Ignite Creation Date:
2025-12-24 @ 7:16 PM
Ignite Modification Date:
2025-12-29 @ 11:50 PM
Study NCT ID:
NCT04361903
Status:
UNKNOWN
Last Update Posted:
2020-04-24
First Post:
2020-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ruxolitinib for the Treatment of Acute Respiratory Distress Syndrome in Patients With COVID-19 Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}, {'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C540383', 'term': 'ruxolitinib'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 13}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-04-25', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-04-23', 'studyFirstSubmitDate': '2020-04-14', 'studyFirstSubmitQcDate': '2020-04-23', 'lastUpdatePostDateStruct': {'date': '2020-04-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-24', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients who avoid mechanical assisted ventilation in acute respiratory distress syndrome in patients with SARS-CoV-2 COVID-19', 'timeFrame': '15 days', 'description': 'Number of patients who avoid mechanical assisted ventilation in acute respiratory distress syndrome in patients with SARS-CoV-2 COVID-19 with rapid deterioration of respiratory parameters in the last 12 hours'}], 'secondaryOutcomes': [{'measure': 'Improvement of respiratory performance - Arterial Blood Gas Analisys - pH', 'timeFrame': '15 days', 'description': 'ABG (arterial Blood Gas): pH as SI Unit, every 12 hours and in any case in the presence of significant clinical variations.'}, {'measure': 'Improvement of respiratory performance - Arterial Blood Gas Analisys - pO2', 'timeFrame': '15 days', 'description': 'ABG (arterial Blood Gas): pO2 in mm Hg, every 12 hours and in any case in the presence of significant clinical variations.'}, {'measure': 'Improvement of respiratory performance - Arterial Blood Gas Analisys - pCO2', 'timeFrame': '15 days', 'description': 'ABG (arterial Blood Gas): pCO2 in mm Hg, every 12 hours and in any case in the presence of significant clinical variations.'}, {'measure': 'Improvement of respiratory performance - ratio values', 'timeFrame': '15 days', 'description': 'PaO2 / FiO2, SatO2 ratio. Vital parameters and respiratory function every 12 hours and in any case in the presence of significant clinical variations.'}, {'measure': 'Evaluation of known adverse events related to the use of the drug - D-Dimer', 'timeFrame': '15 days', 'description': 'every 24 hours D-Dimer value in mgr/ml'}, {'measure': 'Evaluation of known adverse events related to the use of the drug - fibrinogen', 'timeFrame': '15 days', 'description': 'every 24 hours fibrinogen value in mg/dl'}, {'measure': 'Evaluation of known adverse events related to the use of the drug - transaminases', 'timeFrame': '15 days', 'description': 'every 24 hours transaminases value in U/L'}, {'measure': 'Evaluation of known adverse events related to the use of the drug - aPTT', 'timeFrame': '15 days', 'description': 'every 24 hours aPTT value in seconds'}, {'measure': 'Evaluation of known adverse events related to the use of the drug - INR', 'timeFrame': '15 days', 'description': 'every 24 hours INR value in %'}, {'measure': 'Evaluation of known adverse events related to the use of the drug - glycemia', 'timeFrame': '15 days', 'description': 'every 24 hours glycemia value in mg/dl'}, {'measure': 'Evaluation of known adverse events related to the use of the drug - creatinine', 'timeFrame': '15 days', 'description': 'every 24 hours creatinine serum value in mg/dl'}, {'measure': 'Evaluation of known adverse events related to the use of the drug - Leucocytes count', 'timeFrame': '15 days', 'description': 'Total leucocyte as CBC x10e)/L'}, {'measure': 'Evaluation of known adverse events related to the use of the drug - Leucocytes formula', 'timeFrame': '15 days', 'description': 'formula % on total leucocyte'}, {'measure': 'Evaluation of the epidemiological parameters: Chest CT', 'timeFrame': '15 days', 'description': 'Thoracic imaging, every 48 h: presence, extension and dimension on lung thickening - Chest CT at start and end of treatment, Time elapsed between the onset of clinical symptoms and hospitalization.'}, {'measure': 'Evaluation of the epidemiological parameters: Eco Chest', 'timeFrame': '15 days', 'description': 'Thoracic imaging: every day: presence and number of line B every 48 hours.Time elapsed between the onset of clinical symptoms and hospitalization.'}, {'measure': 'Evaluation of the epidemiological parameters: CHEST X-ray', 'timeFrame': '15 days', 'description': 'Thoracic imaging: presence, extension and dimension on lung thickening - Chest X-ray, Time elapsed between the onset of clinical symptoms and hospitalization.'}, {'measure': 'Monitoring of Serum levels of cytokines before and every 48 h from start to to end of treatment', 'timeFrame': '15 days', 'description': 'Monitoring of serum cytokines (IL-6 in pgr/dL, TNF in pgr/dL) every 48 h'}, {'measure': 'Monitoring incidence of treatment Emergent Adverse Events of ruxolitinib therapy', 'timeFrame': '15 days', 'description': 'Number of AE grade 1 to 4'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ruxolitinib', 'Acute Respiratory Distress Syndrome', 'COVID-19'], 'conditions': ['Severe Acute Respiratory Syndrome Coronavirus 2']}, 'referencesModule': {'references': [{'pmid': '32850921', 'type': 'DERIVED', 'citation': 'Capochiani E, Frediani B, Iervasi G, Paolicchi A, Sani S, Roncucci P, Cuccaro A, Franchi F, Simonetti F, Carrara D, Bertaggia I, Nasso D, Riccioni R, Scolletta S, Valente S, Conticini E, Gozzetti A, Bocchia M. Ruxolitinib Rapidly Reduces Acute Respiratory Distress Syndrome in COVID-19 Disease. Analysis of Data Collection From RESPIRE Protocol. Front Med (Lausanne). 2020 Aug 4;7:466. doi: 10.3389/fmed.2020.00466. eCollection 2020.'}]}, 'descriptionModule': {'briefSummary': 'It is an observational, cohort, retrospective, monocentric, non-profit study. The primary objective is to evaluate the efficacy and safety of ruxolitinib in acute respiratory distress syndrome in patients with SARS-CoV-2 COVID-19 with rapid deterioration of respiratory parameters in the last 12 hours.', 'detailedDescription': 'It is an observational, cohort, retrospective, monocentric, non-profit study. Patients with SARS-CoV-2 COVID-19 pneumonia who started off-label Ruxolitinib treatment in the period between 25/03/2020 and 07/04/2020 in hospitalization in the COVID-19 wards of the USL Toscana Nord Ovest company.\n\nPrimary objective\n\n\\- Evaluation of the efficacy and safety of ruxolitinib in acute respiratory distress syndrome in patients with SARS-CoV-2 COVID-19 with rapid deterioration of respiratory parameters in the last 12 hours.\n\nSecondary objectives\n\n* Improvement of respiratory performance.\n* Improvement of acute phase inflammation indices.\n* Evaluation of known adverse events related to the use of the drug.\n* Evaluation of the epidemiological parameters in COVID-19 patients.\n* Monitoring of plasma levels of cytokines before and after treatment. Exploratory objectives\n* Analysis of the outcomes for the launch of a study on the efficacy and safety of Ruxolitinib in the treatment of ADRS in COVID-19 patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with SARS-CoV-2 COVID-19 pneumonia who started off-label ruxolitinib treatment in the period between 03/24/2020 and 07/04/2020, with a dosage of at least 20 mg x 2 / day in the first 48 hours', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* positive analysis for RT PCR (Shanghai BioTec or Sansure Biotech) for SARS-CoV-2 in a respiratory tract sample;\n* Imaging (CT / ECO / RX) positive for pneumonia;\n* Oxygen saturation (SaO2) of 93% or less in the environment;\n* Partial oxygen pressure ratio (PaO2) on inspired oxygen fraction (FiO2) (PaO2 / FiO2) lower than 250 mg / Hg, but not lower than 100 mg / Hg;\n* Rapid clinical evolution with worsening of respiratory parameters in the last 12 hours.\n* Release of informed consent.\n\nExclusion Criteria:\n\n* Pregnancy and breastfeeding;\n* Patients already in assisted breathing with tracheal cannula;\n* Patients with active and uncompensated serious pathologies previously to the COVID 19 infection;\n* Known hypersensitivity to ruxolitinib or to any of the excipients listed in section 6.1 of the SPC;\n* Patients with renal insufficiency;\n* Patients with positive quantiferon;\n* Patients with documented uncontrolled bacterial sepsis (excluding procalcitonin increase in the presence of negative blood cultures);\n* Patients with neutropenia equal to or less than 1000 PMN / mmc;\n* Patients with thrombocytopenia equal to or less than 100000 / mmc.\n* HCV and / or HBV positive patients, HIV.'}, 'identificationModule': {'nctId': 'NCT04361903', 'acronym': 'RESPIRE', 'briefTitle': 'Ruxolitinib for the Treatment of Acute Respiratory Distress Syndrome in Patients With COVID-19 Infection', 'organization': {'class': 'OTHER', 'fullName': 'Azienda USL Toscana Nord Ovest'}, 'officialTitle': 'COVID-19: Ruxolitinib for the Treatment of cytokinE Storm resPiratory dIstREss Syndrome. RESPIRE Study', 'orgStudyIdInfo': {'id': '2020.COVID-19.RUXO106'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients treated with ruxolutinib', 'description': 'SARS-CoV-2 COVID-19 patients with rapid worsening of respiratory parameters in the last 12 hours treated with ruxolutinib, dosage of at least 20 mg x 2 / day in the first 48 hours.', 'interventionNames': ['Drug: Ruxolitinib Oral Tablet']}], 'interventions': [{'name': 'Ruxolitinib Oral Tablet', 'type': 'DRUG', 'description': 'Ruxolitinib Oral Tablet dosage of at least 20 mg x 2 / day in the first 48 hours', 'armGroupLabels': ['Patients treated with ruxolutinib']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Enrico Dr Capochiani, hematologist', 'role': 'CONTACT', 'email': 'enrico.capochiani@uslnordovest.toscana.it', 'phone': '00393473527340'}, {'name': 'Barbara Dr Meini, Pharmacist', 'role': 'CONTACT', 'email': 'barbara.meini@uslnordovest.toscana.it', 'phone': '00390586223031'}], 'overallOfficials': [{'name': 'Enrico Dr Capochiani, hematologist', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Azienda USL Toscana Nord Ovest'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda USL Toscana Nord Ovest', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy', 'class': 'OTHER_GOV'}, {'name': 'Azienda Ospedaliera Universitaria Senese', 'class': 'OTHER'}, {'name': 'Azienda Ospedaliero, Universitaria Pisana', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD Hematologist', 'investigatorFullName': 'Enrico Capochiani', 'investigatorAffiliation': 'Azienda USL Toscana Nord Ovest'}}}}