Skip to content

A multi-center clinical study to evaluate the effectiveness and safety of favipiravir against novel Bunya virus

A multi-center clinical study to evaluate the effectiveness and safety of favipiravir in treatment of Severe fever with thrombocytopenia syndrome (SFTS)

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000040089
Enrollment
Unknown
Registered
2020-11-20
Start date
2020-11-10
Completion date
Unknown
Last updated
2021-01-05

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

Conditions

Novel Bunya virus infection

Interventions

control group:Follow the guidelines for symptomatic support treatment
experimental group:symptomatic treatment+Favipiravir

Sponsors

The First Affiliated Hospital of Anhui Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed in accordance with the prevention and treatment guidelines of Severe fever with thrombocytopenia syndrome (SFTS) issued by the Ministry of Health; 2. platelet count between (30~80)x10^9/L on admission; 3. aged between 18 to 80 years; 4. women of childbearing age or male subjects agree to take Take effective contraceptive measures within 90 days after the last admission of oral medicine to ensure the female subjects or male subjects partners are not pregnant; 5. subjects are willing to participate in the study and accept the randomization; 6. Not participated in any drug clinical trials before signing the written informed consent.

Exclusion criteria

Exclusion criteria: 1. judged by the investigator to be unsuitable to participate in this studye.g. Severe vomiting or difficulty taking medication; 2. The time interval between admission time and onset time was >7 days; 3. with hyperchloremic acidosis renal insufficiencyanuria or any other contraindications; 4. received systematic antiviral and immunoregulatory therapy 6 months before this study; 5. Co-infection with other pathogens, such as HBV, HCV, HIV or syphilis, or pathogens that cause similar symptoms, such as rickettsia, Lyme disease spirochetes or Babesia; 6. Patients with chronic underlying diseases such as cancer, tuberculosis or nephropathy; 7. Have recently taken antiplatelet drugs or antiallergic drugs; 8. pregnant or lactating women; 9. Patients participating in other clinical trials.

Design outcomes

Primary

MeasureTime frame
fatality rate;rate of severity;improvement rate;Virus clearance rate;

Secondary

MeasureTime frame
Disappearance time of major clinical features;Days of Restoration of Thrombocyte and leucocyte;Incidence of severe complications;hemorrhage;immunological index;

Countries

China

Contacts

Public ContactXihai XU

The First Affiliated Hospital of Anhui Medical University

2xhai@163.com+86 13966658330

Outcome results

None listed

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