Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2025-12-25 @ 4:05 PM
Study NCT ID:
NCT06233357
Status:
COMPLETED
Last Update Posted:
2024-02-01
First Post:
2024-01-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Critically Ill ICU Patients Under Casirivimab- and/or Tocilizumab Application
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D016638', 'term': 'Critical Illness'}], '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'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'C000711488', 'term': 'imdevimab'}, {'id': 'C502936', 'term': 'tocilizumab'}, {'id': 'C000711751', 'term': 'casirivimab and imdevimab drug combination'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 95}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-31', 'studyFirstSubmitDate': '2024-01-22', 'studyFirstSubmitQcDate': '2024-01-22', 'lastUpdatePostDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality rates in the 4 groups', 'timeFrame': '28-day mortality', 'description': 'Number of survivors and nonsurvivors'}], 'secondaryOutcomes': [{'measure': 'Leukocyte count in 4 groups', 'timeFrame': '30-days', 'description': 'Routine blood analysis'}, {'measure': 'C-reactive protein in 4 groups', 'timeFrame': '30-days', 'description': 'Routine blood analysis over time'}, {'measure': 'Interleukin 6 serum concentrations in 4 groups', 'timeFrame': '30-days', 'description': 'Routine blood analysis over time'}, {'measure': 'Ferritin serum concentrations in 4 groups', 'timeFrame': '30-days', 'description': 'Routine blood analysis over time'}, {'measure': 'Procalcitonin serum concentrations in 4 groups', 'timeFrame': '30-days', 'description': 'Routine blood analysis over time'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19', 'critically ill', 'ICU', 'casirivimab imdevimab', 'tocilizumab', 'interleukin 6', 'C-reactive protein', 'ferritin', 'procalcitonin', 'mortality'], 'conditions': ['COVID-19', 'Outcome, Fatal', 'Tocilizumab', 'Interleukin 6', 'Critically Ill']}, 'descriptionModule': {'briefSummary': 'In a retrospective observational study, critically ill COVID-19 patients admitted to the ICU with the CoV-2 delta-variant between august 2021 and february 2022 were evaluated (ethics application nr. 129/22 of the ethics commssion of the university Ulm.', 'detailedDescription': 'According to the recommendations, IgG seronegative SARSCoV2-Spike antibody (\\< 0,80 U/ml) COVID-19 patients were treated with 1 dose of subcutaneous casirivimab and imdevimab, 1200 mg (600 mg of each). Patients with CRP \\> 75 mg/l or IL-6 \\> 75 ng/l were treated with one dose of intravenous tocilizumab 8 mg/kg body weight. 28-day mortality and 30-day time course of leukocyte counts and serum concentrations of C-reactive protein (CRP), procalcitonin (PCT), interleukin 6 (IL-6) and ferritin in 4 patient groups, i. e., treated without (N) or with casirivimab / imdevimab (C) or tocilizumab (T), solely, or in combination of both (C + T), were evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'In a retrospective observational study, critically ill COVID-19 patients admitted to the ICU with the CoV-2 delta-variant between august 2021 and february 2022 were evaluated. IgG seronegative SARSCoV2-Spike antibody (\\< 0,80 U/ml) COVID-19 patients were treated with 1 dose of subcutaneous casirivimab and imdevimab, 1200 mg (600 mg of each). Patients with CRP \\> 75 mg/l or IL-6 \\> 75 ng/l were treated with one dose of intravenous tocilizumab 8 mg/kg body weight.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of COVID-19\n* CoV-2 delta-variant\n* critically ill patients\n* ICU\n\nExclusion Criteria:\n\n* tuberculosis\n* active hepatitis\n* HIV'}, 'identificationModule': {'nctId': 'NCT06233357', 'acronym': 'CasiTocCOVID', 'briefTitle': 'Critically Ill ICU Patients Under Casirivimab- and/or Tocilizumab Application', 'organization': {'class': 'OTHER', 'fullName': 'University of Ulm'}, 'officialTitle': 'Course of Inflammation and Infection Markers in Critically Ill ICU Patients Under Casirivimab- and/or Tocilizumab Application', 'orgStudyIdInfo': {'id': 'University Ulm'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'N, no casirivimab / imdevimab or tocilizumab', 'description': 'No intervention'}, {'label': 'C, treated with casirivimab / imdevimab', 'description': 'Active comparator', 'interventionNames': ['Drug: treated without (N), with casirivimab / imdevimab (C) or tocilizumab (T), solely, or in combination of both (C + T)']}, {'label': 'T, Treated with Tocilizumab', 'description': 'Active comparator', 'interventionNames': ['Drug: treated without (N), with casirivimab / imdevimab (C) or tocilizumab (T), solely, or in combination of both (C + T)']}, {'label': 'C + T, treated with casirivimab / imdevimab and tocilizumab', 'description': 'Active comparator', 'interventionNames': ['Drug: treated without (N), with casirivimab / imdevimab (C) or tocilizumab (T), solely, or in combination of both (C + T)']}], 'interventions': [{'name': 'treated without (N), with casirivimab / imdevimab (C) or tocilizumab (T), solely, or in combination of both (C + T)', 'type': 'DRUG', 'otherNames': ['casirivimab / imdevimab', 'tocilizumab'], 'description': 'IgG seronegative SARSCoV2-Spike antibody (\\< 0,80 U/ml) COVID-19 patients were treated with 1 dose of subcutaneous casirivimab and imdevimab, 1200 mg (600 mg of each). Patients with CRP \\> 75 mg/l or IL-6 \\> 75 ng/l were treated with one dose of intravenous tocilizumab 8 mg/kg body weight', 'armGroupLabels': ['C + T, treated with casirivimab / imdevimab and tocilizumab', 'C, treated with casirivimab / imdevimab', 'T, Treated with Tocilizumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '89070', 'city': 'Ulm', 'country': 'Germany', 'facility': 'Clinic of Anesthesiology', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}], 'overallOfficials': [{'name': 'Manfred Weiss, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Ulm'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Ulm', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Manfred Weiss', 'investigatorAffiliation': 'University of Ulm'}}}}