drugset / Trial / NCT05604859

Evaluate the Efficacy and Safety of Various Treatment Schemes for Severe Fever With Thrombocytopenia Syndrome(SFTS)

NCT05604859

Phase 4 Unknown 350 enrolled Qin Ning
Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2022-08-19
Primary completion
2023-12-31
Completion
2024-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Heparin Other / unclassified 100 iu/kg
Subject Immune Globulin Intravenous (Human) Protein / enzyme biologic 0.2 g/kg Intravenous
Subject Immune Globulin Intravenous (Human) Protein / enzyme biologic 0.4 g/kg Intravenous
Subject Methylprednisolone Other / unclassified 1 mg/kg Intravenous
Subject Methylprednisolone Other / unclassified 2 mg/kg Intravenous
Subject Tocilizumab Monoclonal antibody 4 mg/kg

Indications

No indication recorded.