Ignite Creation Date:
2025-12-24 @ 2:43 PM
Ignite Modification Date:
2026-01-02 @ 2:04 AM
Study NCT ID:
NCT05604859
Status:
UNKNOWN
Last Update Posted:
2023-07-21
First Post:
2022-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluate the Efficacy and Safety of Various Treatment Schemes for Severe Fever With Thrombocytopenia Syndrome(SFTS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000085142', 'term': 'Severe Fever with Thrombocytopenia Syndrome'}], 'ancestors': [{'id': 'D017282', 'term': 'Tick-Borne Diseases'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D002044', 'term': 'Bunyaviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008775', 'term': 'Methylprednisolone'}, {'id': 'D016756', 'term': 'Immunoglobulins, Intravenous'}, {'id': 'C502936', 'term': 'tocilizumab'}, {'id': 'D006495', 'term': 'Heparin, Low-Molecular-Weight'}], 'ancestors': [{'id': 'D011239', 'term': 'Prednisolone'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D007074', 'term': 'Immunoglobulin G'}, {'id': 'D007132', 'term': 'Immunoglobulin Isotypes'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D006493', 'term': 'Heparin'}, {'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 350}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-08-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-19', 'studyFirstSubmitDate': '2022-10-31', 'studyFirstSubmitQcDate': '2022-10-31', 'lastUpdatePostDateStruct': {'date': '2023-07-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Biomarkers associated with efficacy', 'timeFrame': 'From enrollment to 12 month', 'description': 'Blood, bone marrow, lymph node, urine and stool samples were collected to explore biomarkers associated with predicting the efficacy of methylprednisolone combined with IVIG, tocilizumab and low molecular weight heparin in the treatment of severe fever with thrombocytopenia syndrome.'}], 'primaryOutcomes': [{'measure': '28-day survival rate', 'timeFrame': 'From enrollment to 28 day', 'description': '28-day survival rate was defined as the proportion of patients who were still alive 28 days after enrollment.'}], 'secondaryOutcomes': [{'measure': 'Incidence of complications', 'timeFrame': 'From enrollment to 28 day', 'description': 'The complications include Respiratory system, gastrointestinal system, blood system, nervous system, liver and kidney, lymphatic system, multiple organ dysfunction syndrome may be related to Severe Fever With Thrombocytopenia Syndrome.Incidence of complications was defined as the proportion of complications occur after enrollment.'}, {'measure': 'Incidence of AEs', 'timeFrame': 'From enrollment to 28 day', 'description': "Incidence of adverse events associated with trial drug treatment: blood glucose, electrolyte disturbances, osteoporosis, Cushing's syndrome, double infection, active bleeding, etc."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['interleukin-6', 'D-D dimer', 'efficacy', 'safety', 'severe SFTS'], 'conditions': ['Severe Fever With Thrombocytopenia Syndrome']}, 'descriptionModule': {'briefSummary': 'This is a prospective, multicenter, non-randomized, controlled intervention clinical study.Patients with severe fever with thrombocytopenia syndrome who have been clinically diagnosed and met the study inclusion criteria will be included in the study for analysis.\n\nAll patients with SFTS will be assigned to different groups according to the ratio of 1:3, including the non-intervention group (conventional treatment group) and the related drug intervention group.\n\nNon-intervention group:patients received conventional treatment during hospitalization.\n\nIntervention group:\n\nPart A group: Patients received methylprednisolone 1-2mg/kg/d（or other glucocorticoid equivalent to methylprednisolone 1-2mg/kg/d) + intravenous immunoglobulin (IVIG) 0.2g-0.4g/kg/d for a total of 3-5 days. If the disease progressed after treatment, the patients was given the dose of rescue therapy (methylprednisolone \\> 2mg/kg/d or other glucocorticoid equivalent to methylprednisolone \\> 2mg/kg/d + IVIG 0.4g/kg/d) for another 3-5 days.\n\nPart B group: Patients received tocilizumab 4mg/kg once.\n\nPart C group: Patients received low molecular weight heparin 100U/kg, qd or q12h IH for 4-7 days. If the platelet count is less than 30 × 10\\^9/L, the low molecular weight heparin should be discontinued.\n\nAll patients received conventional treatment. All patients were followed up from the end of treatment to day 28 after completion of treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\. Age ≥18 years. 2. SFTS Patients met the following diagnostic criteria:SFTS-virus (SFTSV) positive in peripheral blood detected by RT-PCR or Next Generation Sequencing (NGS) .\n\n3\\. The intervention group shall meet the following conditions:\n\n1. Part A: Treatment can be initiated if the patient has two of the following conditions: (1) Persistent high fever for 7 days or more; (2) Platelets less than 50×10\\^9/L; (3) Multiple organ function impairment (MODS) including brain, heart, liver, kidney and blood coagulation; (4) Failure of more than 1 organ, such as brain, heart, liver, kidney and coagulation.\n2. Part B: Serum cytokine IL-6 quantification \\>2 times the upper limit of normal (ULN).\n3. Part C: Plasma D-D dimer ≥ 4×ULN. 4. Sign written informed consent and cooperate with follow-up.\n\nExclusion Criteria:\n\n1. Patients with neoplastic diseases.\n2. Patients with severe chronic diseases, such as chronic kidney disease stage 3-5, chronic heart failure, decompensated cirrhosis, chronic diseases of the central nervous system, hematologic neoplastic diseases, uncontrolled solid tumors, etc.\n3. Patients who are or may be pregnant.\n4. Patients with a history of hypersensitivity reaction to the trial drug and its components.\n5. Patients with conditions that the investigator judged to affect short-term survival.\n\nAdditional exclusion criteria for Part B:\n\nPatients with platelet \\< 50×10\\^9/L\n\nAdditional exclusion criteria for Part C:\n\n1. Received vasopressor therapy for more than 36 hours before enrollment;\n2. Indications for anticoagulant therapy (such as ACS, acute VTE, mechanical valve, etc.);\n3. Significant bleeding risk as evidenced by one of the following conditions:\n\n Clinical: Surgery that requires general or spinal anesthesia within 24 hours prior to enrollment, or may require such surgery within the next 24 hours; Evidence of active bleeding; A history of severe head trauma requiring hospitalization; History of intracranial surgery or stroke or any cerebral arteriovenous malformation, cerebral aneurysm, or central nervous system mass within 3 months prior to the study; History of congenital hemorrhage; Gastrointestinal bleeding occurred within 6 weeks before the study unless corrective surgery was performed; Trauma that is thought to increase the risk of bleeding; The presence of an epidural catheter; Laboratory: INR \\> 2.0, or thrombelastogram results suggest significant hyperfibrinolysis.\n4. Present with other forms of shock that are clinically apparent, including cardiogenic, obstructive (massive pulmonary embolism, cardiac tamponade, tension pneumothorax), hemorrhagic, neurogenic, or anaphylactic shock.'}, 'identificationModule': {'nctId': 'NCT05604859', 'briefTitle': 'Evaluate the Efficacy and Safety of Various Treatment Schemes for Severe Fever With Thrombocytopenia Syndrome(SFTS)', 'organization': {'class': 'OTHER', 'fullName': 'Tongji Hospital'}, 'officialTitle': 'Evaluate the Efficacy and Safety of Various Treatment Schemes for Severe Fever With Thrombocytopenia Syndrome：a Prospective, Multicenter, Non-randomized Controlled Intervention Study', 'orgStudyIdInfo': {'id': 'UNBRELLA STUDY'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'non-intervening group', 'description': 'conventional treatment，including symptomatic and supportive treatment, antiviral treatment etc.', 'interventionNames': ['Other: conventional treatment']}, {'type': 'EXPERIMENTAL', 'label': 'intervention group', 'description': 'Part A group: Patients received methylprednisolone 1-2mg/kg/d（or other glucocorticoid equivalent to methylprednisolone 1-2mg/kg/d) + IVIG 0.2g-0.4g/kg/d for a total of 3-5 days. If the disease progressed after treatment, the patients were given the dose of rescue therapy (methylprednisolone \\> 2mg/kg/d or other glucocorticoid equivalent to methylprednisolone \\> 2mg/kg/d + IVIG 0.4g/kg/d) for another 3-5 days.\n\nPart B group: Patients received tocilizumab 4mg/kg once.\n\nPart C group: Patients received low molecular weight heparin 100U/kg, qd or q12h IH for 4-7 days.\n\nAll patients received conventional treatment. All patients were followed up from the end of treatment to day 28 after completion of treatment.', 'interventionNames': ['Drug: Methylprednisolone', 'Drug: intravenous immunoglobulin', 'Drug: Tocilizumab', 'Drug: Low molecular weight heparin', 'Other: conventional treatment']}], 'interventions': [{'name': 'Methylprednisolone', 'type': 'DRUG', 'description': 'Methylprednisolone:1-2mg/kg/d(or other glucocorticoid equivalent to methylprednisolone 1-2mg/kg/d),ivgtt,3-5 days.If disease progression occurs after completion of treatment, the dose of salvage therapy (methylprednisolone \\> 2mg/kg/d or other glucocorticoid equivalent to methylprednisolone \\> 2mg/kg/d) was continued for another 3-5 days.', 'armGroupLabels': ['intervention group']}, {'name': 'intravenous immunoglobulin', 'type': 'DRUG', 'description': 'intravenous immunoglobulin:0.2g-0.4g/kg/d,ivgtt, 3-5 days.If disease progression occurs after completion of treatment, the dose of salvage therapy (IVIG 0.4g/kg/d) was continued for another 3-5 days.', 'armGroupLabels': ['intervention group']}, {'name': 'Tocilizumab', 'type': 'DRUG', 'description': 'Tocilizumab:4mg/kg, once', 'armGroupLabels': ['intervention group']}, {'name': 'Low molecular weight heparin', 'type': 'DRUG', 'description': 'Low molecular weight heparin:100U/kg, qd or q 12h,IH,4-7 days', 'armGroupLabels': ['intervention group']}, {'name': 'conventional treatment', 'type': 'OTHER', 'description': 'conventional treatment，including symptomatic and supportive treatment, antiviral treatment etc.', 'armGroupLabels': ['intervention group', 'non-intervening group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Guangshui', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'qian Liu', 'role': 'CONTACT'}], 'facility': 'Guangshui First Peoples Hospital', 'geoPoint': {'lat': 31.6199, 'lon': 113.9978}}, {'city': 'Huanggang', 'state': 'Hubei', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'guoxiang Zhu', 'role': 'CONTACT'}], 'facility': 'Huanggang Central Hospital', 'geoPoint': {'lat': 30.45143, 'lon': 114.87035}}, {'city': 'Huanggang', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'wei Wang', 'role': 'CONTACT'}], 'facility': 'Luotian County Peoples Hospital', 'geoPoint': {'lat': 30.45143, 'lon': 114.87035}}, {'city': 'Macheng', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'yi Zhou', 'role': 'CONTACT'}], 'facility': 'Macheng Peoples Hospital', 'geoPoint': {'lat': 31.18013, 'lon': 115.02213}}, {'city': 'Qianjiang', 'state': 'Hubei', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'jun Wang', 'role': 'CONTACT'}], 'facility': 'Qianjiang Central Hospital', 'geoPoint': {'lat': 30.421, 'lon': 112.8919}}, {'city': 'Suizhou', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'tiantong Zhou', 'role': 'CONTACT'}], 'facility': 'Suizhou Central Hospital', 'geoPoint': {'lat': 31.71111, 'lon': 113.36306}}, {'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qin Ning, PHD,MD', 'role': 'CONTACT', 'email': 'qning@vip.sina.com', 'phone': '+8602783662391'}, {'name': 'Qin Ning, PHD,MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Tao Chen, PHD,MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Department of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'city': 'Xianning', 'state': 'Hubei', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'jun Zhu', 'role': 'CONTACT'}], 'facility': 'Xianning Central Hospital', 'geoPoint': {'lat': 29.84347, 'lon': 114.32201}}, {'city': 'Yichang', 'state': 'Hubei', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'quan Ming', 'role': 'CONTACT'}], 'facility': 'Yichang Third Peoples Hospital', 'geoPoint': {'lat': 30.71444, 'lon': 111.28472}}, {'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'chuanlong Zhu', 'role': 'CONTACT'}], 'facility': 'Jiangsu Province Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Qin Ning, MD., PhD', 'role': 'CONTACT', 'email': 'qning@vip.sina.com', 'phone': '+8602783662391'}], 'overallOfficials': [{'name': 'Qin Qin, MD., PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Infectious Disease, Tongji Hospital, Tongji Medical College, HUST'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qin Ning', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director and Chair of Department of Infectious Diseases', 'investigatorFullName': 'Qin Ning', 'investigatorAffiliation': 'Tongji Hospital'}}}}