Severe Fever With Thrombocytopenia Syndrome
Conditions
Keywords
interleukin-6, D-D dimer, efficacy, safety, severe SFTS
Brief summary
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.
Interventions
DRUGMethylprednisolone
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.
DRUGintravenous 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.
DRUGTocilizumab
Tocilizumab:4mg/kg, once
DRUGLow molecular weight heparin
Low molecular weight heparin:100U/kg, qd or q 12h,IH,4-7 days
OTHERconventional treatment
conventional treatment，including symptomatic and supportive treatment, antiviral treatment etc.
Sponsors
Qin Ning
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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: 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
1. Patients with neoplastic diseases. 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. Additional
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 28-day survival rate | From enrollment to 28 day | 28-day survival rate was defined as the proportion of patients who were still alive 28 days after enrollment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of complications | From enrollment to 28 day | 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. |
| Incidence of AEs | From enrollment to 28 day | Incidence of adverse events associated with trial drug treatment: blood glucose, electrolyte disturbances, osteoporosis, Cushing's syndrome, double infection, active bleeding, etc. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Biomarkers associated with efficacy | From enrollment to 12 month | 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. |
Countries
China
Contacts
Primary ContactQin Ning, MD., PhD
Outcome results
None listed