Evaluate the Efficacy and Safety of Various Treatment Schemes for Severe Fever With Thrombocytopenia Syndrome(SFTS)
NCT ID: NCT05604859
Last Updated: 2023-07-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
350 participants
INTERVENTIONAL
2022-08-19
2024-06-30
Brief Summary
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All 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.
Non-intervention group:patients received conventional treatment during hospitalization.
Intervention group:
Part 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.
Part B group: Patients received tocilizumab 4mg/kg once.
Part 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.
All patients received conventional treatment. All patients were followed up from the end of treatment to day 28 after completion of treatment.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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non-intervening group
conventional treatment，including symptomatic and supportive treatment, antiviral treatment etc.
conventional treatment
conventional treatment，including symptomatic and supportive treatment, antiviral treatment etc.
intervention group
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.
Part B group: Patients received tocilizumab 4mg/kg once.
Part C group: Patients received low molecular weight heparin 100U/kg, qd or q12h IH for 4-7 days.
All patients received conventional treatment. All patients were followed up from the end of treatment to day 28 after completion of treatment.
Methylprednisolone
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.
intravenous immunoglobulin
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.
Tocilizumab
Tocilizumab:4mg/kg, once
Low molecular weight heparin
Low molecular weight heparin:100U/kg, qd or q 12h,IH,4-7 days
conventional treatment
conventional treatment，including symptomatic and supportive treatment, antiviral treatment etc.
Interventions
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Methylprednisolone
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.
intravenous immunoglobulin
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.
Tocilizumab
Tocilizumab:4mg/kg, once
Low molecular weight heparin
Low molecular weight heparin:100U/kg, qd or q 12h,IH,4-7 days
conventional treatment
conventional treatment，including symptomatic and supportive treatment, antiviral treatment etc.
Eligibility Criteria
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Inclusion Criteria
3\. The intervention group shall meet the following conditions:
1. 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.
2. Part B: Serum cytokine IL-6 quantification \>2 times the upper limit of normal (ULN).
3. Part C: Plasma D-D dimer ≥ 4×ULN. 4. Sign written informed consent and cooperate with follow-up.
Exclusion Criteria
2. 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.
3. Patients who are or may be pregnant.
4. Patients with a history of hypersensitivity reaction to the trial drug and its components.
5. Patients with conditions that the investigator judged to affect short-term survival.
Patients with platelet \< 50×10\^9/L
1. Received vasopressor therapy for more than 36 hours before enrollment;
2. Indications for anticoagulant therapy (such as ACS, acute VTE, mechanical valve, etc.);
3. Significant bleeding risk as evidenced by one of the following conditions:
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.
4. 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.
18 Years
ALL
No
Sponsors
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Qin Ning
OTHER
Responsible Party
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Qin Ning
Director and Chair of Department of Infectious Diseases
Principal Investigators
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Qin Qin, MD., PhD
Role: STUDY_CHAIR
Department of Infectious Disease, Tongji Hospital, Tongji Medical College, HUST
Locations
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Guangshui First Peoples Hospital
Guangshui, Hubei, China
Huanggang Central Hospital
Huanggang, Hubei, China
Luotian County Peoples Hospital
Huanggang, Hubei, China
Macheng Peoples Hospital
Macheng, Hubei, China
Qianjiang Central Hospital
Qianjiang, Hubei, China
Suizhou Central Hospital
Suizhou, Hubei, China
Department of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Xianning Central Hospital
Xianning, Hubei, China
Yichang Third Peoples Hospital
Yichang, Hubei, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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qian Liu
Role: primary
guoxiang Zhu
Role: primary
wei Wang
Role: primary
yi Zhou
Role: primary
jun Wang
Role: primary
tiantong Zhou
Role: primary
jun Zhu
Role: primary
quan Ming
Role: primary
chuanlong Zhu
Role: primary
Other Identifiers
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UNBRELLA STUDY
Identifier Type: -
Identifier Source: org_study_id
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