Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-27 @ 7:16 AM
Study NCT ID:
NCT04932967
Status:
COMPLETED
Last Update Posted:
2022-06-22
First Post:
2021-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of nMoABs for the Treatment of COVID-19 in Patients With HM.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D019337', 'term': 'Hematologic Neoplasms'}], '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'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 91}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2022-04-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-21', 'studyFirstSubmitDate': '2021-06-17', 'studyFirstSubmitQcDate': '2021-06-17', 'lastUpdatePostDateStruct': {'date': '2022-06-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'time to SARS-nCov-2 test negativization', 'timeFrame': '3 months', 'description': 'To assess the efficacy of nMoAbs in infected HM patients compared to the historical control'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Neutralizing Monoclonal Antibodies'], 'conditions': ['Covid19', 'Hematological Malignancy']}, 'referencesModule': {'references': [{'pmid': '35906881', 'type': 'DERIVED', 'citation': 'Marasco V, Piciocchi A, Candoni A, Pagano L, Guidetti A, Musto P, Bruna R, Bocchia M, Visentin A, Turrini M, Tucci A, Pilerci S, Fianchi L, Salvini M, Galimberti S, Coviello E, Selleri C, Luppi M, Crea E, Fazi P, Passamonti F, Corradini P. Neutralizing monoclonal antibodies in haematological patients paucisymptomatic for COVID-19: The GIMEMA EMATO-0321 study. Br J Haematol. 2022 Oct;199(1):54-60. doi: 10.1111/bjh.18385. Epub 2022 Jul 30.'}]}, 'descriptionModule': {'briefSummary': 'This is a multicenter retrospective, non-interventional observational study to evaluate the efficacy of nMoAbs in HM patients.', 'detailedDescription': 'This is a multicenter retrospective, non-interventional observational study. The participating centres will retrospectively review all episodes of SARS-CoV-2 infection occurring in HMs identified at their institutions from February 2020 to May 2021 and treated with nMoAbs, to evaluate their efficacy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will include patients older than 18 years of age with HM who received nMoAbs, approved by AIFA, for the treatment of SARS-CoV-2 infection.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients must meet all the following criteria for study entry:\n\n 1. Age equal to or greater than 18 years of age.\n 2. Diagnosis of HM (acute leukemias, myelodysplastic syndromes, myeloproliferative neoplasms, lymphomas, myeloma, chronic myeloprolipherative disorders) at any stage/status.\n 3. Third generation rapid molecular or antigen test positive for SARS-CoV-2 from February 2020 until May 2021\n 4. Treatment with anti SARS CoV 2 nMoAbs approved by AIFA\n 5. Not hospitalized for COVID-19 at the time of nMoAbs administration\n 6. Not on oxygen therapy at the time of nMoAbs administration\n 7. At least one of the following symptoms for no more than 10 days:\n\n * Fever\n * Cough\n * Anosmia\n * Ageusia / dysgeusia\n * Pharyngodynia\n * Asthenia\n * Headache\n * Nausea\n * Diarrhea\n * Myalgia\n * Dyspnea\n * Tachypnea\n 8. Signed written informed consent according to ICH/EU/GCP and national local laws (if applicable).\n\nExclusion Criteria:\n\n* 1\\. Hematological diseases, other than HM.\n\n 2\\. Not tested positive for SARS-CoV-2\n\n 3\\. Patients in disease remission "off therapy" for more than 6 months\n\n 4\\. Immune plasma treatment in the previous two months'}, 'identificationModule': {'nctId': 'NCT04932967', 'briefTitle': 'Use of nMoABs for the Treatment of COVID-19 in Patients With HM.', 'organization': {'class': 'OTHER', 'fullName': "Gruppo Italiano Malattie EMatologiche dell'Adulto"}, 'officialTitle': 'Use of Neutralizing Monoclonal Antibodies for the Treatment of COVID-19 in Patients With Hematological Malignancies (SIE-GIMEMA Study)', 'orgStudyIdInfo': {'id': 'EMATO0321'}}, 'contactsLocationsModule': {'locations': [{'city': 'Bari', 'country': 'Italy', 'facility': 'Aou Consorziale Policlinico - Uo Ematologia Con Trapianto', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}, {'city': 'Brescia', 'country': 'Italy', 'facility': 'Asst Degli Spedali Civili Di Brescia', 'geoPoint': {'lat': 45.53558, 'lon': 10.21472}}, {'city': 'Como', 'country': 'Italy', 'facility': 'Ospedale Valduce - Uos Ematologia', 'geoPoint': {'lat': 45.80819, 'lon': 9.0832}}, {'city': 'Florence', 'country': 'Italy', 'facility': 'Aou Careggi', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'city': 'Genova', 'country': 'Italy', 'facility': 'Irccs Aou San Martino', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}, {'city': 'Milan', 'country': 'Italy', 'facility': 'Fondazione Irccs "Istituto Nazionale Tumori"', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'Novara', 'country': 'Italy', 'facility': 'Aou Maggiore Della Carità Di Novara', 'geoPoint': {'lat': 45.44694, 'lon': 8.62118}}, {'city': 'Padua', 'country': 'Italy', 'facility': 'AOU Padova', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}, {'city': 'Pisa', 'country': 'Italy', 'facility': 'Aou Pisana - Uo Ematologia Universitaria', 'geoPoint': {'lat': 43.70853, 'lon': 10.4036}}, {'city': 'Roma', 'country': 'Italy', 'facility': 'Fondazione Policlinico Universitario Agostino Gemelli-Irccs', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'Salerno', 'country': 'Italy', 'facility': 'Aou "San Giovanni Di Dio E Ruggi D\'Aragona" - Salerno - Uoc Ematologia E Trapianti Di Cellule Staminali Emopoietiche', 'geoPoint': {'lat': 40.67545, 'lon': 14.79328}}, {'city': 'Siena', 'country': 'Italy', 'facility': 'Aou Senese', 'geoPoint': {'lat': 43.31822, 'lon': 11.33064}}, {'city': 'Udine', 'country': 'Italy', 'facility': 'Asui Di Udine, Presidio Ou "S. Maria Della Misericordia"', 'geoPoint': {'lat': 46.0693, 'lon': 13.23715}}, {'city': 'Varese', 'country': 'Italy', 'facility': 'Asst Dei Sette Laghi, Ospedale Di Circolo E Fondazione Macchi', 'geoPoint': {'lat': 45.82058, 'lon': 8.82511}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Gruppo Italiano Malattie EMatologiche dell'Adulto", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}