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A Randomized Controlled Trial of Different Doses of Intravenous Immunoglobulin in the Treatment of Severe Fever with Thrombocytopenia Syndrome

A Randomized Controlled Trial of Different Doses of Intravenous Immunoglobulin in the Treatment of Severe Fever with Thrombocytopenia Syndrome

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600128408
Enrollment
Unknown
Registered
2026-07-20
Start date
2026-08-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe Fever with Thrombocytopenia Syndrome (SFTS)

Interventions

Standard-dose IVIG group (SOC + IVIG 20g/d):Standardized symptomatic and supportive treatment for severe SFTS plus standard-dose IVIG
Low-dose IVIG group (SOC + IVIG 10g/d):Standardized symptomatic and supportive treatment for severe SFTS combined with low-dose IVIG
Control group (SOC + Placebo):Standardized symptomatic and supportive treatment for severe SFTS plus normal saline placebo

Sponsors

The first affiliated hospital of anhui medical university
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged between 18 and 75 years old with no gender restriction; 2. Confirmed diagnosis of SFTS, disease course no more than 7 days, and positive SFTSV RNA test result; 3. Severe case criteria: platelet count less than 50×10?/L accompanied by organ damage or disturbance of consciousness; 4. Voluntarily sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Severe liver and kidney failure, malignant tumors, autoimmune diseases and severe infections; 2. Previous use of IVIG, immunosuppressive or immunostimulant drugs; 3. Pregnant or lactating women; 4. Allergy to IVIG or its excipients; 5. Failure to cooperate with follow-up visits or incomplete medical data.

Design outcomes

Primary

MeasureTime frame
28-day case fatality rate;Incidence rate of adverse events;

Secondary

MeasureTime frame
Levels of IL-6 and IFN-?;SFTSV viral load;Platelet recovery time;

Countries

China

Contacts

Public ContactHu Lifen

The first affiliated hospital of anhui medical university

lifen.hu@163.com+86 551 6292 2713

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 10, 2026