Ignite Creation Date:
2025-12-24 @ 3:43 PM
Ignite Modification Date:
2025-12-26 @ 8:19 AM
Study NCT ID:
NCT04317092
Status:
UNKNOWN
Last Update Posted:
2023-03-24
First Post:
2020-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tocilizumab in COVID-19 Pneumonia (TOCIVID-19)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D011014', 'term': 'Pneumonia'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'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': 'C502936', 'term': 'tocilizumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This is a multicenter, single-arm, open-label, phase 2 study. All the patients enrolled are treated with tocilizumab'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 402}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-03-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-12-19', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-23', 'studyFirstSubmitDate': '2020-03-19', 'studyFirstSubmitQcDate': '2020-03-19', 'lastUpdatePostDateStruct': {'date': '2023-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lethality rate two weeks after registration', 'timeFrame': 'up to 15 days', 'description': '2-week lethality is defined as the ratio of the number of subjects dead within 14 days from study start out of phase 2 patients with baseline information.'}, {'measure': 'Lethality rate one month after registration', 'timeFrame': 'up to 1 month', 'description': '1-month lethality is defined as the ratio of the number of subjects dead within 30 days from study start out of phase 2 patients with baseline information.'}], 'secondaryOutcomes': [{'measure': 'Interleukin-6 level', 'timeFrame': 'baseline, during treatment (cycle 1 and 2 every 12 hours) up to 1 month', 'description': 'IL-6 levels will be assessed using commercial ELISA method.'}, {'measure': 'Lymphocyte count', 'timeFrame': 'baseline, during treatment (cycle 1 and 2 every 12 hours) up to 1 month', 'description': 'Lymphocyte count assessed by routinely used determination of blood count'}, {'measure': 'CRP (C-reactive protein) level', 'timeFrame': 'baseline, during treatment (cycle 1 and 2 every 12 hours) up to 1 month', 'description': 'CRP is assessed by routinely used determination of CRP'}, {'measure': 'PaO2 (partial pressure of oxygen) / FiO2 (fraction of inspired oxygen, FiO2) ratio (or P/F ratio)', 'timeFrame': 'baseline, during treatment (cycle 1 and 2 every 12 hours) up to 1 month', 'description': 'calculated from arterial blood gas analyses (values from 300 to 100)'}, {'measure': 'Change of the SOFA (Sequential Organ Failure Assessment)', 'timeFrame': 'baseline, during treatment (cycle 1 and 2 every 12 hours) up to 1 month', 'description': 'It evaluates 6 variables, each representing an organ system (one for the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems), and scored from 0 (normal) to 4 (high degree of dysfunction/failure). Thus, the maximum score may range from 0 to 24.'}, {'measure': 'Number of participants with treatment-related side effects as assessed by Common Terminology Criteria for Adverse Event (CTCAE) version 5.0', 'timeFrame': 'during treatment and up to 30 days after the last treatment dose', 'description': 'graded according to CTCAE citeria (v5.0)'}, {'measure': 'Radiological response', 'timeFrame': 'at baseline (optional), after seven days and if clinically indicated (up to 1 month)', 'description': 'Thoracic CT scan or Chest XR'}, {'measure': 'Duration of hospitalization', 'timeFrame': "from baseline up to patient's discharge (up to 1 month)", 'description': 'Days of hospitalization'}, {'measure': 'Remission of respiratory symptoms', 'timeFrame': 'up to 1 month', 'description': 'time to invasive mechanical ventilation (if not previously initiated) calculated from baseline to intubation'}, {'measure': 'Remission of respiratory symptoms', 'timeFrame': 'up to 1 month', 'description': 'time to definitive extubation calculated from intubation (any time occurred) to extubation in days'}, {'measure': 'Remission of respiratory symptoms', 'timeFrame': 'up to 1 month', 'description': 'time to independence from non-invasive mechanical ventilation calculated in days'}, {'measure': 'Remission of respiratory symptoms', 'timeFrame': 'up to 1 month', 'description': 'time to independence from oxygen therapy in days'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19', 'pneumonia', 'tocilizumab', 'Interleukin-6'], 'conditions': ['COVID-19 Pneumonia']}, 'referencesModule': {'references': [{'pmid': '33087150', 'type': 'DERIVED', 'citation': 'Perrone F, Piccirillo MC, Ascierto PA, Salvarani C, Parrella R, Marata AM, Popoli P, Ferraris L, Marrocco-Trischitta MM, Ripamonti D, Binda F, Bonfanti P, Squillace N, Castelli F, Muiesan ML, Lichtner M, Calzetti C, Salerno ND, Atripaldi L, Cascella M, Costantini M, Dolci G, Facciolongo NC, Fraganza F, Massari M, Montesarchio V, Mussini C, Negri EA, Botti G, Cardone C, Gargiulo P, Gravina A, Schettino C, Arenare L, Chiodini P, Gallo C; TOCIVID-19 investigators, Italy. Tocilizumab for patients with COVID-19 pneumonia. The single-arm TOCIVID-19 prospective trial. J Transl Med. 2020 Oct 21;18(1):405. doi: 10.1186/s12967-020-02573-9.'}, {'pmid': '33043164', 'type': 'DERIVED', 'citation': 'Chiodini P, Arenare L, Piccirillo MC, Perrone F, Gallo C. A phase 2, open label, multicenter, single arm study of tocilizumab on the efficacy and tolerability of tocilizumab in the treatment of patients with COVID-19 pneumonia (TOCIVID-19 trial): Statistical analysis plan. Contemp Clin Trials Commun. 2020 Dec;20:100665. doi: 10.1016/j.conctc.2020.100665. Epub 2020 Oct 7.'}, {'pmid': '33031955', 'type': 'DERIVED', 'citation': 'Piccirillo MC, Ascierto P, Atripaldi L, Cascella M, Costantini M, Dolci G, Facciolongo N, Fraganza F, Marata A, Massari M, Montesarchio V, Mussini C, Negri EA, Parrella R, Popoli P, Botti G, Arenare L, Chiodini P, Gallo C, Salvarani C, Perrone F. TOCIVID-19 - A multicenter study on the efficacy and tolerability of tocilizumab in the treatment of patients with COVID-19 pneumonia. Study protocol. Contemp Clin Trials. 2020 Nov;98:106165. doi: 10.1016/j.cct.2020.106165. Epub 2020 Oct 6.'}]}, 'descriptionModule': {'briefSummary': 'This study project includes a single-arm phase 2 study and a parallel cohort study, enrolling patients with COVID-19 pneumonia.', 'detailedDescription': 'Phase 2 study: this is a multicenter, single-arm, open-label, phase 2 study. All the patients enrolled are treated with tocilizumab. Two-week (14 days) and one-month (30 days) lethality rates are the co-primary endpoints.\n\nThe parallel cohort includes patients who are treated with tocilizumab and cannot enter the phase 2 study because:\n\n1. emergency conditions or infrastructural or operational limits prevented registration before the administration of the experimental drug or\n2. they had been intubated more than 24 hours before registration or\n3. the phase 2 study has been closed due to reached sample size.\n\nThis means that, after closure of the phase 2 enrolment, patients who might be eligible for the phase 2 study will be included in the observational cohort study.\n\nThe same information planned for the phase 2 cohort is required also for the parallel cohort study whose sample size is not defined a priori, and that will close at the end of the overall project. All the patients enrolled are treated with tocilizumab.\n\nIn both study groups (phase 2 and parallel cohort), participants receive one dose of Tocilizumab 8 mg/kg (up to a maximum of 800mg per dose). A second administration (same dose) can be given after 12 hours if respiratory function has not recovered, at discretion of the Investigator.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Any gender\n2. No age limit\n3. Informed consent for participation in the study (consent can be oral if a written consent cannot be expressed. If the subject is incapable of giving an informed consent and an authorized representative is not available without a delay that would, in the opinion of the Investigator, compromise the potential life-saving effect of the treatment this can be administered without consent. Consent to remain in the research should be sought as soon the conditions of the patient will allow it)\n4. Virological diagnosis of SARS-CoV-2 infection (real-time PCR)\n5. Hospitalized due to clinical/instrumental diagnosis of pneumonia\n6. Oxygen saturation at rest in ambient air ≤93% or requiring oxygen therapy or mechanical ventilation either non invasive or invasive (intubated)\n7. Patients with criteria #4 and #5 who have been already treated with tocilizumab before registration are eligible for the observational retrospective cohort\n\nExclusion Criteria:\n\n1. Known hypersensitivity to tocilizumab or its excipients\n2. Known active infections or other clinical condition that contraindicate tocilizumab and cannot be treated or solved according to the judgement of the clinician\n3. ALT / AST\\> 5 times the upper limit of the normality\n4. Neutrophils \\<500 / mmc\n5. Platelets \\<50.000 / mmc\n6. Bowel diverticulitis or perforation'}, 'identificationModule': {'nctId': 'NCT04317092', 'acronym': 'TOCIVID-19', 'briefTitle': 'Tocilizumab in COVID-19 Pneumonia (TOCIVID-19)', 'organization': {'class': 'OTHER', 'fullName': 'National Cancer Institute, Naples'}, 'officialTitle': 'Multicenter Study on the Efficacy and Tolerability of Tocilizumab in the Treatment of Patients With COVID-19 Pneumonia', 'orgStudyIdInfo': {'id': 'TOCIVID-19'}, 'secondaryIdInfos': [{'id': '2020-001110-38', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'tocilizumab treatment', 'description': 'All the patients enrolled are treated with tocilizumab.', 'interventionNames': ['Drug: Tocilizumab Injection']}], 'interventions': [{'name': 'Tocilizumab Injection', 'type': 'DRUG', 'description': 'Tocilizumab 8 mg/kg (up to a maximum of 800mg per dose). A second administration (same dose) can be given after 12 hours if respiratory function has not recovered, at discretion of the Investigator.', 'armGroupLabels': ['tocilizumab treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alessandria', 'country': 'Italy', 'facility': 'Azienda Ospedaliera "SS. Antonio e Biagio e C. Arrigo" (Dipartimento Internistico SSD Reumatologia)', 'geoPoint': {'lat': 44.90924, 'lon': 8.61007}}, {'city': 'Busto Arsizio', 'country': 'Italy', 'facility': 'Ospedale di Busto Arsizio ASST Valle Olona (U.O.C. Malattie Infettive)', 'geoPoint': {'lat': 45.61128, 'lon': 8.84914}}, {'city': 'Catania', 'country': 'Italy', 'facility': "A.O.U. Policlinico V. Emanuele (U.O. di Malattie infettive, U.O. di Anestesia e Rianimazione, U.O. di Medicina d'Urgenza)", 'geoPoint': {'lat': 37.49223, 'lon': 15.07041}}, {'city': 'Catania', 'country': 'Italy', 'facility': 'AOE Cannizzaro di Catania (U.O. di Malattie Infettive, U.O. di Anestesia e Rianimazione, U.O.', 'geoPoint': {'lat': 37.49223, 'lon': 15.07041}}, {'city': 'Cosenza', 'country': 'Italy', 'facility': 'Ospedale Annunziata Azienda Ospedaliera di Cosenza (U.O.C. Malattie Infettive)', 'geoPoint': {'lat': 39.2989, 'lon': 16.25307}}, {'city': 'Magenta', 'country': 'Italy', 'facility': 'ASST OVEST MILANESE presidi Legnano - Magenta', 'geoPoint': {'lat': 45.46456, 'lon': 8.88453}}, {'zip': '42100', 'city': 'Modena', 'country': 'Italy', 'facility': 'Azienda Ospedaliero-Universitaria di Modena', 'geoPoint': {'lat': 44.64783, 'lon': 10.92539}}, {'city': 'Modena', 'country': 'Italy', 'facility': 'A.O.U. di Modena (Dipartimento Chirurgie Generali e Specialità Chirurgiche - Struttura Complessa di Anestesia e Rianimazione I)', 'geoPoint': {'lat': 44.64783, 'lon': 10.92539}}, {'city': 'Modena', 'country': 'Italy', 'facility': 'A.O.U. di Modena (Dipartimento Chirurgie Generali e Specialità Chirurgiche - Struttura Complessa di Anestesia e Rianimazione II)', 'geoPoint': {'lat': 44.64783, 'lon': 10.92539}}, {'city': 'Modena', 'country': 'Italy', 'facility': 'A.O.U. di Modena (Dipartimento Medicine Specialistiche - Struttura Complessa Malattie Infettive)', 'geoPoint': {'lat': 44.64783, 'lon': 10.92539}}, {'city': 'Modena', 'country': 'Italy', 'facility': "Dipartimento Medicine Specialistiche - Struttura Complessa Malattie dell'Apparato Respiratorio", 'geoPoint': {'lat': 44.64783, 'lon': 10.92539}}, {'zip': '80131', 'city': 'Naples', 'country': 'Italy', 'facility': 'A.O.R.N. Ospedale dei Colli Monaldi-Cotugno-CTO (U.O.C. Oncologia)', 'geoPoint': {'lat': 40.85216, 'lon': 14.26811}}, {'zip': '80131', 'city': 'Naples', 'country': 'Italy', 'facility': 'National Cancer Institute', 'geoPoint': {'lat': 40.85216, 'lon': 14.26811}}, {'city': 'Naples', 'country': 'Italy', 'facility': 'A.O.R.N. Ospedale dei Colli Monaldi-Cotugno-CTO (U.O.C. Anestesia Rianimazione e terapia intensiva)', 'geoPoint': {'lat': 40.85216, 'lon': 14.26811}}, {'city': 'Naples', 'country': 'Italy', 'facility': 'A.O.R.N. Ospedale dei Colli Monaldi-Cotugno-CTO (U.O.C. Malattie Infettive ad indirizzo respiratorio)', 'geoPoint': {'lat': 40.85216, 'lon': 14.26811}}, {'city': 'Pesaro', 'country': 'Italy', 'facility': "A.O. Ospedali Riuniti Marche Nord - Presidio Ospedaliero San Salvatore di Pesaro (UOC Pronto Soccorso e Medicina d'Urgenza)", 'geoPoint': {'lat': 43.90921, 'lon': 12.9164}}, {'city': 'Pozzuoli', 'country': 'Italy', 'facility': "Denominazione: UOC di Medicina e Chirurgia d'Accettazione e d'Urgenza dell'Ospedale Santa Maria delle Grazie di Pozzuoli", 'geoPoint': {'lat': 40.84394, 'lon': 14.0952}}, {'city': 'Ravenna', 'country': 'Italy', 'facility': 'Ospedale Santa Maria delle Croci, AUSL della Romagna (U.O. Anestesia e Rianimazione)', 'geoPoint': {'lat': 44.41344, 'lon': 12.20121}}, {'city': 'Reggio Calabria', 'country': 'Italy', 'facility': 'Grande Ospedale Metropolitano, Reggio Calabria', 'geoPoint': {'lat': 38.11047, 'lon': 15.66129}}, {'city': 'Rimini', 'country': 'Italy', 'facility': 'Ospedale Infermi, AUSL della Romagna (U.O. Malattie Infettive)', 'geoPoint': {'lat': 44.05755, 'lon': 12.56528}}, {'city': 'Rome', 'country': 'Italy', 'facility': 'Policlinico Gemelli (U.O.C. Dipartimento Scienze di Laboratorio e Infettivologiche)', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'city': 'Varese', 'country': 'Italy', 'facility': 'ASST Sette Laghi (Dipartimento di Medicina Interna)', 'geoPoint': {'lat': 45.82058, 'lon': 8.82511}}, {'city': 'Varese', 'country': 'Italy', 'facility': 'ASST Sette Laghi (Dipartimento Emergenze ed Urgenze)', 'geoPoint': {'lat': 45.82058, 'lon': 8.82511}}, {'city': 'Varese', 'country': 'Italy', 'facility': 'ASST Sette Laghi (U.O.C. Anestesia e Rianimazione Neurochirurgica e Generale)', 'geoPoint': {'lat': 45.82058, 'lon': 8.82511}}, {'city': 'Varese', 'country': 'Italy', 'facility': 'ASST Sette Laghi (U.O.C. Malattie Infettive e Tropicali)', 'geoPoint': {'lat': 45.82058, 'lon': 8.82511}}, {'city': 'Verona', 'country': 'Italy', 'facility': 'A.O.U. Integrata di Verona (Dip. Malattie Infettive)', 'geoPoint': {'lat': 45.43854, 'lon': 10.9938}}, {'city': 'Villafranca di Verona', 'country': 'Italy', 'facility': 'Ospedale Magalini (U.O. Malattie Infettive)', 'geoPoint': {'lat': 45.35405, 'lon': 10.84462}}], 'overallOfficials': [{'name': 'Francesco Perrone, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'After peer-reviewed publication of the primary results, with no time limits', 'ipdSharing': 'YES', 'description': 'Data will be shared upon reasonable request to the Principal Investigator of the study\n\nThe following IPD will be available for sharing:\n\n1. Baseline characteristics of patients\n2. Treatment data\n3. Safety data\n4. Follow-up data', 'accessCriteria': 'Motivated requests to access to IPD are to be sent by email to the Principal Investigator (f.perrone@istitutotumori.na.it)'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute, Naples', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}