Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-27 @ 11:32 AM
Study NCT ID:
NCT04492267
Status:
UNKNOWN
Last Update Posted:
2020-07-30
First Post:
2020-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Inflammatory Bowel Disease (IBD) and Covid-19 Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003424', 'term': 'Crohn Disease'}, {'id': 'D003093', 'term': 'Colitis, Ulcerative'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D003643', 'term': 'Death'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D003092', 'term': 'Colitis'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 700}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-07-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2021-01-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-29', 'studyFirstSubmitDate': '2020-07-23', 'studyFirstSubmitQcDate': '2020-07-29', 'lastUpdatePostDateStruct': {'date': '2020-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Retrospective analysis of severity and specific needs in case of SARS-CoV-2 infection in IBD patients', 'timeFrame': 'Files analysed retrospectily from March 1st, 2020 to July 31, 2020 will be examined'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['SARS-CoV-2', 'Inflammatory Bowel Disease', 'IBD', "Crohn's disease", 'Ulcerative colitis', 'Immunosuppressant therapy', 'Biologicals', 'Severe respiratory disease', 'intensive care unit', 'Mechanical ventilation', 'Death'], 'conditions': ['Inflammatory Bowel Disease']}, 'descriptionModule': {'briefSummary': "Most of the inflammatory bowel disease (IBD: Crohn's disease and ulcerative colitis) in a tertiary expert Centre are on immunosuppressive and/or biological therapy. Theoretically, these treatments may increase patients' risk of infection, in particular viral infection. Therefore, the current SARS-Cov-2 pandemia, with its unprecedent worldwide morbidity and mortality, may have a negative impact on IBD patients' clinical course. Identifying an increased risk in this particular patients' population as well as the risk/protective factors is of outstanding importance, in order to adapt their treatment and surveillance. As a consequence, our aims were (i) to measure retrospectively the risk of SARS-CoV-2 (proven by biological testing or suspected due to record of potential clinical symptoms of COVID-19 infection) in this patients' cohort (principal objective), (ii) to identify risk or protective factors for SARS-CoV-2 infection in IBD, and (iii) to analyze the outcome of patients in case of suspected or confirmed COVID-19. The results of this study may be important to adjust our surveillance and therapeutic strategy in these patients, in particular if high virus circulation will occur in the future."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "IBD patient (Crohn's disease, ulcerative colitis, indeterminate colitis) over the age of 18 years", 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient over the age of 18 years\n* IBD patients (Crohn's disease, ulcerative colitis, indeterminate colitis)\n* Patient agreeing to participate in the study\n\nExclusion Criteria:\n\n* Patient unable to understand the study protocol or to answer simple anamnestic questions due to language barrier\n* Patient under guardianship or trusteeship\n* Patient under safeguard of justice"}, 'identificationModule': {'nctId': 'NCT04492267', 'acronym': 'MICI-Covid-19', 'briefTitle': 'Inflammatory Bowel Disease (IBD) and Covid-19 Infection', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'SARS-CoV-2 Infection in Patients From Two Tertiary Inflammatory Bowel Disease (IBD) Centres: Frequency of Suspected and Confirmed Infections, Severity and Outcome Management', 'orgStudyIdInfo': {'id': '7930'}}, 'contactsLocationsModule': {'locations': [{'zip': '67091', 'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jean-Marie REIMUND, MD, PhD', 'role': 'CONTACT', 'email': 'jean-marie.reimund@chru-strasbourg.fr', 'phone': '33 3 88 12 74 41'}, {'name': 'Jean-Marie REIMUND, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Bénédicte CARON, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Yves ARONDEL, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Service Hépato-Gastroentérologie et Assistance Nutritive Hôpitaux Univesitaires de Strasbourg', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'centralContacts': [{'name': 'Jean-Marie REIMUND, MD, PhD', 'role': 'CONTACT', 'email': 'jean-marie.reimund@chru-strasbourg.fr', 'phone': '33 3 88 12 74 41'}, {'name': 'Saïd CHAYER, PhD, HDR', 'role': 'CONTACT', 'email': 'said.chayer@chru-strasbourg.fr', 'phone': '33 3 88 11 66 90'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}