Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-30 @ 1:14 PM
Study NCT ID:
NCT04577534
Status:
COMPLETED
Last Update Posted:
2021-06-21
First Post:
2020-09-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
COVID-19: Salvage TOcilizumab as a Rescue Measure
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2021-06-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-17', 'studyFirstSubmitDate': '2020-09-03', 'studyFirstSubmitQcDate': '2020-10-05', 'lastUpdatePostDateStruct': {'date': '2021-06-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical status at day 28', 'timeFrame': 'day 28', 'description': '(assessed using 7-category ordinal scale) 7 death 6 in ICU with ECMO/ mechanical ventilation 5 in ICU, no ECMO/ mechanical ventilation 4 in hospital, not ICU, needs supplementary oxygen 3 in hospital, not ICU, no supplementary oxygen 2 not in hospital, but not back to normal\n\n1 not in hospital, back to normal'}], 'secondaryOutcomes': [{'measure': 'Time to clinical improvement', 'timeFrame': '28 days', 'description': 'defined as a National Early Warning Score 2 (NEWS2) of\\>/=2 maintained for 24 hours'}, {'measure': 'Time to decline of at least 2 categories', 'timeFrame': '28 days', 'description': 'relative on a 7-category ordinalscale of clinical status'}, {'measure': 'Incidence of mechanical and/or non-invasive ventilation', 'timeFrame': '28 days', 'description': '(mode and duration of respiratory support) Hospital day when respiratory support needed with non-invasive ventilation - and duration.\n\nHospital day when respiratory support needed by invasive mechanical ventilation -and duration.'}, {'measure': 'Number of ventilator-free days to day 28', 'timeFrame': '28 days', 'description': 'days not in ventilator'}, {'measure': 'Organ failure free days to day 28', 'timeFrame': '28 days', 'description': 'days without organ failure'}, {'measure': 'Incidence of ICU stay', 'timeFrame': '28 days', 'description': 'ICU admission day'}, {'measure': 'Duration of ICU stay', 'timeFrame': '28 days', 'description': 'days on ICU'}, {'measure': 'Time to clinical failure', 'timeFrame': '28 days', 'description': 'time to death, mechanical ventilation, or ICU admission (whichever occurs first)'}, {'measure': 'SAPS II', 'timeFrame': '28 days', 'description': 'during ICU stay SAPS II = simplified acute physiology score II min 0 (best), max 163 (worst)'}, {'measure': 'CCI', 'timeFrame': '28 days', 'description': 'during ICU stay CCI = Charlson Comorbidity Index min 0 (best), max 37 (worst)'}, {'measure': 'APACHE II', 'timeFrame': '28 days', 'description': 'during ICU stay APACHE II = acute physiology and chronic health evaluation II min 0 (best), max 71 (worst)'}, {'measure': 'SOFA 6', 'timeFrame': '28 days', 'description': 'during ICU stay SOFA 6 = sequential organ failure assessment min 0 (best), max 24 (worst)'}, {'measure': 'Mortality rate', 'timeFrame': '28 days', 'description': 'during and end of period of 28 days'}, {'measure': 'Time to hospital discharge or "ready for discharge"', 'timeFrame': '28 days', 'description': 'as evidenced by normal body temperature and respiratory rate and stable oxygen saturation on ambient air or \\</=2 l supplemental oxygen'}, {'measure': 'Duration of supplemental oxygen', 'timeFrame': '28 days', 'description': 'days on suppl oxygen'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19', 'new coronavirus disease', 'tocilizumab'], 'conditions': ['Covid19']}, 'descriptionModule': {'briefSummary': 'Evaluating the efficacy of Tocilizumab in hospitalized patients in the inflammatory phase of COVID-19. Randomization 2:1 (TCZ:standard of care).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* written informed consaent obtained\n* hospitalized with COVID-19 disease\n* Age \\>/= 18 years\n* SARS CoV-2 NhO posit\n* Sp=2 \\</93% on ambient air or respiratory rate \\>30 /min\n* Any 2 of the 4: P-IL-6 \\> 2 x ULN / P-ferritin \\> 2 x ULN / P-FIDD \\>1.5 mg/l / P- CRP \\>40 mg/l without obvious presence of bacterial infection (normal values: P -IL-6 \\<5.9 ng/l; P-ferritin, men 30-400 mikrog/l, women 13-150 mikrog/l ; P-FIDD (Fibrin degradation products, D-dimer) \\<0.5 mg/l; P-CRP \\<10 mg/l)\n\nExclusion Criteria:\n\n* Known severe allergic reactions to monoclonal antibodies\n* Active confirmed tuberculosis with ongoing treatment or obvious tuberculosis or obvious other bacterial, fungal or viral infection (besides COVID-19)\n* In the opinion of the clinical team, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments\n* Long-term oral anti-rejection or immunomodulatory drugs (including corticosteroids equivalent to methylprednison 15mg/day)\n* Pregnant or lactating women. If needed, exclusion of pregnancy should be performed by laboratory test (U-hCG-O).\n* Participating in other drug clinical trials\n* Absolute neutrophil count \\< 1 x10E9/l\n* Platelet count \\<50 x10E9/l\n* ALAT \\>10x ULN'}, 'identificationModule': {'nctId': 'NCT04577534', 'acronym': 'COVIDSTORM', 'briefTitle': 'COVID-19: Salvage TOcilizumab as a Rescue Measure', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Turku University Hospital'}, 'officialTitle': 'COVID-19: Salvage TOcilizumab as a Rescue Measure. Use of Tocilizumab in the Inflammatory Phase of COVID-19 / New Coronavirus Disease', 'orgStudyIdInfo': {'id': 'EudraCT 2020-002039-31'}, 'secondaryIdInfos': [{'id': '2020-002039-31', 'type': 'EUDRACT_NUMBER'}, {'id': 'T124/2020', 'type': 'OTHER', 'domain': 'Turku University Hospital'}, {'id': 'KLnro 36/2020', 'type': 'OTHER', 'domain': 'Fimea'}, {'id': 'dnro 68/06.00.01/2020', 'type': 'OTHER', 'domain': 'TUKIJA / VALVIRA'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tocilizumab (TCZ)', 'description': 'Participants will receive one infusion of iv TCZ (according to weight of patient)', 'interventionNames': ['Drug: iv Tocillizumab (TCZ)']}, {'type': 'NO_INTERVENTION', 'label': 'standard of care (no TCZ)', 'description': 'Participants will receive standard of care'}], 'interventions': [{'name': 'iv Tocillizumab (TCZ)', 'type': 'DRUG', 'description': 'Participants are randomized (2:1) to receive TCZ or Standard of Care', 'armGroupLabels': ['Tocilizumab (TCZ)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20521', 'city': 'Turku', 'country': 'Finland', 'facility': 'Turku University Hospital', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'plan to investigate if it is possible by law'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jarmo Oksi', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Head of Infectious Diseases', 'investigatorFullName': 'Jarmo Oksi', 'investigatorAffiliation': 'Turku University Hospital'}}}}