Ignite Creation Date:
2025-12-24 @ 1:29 PM
Ignite Modification Date:
2026-01-02 @ 10:07 AM
Study NCT ID:
NCT05803395
Status:
UNKNOWN
Last Update Posted:
2023-11-28
First Post:
2023-04-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Incidence of Severe COVID-19 Infection in Patients With CLL or B-NHL Who Received Pre-exposure Prophylaxis With Tixagevimab and Cilgavimab in Italy.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015451', 'term': 'Leukemia, Lymphocytic, Chronic, B-Cell'}, {'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D015448', 'term': 'Leukemia, B-Cell'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 954}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-22', 'studyFirstSubmitDate': '2023-04-06', 'studyFirstSubmitQcDate': '2023-04-06', 'lastUpdatePostDateStruct': {'date': '2023-11-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assess the percentage of patients who develop severe COVID-19 infection', 'timeFrame': 'at 12 months', 'description': 'Evaluation of prophylaxis efficacy in terms of percentage of patients with CLL or indolent B-NHL who develop severe COVID-19 infection, defined as COVID-19-related hospitalization or COVID -19 related death'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Lymphocytic Leukemia', 'Indolent B-Cell Non-Hodgkin Lymphoma', 'COVID-19']}, 'descriptionModule': {'briefSummary': 'This is an observational retrospective and prospective multicenter study aimed at describing the role of the COVID -19 prophylaxis with Tixagevimab and Cilgavimab in CLL or indolent B-NHL patients who received first COVID-19 prophylaxis dose between March 2022 and October 2022.', 'detailedDescription': 'This is an observational retrospective and prospective multicenter study aimed at describing the role of the COVID -19 prophylaxis with Tixagevimab and Cilgavimab in CLL or indolent B-NHL patients.\n\nAll CLL or indolent B-cell NHL patients (follicular lymphoma, marginal zone lymphoma, lymphoplasmacytic lymphoma) who received first COVID-19 prophylaxis dose with Tixagevimab and Cilgavimab according to AIFA indication between March 2022 and October 2022 will be included in the study.\n\nEach patient will be followed for a maximum of 12 months from the first COVID-19 prophylaxis dose.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with CLL or indolent B-NHL (follicular lymphoma, marginal zone lymphoma, lymphoplasmacytic lymphoma) who received the Tixagevimab and Cilgavimab as per Agenzia Italiana del Farmaco (AIFA) indications.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Patient with CLL or indolent B-NHL who received the first COVID-19 prophylaxis dose with Tixagevimab and Cilgavimab as per label indication between March 2022 and October 2022.\n3. Signed informed consent, if applicable\n\nExclusion Criteria:\n\nNone'}, 'identificationModule': {'nctId': 'NCT05803395', 'briefTitle': 'Incidence of Severe COVID-19 Infection in Patients With CLL or B-NHL Who Received Pre-exposure Prophylaxis With Tixagevimab and Cilgavimab in Italy.', 'organization': {'class': 'OTHER', 'fullName': "Gruppo Italiano Malattie EMatologiche dell'Adulto"}, 'officialTitle': 'Incidence of Severe COVID-19 Infection in Patients With Chronic Lymphocytic Leukemia or Indolent B-cell Non-Hodgkin Lymphoma Who Received Pre-exposure Prophylaxis With Tixagevimab and Cilgavimab in Italy: an Observational Study by the GIMEMA Working Party on Chronic Lymphoproliferative Disorders and by the Fondazione Italiana Linfomi', 'orgStudyIdInfo': {'id': 'CLL2423'}}, 'contactsLocationsModule': {'locations': [{'city': 'Cosenza', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Massimo Gentile', 'role': 'CONTACT'}], 'facility': 'UOC Ematologia AO Cosenza', 'geoPoint': {'lat': 39.2989, 'lon': 16.25307}}, {'city': 'Ferrara', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Antonio Cuneo', 'role': 'CONTACT'}], 'facility': 'Ematologia AOU S.Anna', 'geoPoint': {'lat': 44.83804, 'lon': 11.62057}}, {'city': 'Florence', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Alessandro Sanna', 'role': 'CONTACT'}], 'facility': 'Ematologia AOU Careggi', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'city': 'Lecco', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Clara V Viganò', 'role': 'CONTACT'}], 'facility': 'ASST Lecco Ospedale A.Manzoni', 'geoPoint': {'lat': 45.85589, 'lon': 9.39704}}, {'city': 'Livorno', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Rossella Riccioni', 'role': 'CONTACT'}], 'facility': 'UOC Ematologia ATMO', 'geoPoint': {'lat': 43.54427, 'lon': 10.32615}}, {'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Anna Maria Frustaci', 'role': 'CONTACT'}], 'facility': 'ASST Grande Ospedale Metropolitano Niguarda', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'Novara', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Riccardo Moia', 'role': 'CONTACT'}], 'facility': 'SCDU Ematologia', 'geoPoint': {'lat': 45.44694, 'lon': 8.62118}}, {'city': 'Palermo', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Maurizio Musso', 'role': 'CONTACT'}], 'facility': 'Dipartimento Oncologico La Maddalena', 'geoPoint': {'lat': 38.1166, 'lon': 13.3636}}, {'city': 'Palermo', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Caterina Patti', 'role': 'CONTACT'}], 'facility': 'UOC DI ONCOEMATOLOGIA AOR Villa Sofia - Cervello', 'geoPoint': {'lat': 38.1166, 'lon': 13.3636}}, {'city': 'Roma', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Francesca R Mauro', 'role': 'CONTACT'}], 'facility': 'Ematologia Università "Sapienza" Roma', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'Rozzano', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Armando Santoro', 'role': 'CONTACT'}], 'facility': 'IRCCS Istituto Clinico Humanitas', 'geoPoint': {'lat': 45.38193, 'lon': 9.1559}}, {'city': 'San Giovanni Rotondo', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Angelo Carella', 'role': 'CONTACT'}], 'facility': 'UOC Ematologia Casa Sollievo della Sofferenza', 'geoPoint': {'lat': 41.70643, 'lon': 15.7277}}, {'city': 'Torino', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Daniela Gottardi', 'role': 'CONTACT'}], 'facility': 'SCDU Ematologia e terapie cellulari AO Mauriziano', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}, {'city': 'Trento', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Anna Guella', 'role': 'CONTACT'}], 'facility': 'Ematologia Ospedale S.Chiara', 'geoPoint': {'lat': 46.06787, 'lon': 11.12108}}, {'city': 'Treviso', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Filippo Gherlinzoni', 'role': 'CONTACT'}], 'facility': 'UOC ematologia ULSS2 Marca Trevigiana', 'geoPoint': {'lat': 45.66673, 'lon': 12.2416}}], 'centralContacts': [{'name': 'Paola Fazi', 'role': 'CONTACT', 'email': 'p.fazi@gimema.it', 'phone': '0670390528'}, {'name': 'Enrico Crea', 'role': 'CONTACT', 'email': 'e.crea@gimema.it', 'phone': '0670390514'}], 'overallOfficials': [{'name': 'Gian Matteo Rigolin', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ematologia - Azienda Ospedaliero Universitaria S.Anna di Ferrara'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Gruppo Italiano Malattie EMatologiche dell'Adulto", 'class': 'OTHER'}, 'collaborators': [{'name': 'Fondazione Italiana Linfomi', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}