Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-26 @ 12:02 AM
Study NCT ID:
NCT04332094
Status:
UNKNOWN
Last Update Posted:
2021-05-06
First Post:
2020-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial of the Use of Tocilizumab for Treatment of SARS-CoV-2 Infection (COVID-19)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C502936', 'term': 'tocilizumab'}, {'id': 'D006886', 'term': 'Hydroxychloroquine'}, {'id': 'D017963', 'term': 'Azithromycin'}], 'ancestors': [{'id': 'D002738', 'term': 'Chloroquine'}, {'id': 'D000634', 'term': 'Aminoquinolines'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D004917', 'term': 'Erythromycin'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 276}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-04-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2021-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-05-03', 'studyFirstSubmitDate': '2020-03-31', 'studyFirstSubmitQcDate': '2020-04-01', 'lastUpdatePostDateStruct': {'date': '2021-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'In-hospital mortality', 'timeFrame': 'Through hospitalization, an average of 2 weeks'}, {'measure': 'Need for mechanical ventilation in the Intensive Care Unit', 'timeFrame': 'Through hospitalization, an average of 2 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tocilizumab'], 'conditions': ['COVID-19']}, 'descriptionModule': {'briefSummary': 'COVID-19 is a respiratory disease caused by the new coronavirus (SARS-CoV-2) and causes considerable morbidity and mortality.\n\nCurrently, there is no vaccine or therapeutic agent to prevent and treat a SARS-CoV-2 infection. This clinical trial is designed to evaluate the use of Tocilizumab in combination with hydroxychloroquine and azithromycin for the treatment of hospitalized adult patients with COVID-19.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject (or authorized legal representative) who can provide written informed consent before beginning any study procedure.\n* Understand and agree to abide by the study procedures.\n* Adult #18 years of age at the time of inclusion in the study.\n* Confirmation of SARS-CoV-2 infection by a microbiological test performed before randomization, no longer than 72 hours.\n* Severity 3-4 according to the WHO 7-point ordinal scale.\n\nExclusion Criteria:\n\n* ALT / AST\\> 5 times the normal limit\n* Stage 4 chronic kidney disease (GFR \\<30) or requiring dialysis.\n* Presence of comorbidities that imply a poor prognosis (according to clinical judgment).\n* Advanced dementia.\n* Pregnancy or breastfeeding.\n* Anticipation of transfer to another center in the 12 hours at the beginning of the study.\n* Allergy to study medication.\n* Serious or active bacterial infections or documented sepsis by pathogens other than SARS-CoV-2.\n* Streptococcus pneumoniae antigenuria positive before study start.\n* Neutropenia \\<500 / mm3.\n* Thrombocytopenia \\<100,000 / mm3.\n* History of diverticulosis.\n* Ongoing skin infection (eg, pyodermitis).\n* Transplanted patient under immunosuppressive treatment.\n* Previous evidence of latent untreated tuberculosis.'}, 'identificationModule': {'nctId': 'NCT04332094', 'acronym': 'TOCOVID', 'briefTitle': 'Clinical Trial of the Use of Tocilizumab for Treatment of SARS-CoV-2 Infection (COVID-19)', 'organization': {'class': 'OTHER', 'fullName': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau"}, 'officialTitle': 'Pilot, Randomized, Multicenter, Open-label Clinical Trial of the Use of Tocilizumab for Treatment of SARS-CoV-2 Infection (COVID-19)', 'orgStudyIdInfo': {'id': 'IIBSP-COV-2020-23'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Early administration of tocilizumab associated with hydroxychloroquine and azithromycin.', 'interventionNames': ['Drug: Tocilizumab', 'Drug: Hydroxychloroquine', 'Drug: Azithromycin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Treatment of SARS-COV-2 (COVID-19) infection with hydroxychloroquine and azithromycin.', 'interventionNames': ['Drug: Hydroxychloroquine', 'Drug: Azithromycin']}], 'interventions': [{'name': 'Tocilizumab', 'type': 'DRUG', 'description': '162 mg sc x 2 doses + tocilizumab 162mg sc x 2 doses at 12 hours (day 1)', 'armGroupLabels': ['Intervention']}, {'name': 'Hydroxychloroquine', 'type': 'DRUG', 'description': '400 mg / 12h v.o. day 1 followed by 200 mg / 12h v.o. for 6 days (7 days in total)', 'armGroupLabels': ['Control', 'Intervention']}, {'name': 'Azithromycin', 'type': 'DRUG', 'description': '500 mg / day v.o. for 3 days', 'armGroupLabels': ['Control', 'Intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Oviedo', 'state': 'Principality of Asturias', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Victor Asensi', 'role': 'CONTACT'}], 'facility': 'Hospital Universitario Central de Asturias', 'geoPoint': {'lat': 43.36029, 'lon': -5.84476}}, {'city': 'Alicante', 'state': 'Valencia', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Esperanza Merino', 'role': 'CONTACT'}], 'facility': 'Hospital General Universitario de Alicante', 'geoPoint': {'lat': 38.34517, 'lon': -0.48149}}, {'city': 'Elche', 'state': 'Valencia', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Felix Gutierrez', 'role': 'CONTACT'}], 'facility': 'Hospital General Universitario de Elche', 'geoPoint': {'lat': 38.26218, 'lon': -0.70107}}, {'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Pere Domingo, MD, PhD', 'role': 'CONTACT', 'email': 'pdomingo@santpau.cat'}, {'name': 'Pere Domingo, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital de la Santa Creu i Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Juan Pablo Horcajada', 'role': 'CONTACT'}], 'facility': 'Hospital del Mar', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Ana Coloma', 'role': 'CONTACT'}], 'facility': 'Hospital Sant Joan Despí', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Vicente Estrada', 'role': 'CONTACT'}], 'facility': 'Hospital Clinico San Carlos', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'centralContacts': [{'name': 'Pere Domingo, MD, PhD', 'role': 'CONTACT', 'email': 'pdomingo@santpau.cat'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau", 'class': 'OTHER'}, 'collaborators': [{'name': 'Instituto de Salud Carlos III', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}