Clinical trial NCT05604859: Evaluate the Efficacy and Safety of Various Treatment Schemes for Severe Fever With Thrombocytopenia Syndrome(SFTS)
Official title: Evaluate the Efficacy and Safety of Various Treatment Schemes for Severe Fever With Thrombocytopenia Syndrome：a Prospective, Multicenter, Non-randomized Controlled Intervention Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Severe Fever With Thrombocytopenia Syndrome
Keywords: interleukin-6
D-D dimer
efficacy
safety
severe SFTS
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2022-11-03
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 exclusion criteria for Part B:

Patients with platelet \< 50×10\^9/L

Additional exclusion criteria for Part C:

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.

Primary outcomes:
measure: 28-day survival rate
timeFrame: From enrollment to 28 day
Secondary outcomes:
measure: Incidence of complications
timeFrame: From enrollment to 28 day
measure: Incidence of AEs
timeFrame: From enrollment to 28 day
Other outcomes:
measure: Biomarkers associated with efficacy
timeFrame: From enrollment to 12 month
Locations:
city: Guangshui
country: China
facility: Guangshui First Peoples Hospital
state: Hubei
city: Huanggang
country: China
facility: Huanggang Central Hospital
state: Hubei
city: Huanggang
country: China
facility: Luotian County Peoples Hospital
state: Hubei
city: Macheng
country: China
facility: Macheng Peoples Hospital
state: Hubei
city: Qianjiang
country: China
facility: Qianjiang Central Hospital
state: Hubei
city: Suizhou
country: China
facility: Suizhou Central Hospital
state: Hubei
city: Wuhan
country: China
facility: Department of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Xianning
country: China
facility: Xianning Central Hospital
state: Hubei
city: Yichang
country: China
facility: Yichang Third Peoples Hospital
state: Hubei
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
Study officials:
affiliation: Department of Infectious Disease, Tongji Hospital, Tongji Medical College, HUST
name: Qin Qin, MD., PhD
role: STUDY_CHAIR
References: