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Study on the treatment of Severe Fever with Thrombocytopenia Syndrome with Faviravir Tablets

Favipiravir Tablets in the Treatment of Severe Fever with Thrombocytopenia Syndrome (SFTS): A Multicenter, Prospective, Double-Blind, Randomized Controlled Study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500104487
Enrollment
Unknown
Registered
2025-06-18
Start date
2025-08-01
Completion date
Unknown
Last updated
2025-06-24

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

Interventions

Placebo group:Favipiravir tablet matching placebo
Experimental group:Favipiravir tablet (investigational product)

Sponsors

The Second Hospital of Anhui Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1 .The participant or their legally authorized representative voluntarily provided written informed consent; 2. 18 years or older; 3. Suspected or confirmed severe fever with thrombocytopenia syndrome; 4. Symptom onset (fever) to hospital admission within 7 days; 5. Women of childbearing potential must agree to use highly effective contraception for 3 months after the first dose.

Exclusion criteria

Exclusion criteria: 1. Patients with severe comorbidities that significantly impair immune function or general health status, including uncontrolled cardiovascular, cerebrovascular, hepatic, renal, or hematopoietic system diseases, uncontrolled malignancies, or psychiatric disorders; 2. Patients with a history of gout, serum uric acid >540 µmol/L, or hypersensitivity to any component of the investigational product; 3. Participation in any other clinical trial within the past 3 months; 4. Patients unable to swallow oral medications; 5. Pregnant or breastfeeding women, or women planning pregnancy during the study period; 6. Any other condition deemed unsuitable for participation by the investigator;

Design outcomes

Primary

MeasureTime frame
DBV nucleic acid;

Secondary

MeasureTime frame
ICU occupancy rate;case fatality rate;Severe incidence rate;

Countries

China

Contacts

Public ContactZhenhua Zhang

The Second Hospital of Anhui Medical University

zzh1974cn@163.com+86 551 65997112

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026