Nctid:
NCT06233357
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "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"}], "browseLeaves"=>[{"id"=>"M10283", "name"=>"Infections", "relevance"=>"LOW"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M2561", "name"=>"COVID-19", "asFound"=>"COVID-19", "relevance"=>"HIGH"}, {"id"=>"M19010", "name"=>"Critical Illness", "asFound"=>"Critically Ill", "relevance"=>"HIGH"}, {"id"=>"M10293", "name"=>"Inflammation", "relevance"=>"LOW"}, {"id"=>"M13904", "name"=>"Pneumonia", "relevance"=>"LOW"}, {"id"=>"M13914", "name"=>"Pneumonia, Viral", "relevance"=>"LOW"}, {"id"=>"M14978", "name"=>"Respiratory Tract Infections", "relevance"=>"LOW"}, {"id"=>"M17522", "name"=>"Virus Diseases", "relevance"=>"LOW"}, {"id"=>"M20490", "name"=>"Coronavirus Infections", "relevance"=>"LOW"}, {"id"=>"M6555", "name"=>"Coronaviridae Infections", "relevance"=>"LOW"}, {"id"=>"M23685", "name"=>"Nidovirales Infections", "relevance"=>"LOW"}, {"id"=>"M15149", "name"=>"RNA Virus Infections", "relevance"=>"LOW"}, {"id"=>"M11168", "name"=>"Lung Diseases", "relevance"=>"LOW"}, {"id"=>"M14977", "name"=>"Respiratory Tract Diseases", "relevance"=>"LOW"}, {"id"=>"M22700", "name"=>"Disease Attributes", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Respiratory Tract (Lung and Bronchial) Diseases", "abbrev"=>"BC08"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"C000711751", "term"=>"Casirivimab and imdevimab drug combination"}], "ancestors"=>[{"id"=>"D000998", "term"=>"Antiviral Agents"}, {"id"=>"D000890", "term"=>"Anti-Infective Agents"}], "browseLeaves"=>[{"id"=>"M4225", "name"=>"Antibodies", "relevance"=>"LOW"}, {"id"=>"M10184", "name"=>"Immunoglobulins", "relevance"=>"LOW"}, {"id"=>"M353274", "name"=>"Casirivimab and imdevimab drug combination", "asFound"=>"Mucopolysaccharide", "relevance"=>"HIGH"}, {"id"=>"M4314", "name"=>"Antiviral Agents", "relevance"=>"LOW"}, {"id"=>"M4214", "name"=>"Anti-Infective Agents", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}]}}, "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"}}}}
