19-Pos] group', 'description': 'Having a microbiological diagnosis confirming COVID-19 infection (ie positive RT-PCR on nasopharyngeal swab) and/or clinical/CT signs'}, {'label': '[PCR-COVID 19-Neg] group', 'description': 'Having a microbiological diagnosis confirming the absence of COVID-19 infection (ie negative RT-PCR on nasopharyngeal swab) and absence of clinical /CT signs', 'interventionNames': ['Diagnostic Test: Serology test for COVID-19']}, {'label': '[PCR-COVID 19-Neg & Sero-COVID 19-Pos] group', 'description': '* Having a microbiological diagnosis confirming the absence of COVID-19 infection (ie negative RT-PCR on nasopharyngeal swab) and absence of clinical /CT signs\n* Having been tested positive in a serological test for COVID-19 at M3'}, {'label': '[PCR-COVID 19-Neg & Sero-COVID 19-Neg] group', 'description': '* Having a microbiological diagnosis confirming the absence of COVID-19 infection (ie negative RT-PCR on nasopharyngeal swab) and absence of clinical /CT signs\n* Having been tested negative in a serological test for COVID-19 at M3'}], 'interventions': [{'name': 'Serology test for COVID-19', 'type': 'DIAGNOSTIC_TEST', 'description': 'In order to secondarily confirm the COVID-19 status of initially negative COVID-19 patients (by RT-PCR), a serology test will be performed in two parts:\n\n1. ELISA test\n2. Rapid Diagnostic tests (only if ELISA test is positive)', 'armGroupLabels': ['[PCR-COVID 19-Neg] group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Marseille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Roger Rosario, Dr', 'role': 'CONTACT'}], 'facility': 'Hôpital Saint Joseph Marseille', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}], 'centralContacts': [{'name': 'Cécile Bielmann', 'role': 'CONTACT', 'email': 'cbielmann@hopital-saint-joseph.fr', 'phone': '0033 (0)4 88 73 10 70'}, {'name': 'Rahmia AHAMADA', 'role': 'CONTACT', 'email': 'rahamada@hopital-saint-joseph.fr', 'phone': '0033 (0)4 91 80 71 12'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital St. Joseph, Marseille, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}