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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| non-intervening group | Active Comparator | conventional treatment,including symptomatic and supportive treatment, antiviral treatment etc. |
|
| intervention group | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylprednisolone | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 28-day survival rate | 28-day survival rate was defined as the proportion of patients who were still alive 28 days after enrollment. | From enrollment to 28 day |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of complications | 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. | From enrollment to 28 day |
| Measure | Description | Time Frame |
|---|---|---|
| Biomarkers associated with efficacy | 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. | From enrollment to 12 month |
Inclusion Criteria:
1. 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) .
3. The intervention group shall meet the following conditions:
Exclusion Criteria:
Additional exclusion criteria for Part B:
Patients with platelet < 50×10^9/L
Additional exclusion criteria for Part C:
Received vasopressor therapy for more than 36 hours before enrollment;
Indications for anticoagulant therapy (such as ACS, acute VTE, mechanical valve, etc.);
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.
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qin Ning, MD., PhD | Contact | +8602783662391 | qning@vip.sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Qin Qin, MD., PhD | Department of Infectious Disease, Tongji Hospital, Tongji Medical College, HUST | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangshui First Peoples Hospital | Recruiting | Guangshui | Hubei | China |
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|
| intravenous immunoglobulin | Drug | 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 | Drug | Tocilizumab:4mg/kg, once |
|
| Low molecular weight heparin | Drug | Low molecular weight heparin:100U/kg, qd or q 12h,IH,4-7 days |
|
| conventional treatment | Other | conventional treatment,including symptomatic and supportive treatment, antiviral treatment etc. |
|
| Incidence of AEs | Incidence of adverse events associated with trial drug treatment: blood glucose, electrolyte disturbances, osteoporosis, Cushing's syndrome, double infection, active bleeding, etc. | From enrollment to 28 day |
| Huanggang Central Hospital | Not yet recruiting | Huanggang | Hubei | China |
|
| Luotian County Peoples Hospital | Recruiting | Huanggang | Hubei | China |
|
| Macheng Peoples Hospital | Recruiting | Macheng | Hubei | China |
|
| Qianjiang Central Hospital | Not yet recruiting | Qianjiang | Hubei | China |
|
| Suizhou Central Hospital | Recruiting | Suizhou | Hubei | China |
|
| Department of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology | Recruiting | Wuhan | Hubei | China |
|
| Xianning Central Hospital | Not yet recruiting | Xianning | Hubei | China |
|
| Yichang Third Peoples Hospital | Not yet recruiting | Yichang | Hubei | China |
|
| Jiangsu Province Hospital | Not yet recruiting | Nanjing | Jiangsu | China |
|
| ID | Term |
|---|---|
| D000085142 | Severe Fever with Thrombocytopenia Syndrome |
| ID | Term |
|---|---|
| D017282 | Tick-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| D007239 | Infections |
| D002044 | Bunyaviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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| ID | Term |
|---|---|
| D008775 | Methylprednisolone |
| D016756 | Immunoglobulins, Intravenous |
| C502936 | tocilizumab |
| D006495 | Heparin, Low-Molecular-Weight |
| ID | Term |
|---|---|
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D007074 | Immunoglobulin G |
| D007132 | Immunoglobulin Isotypes |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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