Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2026-03-02 @ 4:22 PM
Study NCT ID:
NCT04357860
Status:
COMPLETED
Last Update Posted:
2021-07-07
First Post:
2020-04-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial of Sarilumab in Adults With COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000592401', 'term': 'sarilumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2021-04-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-06', 'studyFirstSubmitDate': '2020-04-20', 'studyFirstSubmitQcDate': '2020-04-20', 'lastUpdatePostDateStruct': {'date': '2021-07-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ventilation requirements', 'timeFrame': 'At day 28 or when the subject is discharged (whichever occurs first)', 'description': 'Proportion of patients requiring or time (in days) until required:\n\n* High flow nasal oxygenation (HFNO)\n* Non-invasive mechanical ventilation type BiPAP\n* Non-invasive mechanical ventilation type CPAP\n* Invasive mechanical ventilation'}], 'secondaryOutcomes': [{'measure': 'Crude mortality', 'timeFrame': 'At day 28 or when the subject is discharged (whichever occurs first)', 'description': 'Crude mortality at 28 days'}, {'measure': 'Time to clinical improvement', 'timeFrame': 'At day 28 or when the subject is discharged (whichever occurs first)', 'description': 'Time to clinical improvement: defined as the mean change or time in days from randomization to any of the following criteria: (i) improvement of two points on the ordinal scale of 7 points of severity or, (ii) hospital discharge with lifetime. The criteria reached before are used. The 7 point gravity scale includes the following categories:\n\n1. \\- Not hospitalized with normal activity\n2. \\- Not hospitalized but unable to have normal activity\n3. \\- Hospitalized, without requiring oxygen supplementation\n4. \\- Hospitalized, requiring oxygen supplementation\n5. \\- Hospitalized, requiring ONAF, non-invasive mechanical ventilation or both\n6. \\- Hospitalized requiring ECMO, invasive mechanical ventilation or both\n7. \\- Death'}, {'measure': 'Time until improvement in oxygenation', 'timeFrame': 'At day 28 or when the subject is discharged (whichever occurs first)', 'description': 'Time (in days) until improvement in oxygenation for at least 48 hours:\n\n* Time to verify an increase in the SpO2 / FiO2 ratio with respect to the worst SpO2 / FiO2 prior to treatment with Sarilumab and stratified according to levels of IL-6 or DD\n* Time to absence of oxygen requirement to maintain saturation in ambient air ≥ 93%\n* Number of days in need of supplemental oxygen'}, {'measure': 'Proportion of patients requiring invasive mechanical ventilation', 'timeFrame': 'At day 28 or when the subject is discharged (whichever occurs first)', 'description': 'Proportion of patients requiring invasive mechanical ventilation in the trial'}, {'measure': 'Proportion of patients having negative COVID-19 CRP at each visit', 'timeFrame': 'At day 28 or when the subject is discharged (whichever occurs first)', 'description': 'Proportion of patients having negative COVID-19 CRP at each visit of the trial'}, {'measure': 'Mean of serum cytokine levels', 'timeFrame': 'At day 28 or when the subject is discharged (whichever occurs first)', 'description': 'Mean of serum cytokine levels: the panel of cytokines to quantify; IL1-��, IL1-β, IL6, IL8, IL10, IL12, IL18, IL38, INFɣ, TNF��, CCL2, CCL3, CCL4, MIF and PAI-1'}, {'measure': 'Adverse events related to medication and its administration', 'timeFrame': 'At day 28 or when the subject is discharged (whichever occurs first)', 'description': 'Incidence of adverse events related to medication and its administration'}, {'measure': 'Incidence in the appearance of serious bacterial, fungal or opportunistic infections', 'timeFrame': 'At day 28 or when the subject is discharged (whichever occurs first)', 'description': 'Incidence in the appearance of serious bacterial, fungal or opportunistic infections in the subjects'}, {'measure': 'Incidence of perforation of the gastrointestinal tract', 'timeFrame': 'At day 28 or when the subject is discharged (whichever occurs first)', 'description': 'Incidence of perforation of the gastrointestinal tract in subjects'}, {'measure': 'Leukocyte and neutrophil count', 'timeFrame': 'At day 28 or when the subject is discharged (whichever occurs first)', 'description': 'Leukocyte and neutrophil count mean'}, {'measure': 'Hemoglobin levels', 'timeFrame': 'At day 28 or when the subject is discharged (whichever occurs first)', 'description': 'Mean hemoglobin levels'}, {'measure': 'Platelet count', 'timeFrame': 'At day 28 or when the subject is discharged (whichever occurs first)', 'description': 'Platelet count mean'}, {'measure': 'Levels of creatinemia', 'timeFrame': 'At day 28 or when the subject is discharged (whichever occurs first)', 'description': 'Average levels of creatinemia'}, {'measure': 'Bilirubin levels', 'timeFrame': 'At day 28 or when the subject is discharged (whichever occurs first)', 'description': 'Average bilirubin levels'}, {'measure': 'ALT and AST levels', 'timeFrame': 'At day 28 or when the subject is discharged (whichever occurs first)', 'description': 'ALT and AST average levels'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['SARS-CoV 2', 'SARS']}, 'referencesModule': {'references': [{'pmid': '34902262', 'type': 'DERIVED', 'citation': 'Merchante N, Carcel S, Garrido-Gracia JC, Trigo-Rodriguez M, Moreno MAE, Leon-Lopez R, Espindola-Gomez R, Alonso EA, Garcia DV, Romero-Palacios A, Perez-Camacho I, Gutierrez-Gutierrez B, Martinez-Marcos FJ, Fernandez-Roldan C, Perez-Crespo PMM, Cano AA, Leon E, Corzo JE, de la Fuente C, Torre-Cisneros J. Early Use of Sarilumab in Patients Hospitalized with COVID-19 Pneumonia and Features of Systemic Inflammation: the SARICOR Randomized Clinical Trial. Antimicrob Agents Chemother. 2022 Feb 15;66(2):e0210721. doi: 10.1128/AAC.02107-21. Epub 2021 Dec 13.'}, {'pmid': '33191263', 'type': 'DERIVED', 'citation': 'Leon Lopez R, Fernandez SC, Limia Perez L, Romero Palacios A, Fernandez-Roldan MC, Aguilar Alonso E, Perez Camacho I, Rodriguez-Bano J, Merchante N, Olalla J, Esteban-Moreno MA, Santos M, Luque-Pineda A, Torre-Cisneros J. Efficacy and safety of early treatment with sarilumab in hospitalised adults with COVID-19 presenting cytokine release syndrome (SARICOR STUDY): protocol of a phase II, open-label, randomised, multicentre, controlled clinical trial. BMJ Open. 2020 Nov 14;10(11):e039951. doi: 10.1136/bmjopen-2020-039951.'}]}, 'descriptionModule': {'briefSummary': 'Early administration of sarilumab in hospitalized patients infected with COVID-19 who have pulmonary infiltrates and are at high risk of unfavorable evolution could decrease/prevent progression to acute respiratory distress syndrome (ARDS) requiring high flow nasal oxygenation (HFNO) or either invasive or non-invasive mechanical ventilation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age ≥ 18 years and \\<75 years\n* Admission for confirmed respiratory symptoms to COVID-19 based on a positive PCR in a sample of the respiratory tract in the local laboratory in the absence of respiratory distress syndrome requiring ONAF or mechanical ventilation\n* Interstitial pneumonia confirmed by chest radiography or CT\n* IL-6 levels\\> 40 pg / ml. In its absence, D-Dimer (DD)\\> 1500 or\\> 1000 may be included if progressive increases are documented\n* Negative pregnancy test in women of childbearing age\n* Signature of informed consent\n\nExclusion Criteria:\n\n* SOFA score\\> 6 points\n* Patient who, in the researcher's opinion, is not a subsidiary of invasive mechanical ventilation\n* Neutrophil count \\<2 x 103 / μL\n* Platelet count \\<100 x 103 / μL\n* ALT or AST levels\\> 5 times the upper limit of normal\n* Severe renal failure (CrCr \\<30 ml / min)\n* Active bacterial infectious process\n* Active tuberculosis, history of not completing treatment against tuberculosis, suspicion of extrapulmonary tuberculosis\n* History of intestinal ulcer or diverticulitis\n* History of hypersensitivity reactions to Sarilumab or its excipients\n* Treatment with TNF antagonists\n* Previous treatment with anti-IL6 in the previous 30 days\n* Chronic prior treatment with corticosteroids at doses greater than 0.5 mg / kg / day of prednisone or equivalent. Yes, inhaled and topical corticosteroids are acceptable\n* Concomitant treatment with immunomodulators, among which are Vitamin D or statins. Macrolides such as azithromycin are acceptable\n* Patients on immunosuppressive treatment for any cause\n* HIV-infected patients with CD4 \\<200 / mm3\n* Past or current history of autoimmune disease or systemic inflammatory disease\n* Patients who have received or are planning therapy with immunomodulatory antibodies, including immunoglobulins\n* Participation in any clinical trial that evaluated any investigational product in the last 3 months or less than 5 half-lives of the investigational product\n* Pregnancy\n* Any other condition that, in clinical judgment, prevents adherence to the patient's protocol"}, 'identificationModule': {'nctId': 'NCT04357860', 'acronym': 'SARICOR', 'briefTitle': 'Clinical Trial of Sarilumab in Adults With COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'Maimónides Biomedical Research Institute of Córdoba'}, 'officialTitle': 'Clinical Trial of Sarilumab in Adults Hospitalized With COVID-19 Presenting Cytokine Release Syndrome', 'orgStudyIdInfo': {'id': 'SARICOR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sarilumab 200 mg', 'description': 'Subjects treated with the best available treatment up to 14 days plus Sarilumab 200 mg single dose.', 'interventionNames': ['Drug: Sarilumab 200 MG/1.14 ML Subcutaneous Solution [KEVZARA]']}, {'type': 'EXPERIMENTAL', 'label': 'Sarilumab 400 mg', 'description': 'Subjects treated with the best available treatment up to 14 days plus Sarilumab 400 mg single dose.', 'interventionNames': ['Drug: Sarilumab 400 MG/2.28 ML Subcutaneous Solution [KEVZARA]']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Subjects treated with the best available treatment up to 14 days.', 'interventionNames': ['Drug: Best available treatment']}], 'interventions': [{'name': 'Sarilumab 200 MG/1.14 ML Subcutaneous Solution [KEVZARA]', 'type': 'DRUG', 'description': 'Best available treatment up to 14 days plus Sarilumab 200 mg', 'armGroupLabels': ['Sarilumab 200 mg']}, {'name': 'Sarilumab 400 MG/2.28 ML Subcutaneous Solution [KEVZARA]', 'type': 'DRUG', 'description': 'Best available treatment up to 14 days plus Sarilumab 400 mg', 'armGroupLabels': ['Sarilumab 400 mg']}, {'name': 'Best available treatment', 'type': 'DRUG', 'description': 'Best available treatment up to 14 days', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14004', 'city': 'Córdoba', 'country': 'Spain', 'facility': 'Hospital Universitario Reina Sofía', 'geoPoint': {'lat': 37.89155, 'lon': -4.77275}}], 'overallOfficials': [{'name': 'Julián de la Torre Cisneros, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hospital Universitario Reina Sofía'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'After the end of the trial.', 'ipdSharing': 'YES', 'description': 'All the information will be published and it will be available in open access.', 'accessCriteria': 'Contact uicec@imibic.org'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maimónides Biomedical Research Institute of Córdoba', 'class': 'OTHER'}, 'collaborators': [{'name': 'Junta de Andalucia', 'class': 'OTHER_GOV'}, {'name': 'Red Andaluza de Ensayos Clínicos en Enfermedades Infecciosas (Red ANCRAID)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}