Evaluating treatments for Severe Fever With Thrombocytopenia Syndrome

Evaluate the Efficacy and Safety of Various Treatment Schemes for Severe Fever With Thrombocytopenia Syndrome：a Prospective, Multicenter, Non-randomized Controlled Intervention Study

This study is testing different treatment options for people with Severe Fever With Thrombocytopenia Syndrome to see which ones work best and are safe.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 350 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Tongji Hospital (Academic / other)
• Drugs / interventions: tocilizumab
• Locations: 10 sites (Guangshui, Hubei and 9 other locations)
• Trial ID: NCT05604859 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the efficacy and safety of various treatment schemes for patients diagnosed with Severe Fever With Thrombocytopenia Syndrome (SFTS). It is a multicenter, non-randomized, controlled intervention study where patients will be assigned to either a non-intervention group receiving conventional treatment or an intervention group receiving a combination of methylprednisolone and intravenous immunoglobulin, among other treatments. The study will analyze the outcomes based on the severity of the condition and the response to the treatments administered.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older who have been clinically diagnosed with SFTS and meet specific inclusion criteria.

Not a fit: Patients with neoplastic diseases or severe chronic conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide effective treatment options for patients suffering from Severe Fever With Thrombocytopenia Syndrome.

How similar studies have performed: While there may be limited data on similar approaches, the study's focus on established treatments suggests potential for success based on previous interventions for severe viral infections.

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.

Where this trial is running

Guangshui, Hubei and 9 other locations

• Guangshui First Peoples Hospital — Guangshui, Hubei, China (Recruiting)
• Huanggang Central Hospital — Huanggang, Hubei, China (Not_yet_recruiting)
• Luotian County Peoples Hospital — Huanggang, Hubei, China (Recruiting)
• Macheng Peoples Hospital — Macheng, Hubei, China (Recruiting)
• Qianjiang Central Hospital — Qianjiang, Hubei, China (Not_yet_recruiting)
• Suizhou Central Hospital — Suizhou, Hubei, China (Recruiting)
• Department of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)
• Xianning Central Hospital — Xianning, Hubei, China (Not_yet_recruiting)
• Yichang Third Peoples Hospital — Yichang, Hubei, China (Not_yet_recruiting)
• Jiangsu Province Hospital — Nanjing, Jiangsu, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Qin Ning, MD., PhD

Conditions Severe Fever With Thrombocytopenia Syndrome; interleukin-6; D-D dimer; efficacy; safety; severe SFTS