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

NCT05604859 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2023-07-21

No results posted yet for this study

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.

Conditions

  • Severe Fever With Thrombocytopenia Syndrome

Interventions

DRUG

Methylprednisolone

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.

DRUG

intravenous 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.

DRUG

Tocilizumab

Tocilizumab:4mg/kg, once

DRUG

Low molecular weight heparin

Low molecular weight heparin:100U/kg, qd or q 12h,IH,4-7 days

OTHER

conventional treatment

conventional treatment，including symptomatic and supportive treatment, antiviral treatment etc.

Sponsors & Collaborators

  • Qin Ning

    lead OTHER

Principal Investigators

  • Qin Qin, MD., PhD · Department of Infectious Disease, Tongji Hospital, Tongji Medical College, HUST

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05604859 on ClinicalTrials.gov