Nctid:
NCT06223984
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000086382", "term"=>"COVID-19"}], "ancestors"=>[{"id"=>"D000011024", "term"=>"Pneumonia, Viral"}, {"id"=>"D000011014", "term"=>"Pneumonia"}, {"id"=>"D000012141", "term"=>"Respiratory Tract Infections"}, {"id"=>"D000007239", "term"=>"Infections"}, {"id"=>"D000014777", "term"=>"Virus Diseases"}, {"id"=>"D000018352", "term"=>"Coronavirus Infections"}, {"id"=>"D000003333", "term"=>"Coronaviridae Infections"}, {"id"=>"D000030341", "term"=>"Nidovirales Infections"}, {"id"=>"D000012327", "term"=>"RNA Virus Infections"}, {"id"=>"D000008171", "term"=>"Lung Diseases"}, {"id"=>"D000012140", "term"=>"Respiratory Tract Diseases"}], "browseLeaves"=>[{"id"=>"M2561", "name"=>"COVID-19", "asFound"=>"COVID-19", "relevance"=>"HIGH"}, {"id"=>"M13904", "name"=>"Pneumonia", "relevance"=>"LOW"}, {"id"=>"M13914", "name"=>"Pneumonia, Viral", "relevance"=>"LOW"}, {"id"=>"M10283", "name"=>"Infections", "relevance"=>"LOW"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "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"}], "browseBranches"=>[{"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"Respiratory Tract (Lung and Bronchial) Diseases", "abbrev"=>"BC08"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M14120", "name"=>"Prednisolone", "relevance"=>"LOW"}, {"id"=>"M11749", "name"=>"Methylprednisolone", "relevance"=>"LOW"}, {"id"=>"M1833", "name"=>"Methylprednisolone Acetate", "relevance"=>"LOW"}, {"id"=>"M11750", "name"=>"Methylprednisolone Hemisuccinate", "relevance"=>"LOW"}, {"id"=>"M229449", "name"=>"Prednisolone acetate", "relevance"=>"LOW"}, {"id"=>"M211887", "name"=>"Prednisolone hemisuccinate", "relevance"=>"LOW"}, {"id"=>"M248881", "name"=>"Prednisolone phosphate", "relevance"=>"LOW"}, {"id"=>"M4225", "name"=>"Antibodies", "relevance"=>"LOW"}, {"id"=>"M10184", "name"=>"Immunoglobulins", "relevance"=>"LOW"}, {"id"=>"M4548", "name"=>"Aspirin", "relevance"=>"LOW"}, {"id"=>"M9579", "name"=>"Heparin", "relevance"=>"LOW"}, {"id"=>"M46053", "name"=>"Calcium heparin", "relevance"=>"LOW"}, {"id"=>"M19117", "name"=>"Immunoglobulins, Intravenous", "relevance"=>"LOW"}, {"id"=>"M8836", "name"=>"gamma-Globulins", "relevance"=>"LOW"}, {"id"=>"M20191", "name"=>"Rho(D) Immune Globulin", "relevance"=>"LOW"}, {"id"=>"M9940", "name"=>"Hydroxychloroquine", "relevance"=>"LOW"}, {"id"=>"M353642", "name"=>"Favipiravir", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Anti-Inflammatory Agents", "abbrev"=>"Infl"}, {"name"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Antiemetics", "abbrev"=>"AnEm"}, {"name"=>"Neuroprotective Agents", "abbrev"=>"NeuroAg"}, {"name"=>"Gastrointestinal Agents", "abbrev"=>"Gast"}, {"name"=>"Antipyretics", "abbrev"=>"Antipy"}, {"name"=>"Antirheumatic Agents", "abbrev"=>"ARhu"}, {"name"=>"Fibrinolytic Agents", "abbrev"=>"FiAg"}, {"name"=>"Analgesics", "abbrev"=>"Analg"}, {"name"=>"Platelet Aggregation Inhibitors", "abbrev"=>"PlAggInh"}, {"name"=>"Anticoagulants", "abbrev"=>"AnCoag"}, {"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE4"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"DOUBLE", "whoMasked"=>["INVESTIGATOR", "OUTCOMES_ASSESSOR"]}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>178}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2020-03-30", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2020-11-14", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-01-23", "studyFirstSubmitDate"=>"2024-01-23", "studyFirstSubmitQcDate"=>"2024-01-23", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-25", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-25", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2020-11-14", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"absolute lymphocyte , white blood cell , neutrophil , ferritin , dimer , crp counts", "timeFrame"=>"on the first day of hospitalization, in the middle and at discharge from intensive care", "description"=>"counts on the first day of hospitalization, in the middle and at discharge from intensive care"}, {"measure"=>"SOFA score", "timeFrame"=>"Day 1", "description"=>"SOFA score at Day 1, with scores range from 0 to 24 and higher score means worse outcome"}, {"measure"=>"all cause mortality rate", "timeFrame"=>"28 days", "description"=>"died at day 28"}, {"measure"=>"ventilation free days", "timeFrame"=>"28 days"}, {"measure"=>"ICU free days", "timeFrame"=>"28 days"}, {"measure"=>"invasive and non-invasive respiratory support", "timeFrame"=>"28 days", "description"=>"intubated"}, {"measure"=>"vasopressor support", "timeFrame"=>"28 days", "description"=>"vasopressor support needs"}, {"measure"=>"renal replacement therapy", "timeFrame"=>"28 days", "description"=>"renal replacement therapy needs"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Pulse Steroid and Immunoglobulins Drugs in Covid 19 Patients"]}, "descriptionModule"=>{"briefSummary"=>"In December 2019, SARS-COV-2 was isolated from patients for the first time . It then rapidly turned into a pandemic affecting the whole world.While most Covid patients survive the disease with mild symptoms, some may develop severe organ failure and respiratory failure requiring mechanical ventilation. COVİD-19 pneumonia may progress into acute respiratory distress syndrome (ARDS). The most important reason for this has been shown in studies; is thought to be because a group of patients develop a cytokine storm-associated hyperinflammatory state characterized by features of macrophage activation syndrome (MAS). The aim of this study was to evaluate the clinical outcomes of the combined use of pulse steroid and intravenous immunoglobulin therapy in patients with severe COVID-19 with severe respiratory distress in intensive care unit.", "detailedDescription"=>"In December 2019, SARS-COV-2 was isolated from patients for the first time . It then rapidly turned into a pandemic affecting the whole world.While most Covid patients survive the disease with mild symptoms, some may develop severe organ failure and respiratory failure requiring mechanical ventilation . COVİD-19 pneumonia may progress into acute respiratory distress syndrome (ARDS) , diffuse alveolar damage, and vascular endothelitis, which is comlicated with trombosis and hemorrhage. .\n\nThe most important reason for this has been shown in studies; is thought to be because a group of patients develop a cytokine storm-associated hyperinflammatory state characterized by features of macrophage activation syndrome (MAS), such as lymphopenia, elevated ferritin and elevated d-dimer. Increased proinflammatory cytokine release, especially as a result of stimulation of the immune system, has been shown to be associated with this hyperinflammatory phase .\n\nThe immune system triggered by viral infections is essential for fighting pathogens. However, the excessive production of pro-inflammatory cytokines caused by SARS-COV-2 can cause tissue damage that can lead to fatal acute respiratory distress .\n\nTherefore, aiming to suppress the cytokine storm seems to be of critical importance for COVID-19 and similar respiratory infections that cause acute respiratory distress . Many agents have been used for this purpose, but there is no clear evidence for the management and treatment of cytokine storm.\n\nImmunosuppression plays an important role in the treatment of cytokine storm. Studies have reported positive results of steroids used for this purpose in elderly COVID-19 patients . Various immunomodulatory agents have also been used for this purpose. In addition to treatments targeting a specific molecule such as IL-6, IL-1, agents that affect various branches of the immune inflammatory system such as intravenous immunoglobulin can be used .\n\nThe aim of this study was to evaluate the clinical outcomes of the combined use of pulse steroid and intravenous immunoglobulin therapy in patients with severe COVID-19 with severe respiratory distress in intensive care unit."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "genderBased"=>true, "genderDescription"=>"18 Years and older (Adult, Older Adult )", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Adult patients with 2019-ncov infection confirmed by PCR;\n* Absolute value of lymphocytes \\< 0. 6x 109/L;\n* Brescia-COVID respiratory severity scale (BCRSS) score ≥3\n* Hyperinflammation (defined as elevation of C-reactive protein (CRP) ≥50 mg/L or ferritin ≥500 ng/ ml)\n* Severe respiratory failure within 48 hours and requires admission to ICU. (severe respiratory failure was defined as PaO2/FiO2 \\< 300 mmHg and was supported by positive pressure mechanical ventilation (including non-invasive and invasive mechanical ventilation, PEEP\\>=5cmH2O))\n\nExclusion Criteria:\n\n* Age \\< 18\n* Pregnant\n* Allergic to experimental drugs\n* The underlying disease is very serious and the expected survival time is less than 6 months (such as advanced malignant tumor);\n* COPD or end-stage lung disease requires home oxygen therapy\n* Expected survival time not exceeding 48 hours\n* Autoimmune diseases"}, "identificationModule"=>{"nctId"=>"NCT06223984", "briefTitle"=>"Combined Use of Immunoglobulin and Pulse Steroid Therapies in Severe Covid-19 Patients", "organization"=>{"class"=>"OTHER", "fullName"=>"Konya City Hospital"}, "officialTitle"=>"Evaluation of the Retrospective Clinical Results of the Combined Use of Immunoglobulin and Pulse Steroid Therapies in Severe Covid-19 Patients Followed in Intensive Care Unit", "orgStudyIdInfo"=>{"id"=>"konya city hospital,konya"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"ACTIVE_COMPARATOR", "label"=>"the group receiving standard treatment", "description"=>"In the group receiving standard treatment, hydroxychloroquine (400 mg/day for 5 days), low moleculer weight heparin, acetylsalicylic acid, favipiravir (3200 mg on day 1, 1200 mg on days 2-5).", "interventionNames"=>["Drug: pulse steroid and nanogam"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"the group receiving IVIG and pulse steroid", "description"=>"In the IVIG and pulse steroid group, patients received pulse steroid (250 mg/day methylprednisolone for 5 days) and intravenous immunoglobulin (400 mg/kg/day for 5 days) in addition to standard treatment. The IVIG preparations given to the patients were in 100 ml volume and 10% concentration, and the commercial name was Nanogam.", "interventionNames"=>["Drug: pulse steroid and nanogam"]}], "interventions"=>[{"name"=>"pulse steroid and nanogam", "type"=>"DRUG", "description"=>"patients received pulse steroid and ivig treatments in addition to standard treatment.", "armGroupLabels"=>["the group receiving IVIG and pulse steroid", "the group receiving standard treatment"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"42020", "city"=>"Konya", "country"=>"Turkey", "facility"=>"Konya City Hospital", "geoPoint"=>{"lat"=>37.87135, "lon"=>32.48464}}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"UNDECIDED"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Konya City Hospital", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"specialist doctor", "investigatorFullName"=>"Dursun Elmas", "investigatorAffiliation"=>"Konya City Hospital"}}}}
