SFTS
Conditions
Interventions
Placebo group:Placebo (normal saline) plus guideline-based supportive care, administered at the same dose and frequency as Nb120 antibody.
Antibody treatment group:Nb120 antibody plus guideline-based supportive care
Sponsors
The Second Hospital of Nanjing
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: All subjects must meet the following criteria to be eligible for inclusion in the trial: 1. Aged 18–65 years, regardless of gender; 2. Diagnosed with SFTSV infection based on the 2023 National Health Commission's "Diagnosis and Treatment Protocol for Fever with Thrombocytopenia Syndrome", meeting any one of the following criteria: (1) SFTSV nucleic acid positive (viral load >10 TCID50/mL); (2) SFTSV cultured and isolated from clinical specimens; (3) SFTSV-IgG seroconversion or a fourfold or greater increase in antibody titre between acute and convalescent phases. 3. Able to communicate effectively with the investigator, voluntarily participate in the trial after understanding its content and potential risks, and sign an ethics committee-approved informed consent form prior to undergoing any trial-related procedures.
Exclusion criteria
Exclusion criteria: Subjects meeting any of the following criteria shall be excluded from this study: 1. Presence of underlying unstable medical conditions, with persistent fever ranging from 39.0°C to 40.0°C or higher, apathy, cutaneous ecchymoses, and possible involuntary movements in the jaw or limbs accompanied by increased muscle tone, along with neurological symptoms such as somnolence, confusion, or stupor; concurrent pulmonary infection, or bleeding from the gastrointestinal tract, lungs, uterus, or other sites; Significant neurological symptoms such as coma, delirium, or recurrent seizures; shock; or concomitant organ failure requiring intensive care unit (ICU) monitoring and treatment; 2. History of substance abuse or drug use; 3. Psychiatric disorders or other conditions precluding comprehension of the study protocol or signing of the informed consent form; 4. Other circumstances deemed by the investigator to render the subject unsuitable for trial participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of severe disease; | — |
Secondary
| Measure | Time frame |
|---|---|
| Case fatality rate;Time to viral suppression;Viral loads;Platelet count and white blood cell (WBC) count;Safety-related outcomes; | — |
Countries
China
Contacts
Public ContactHongxia Wei
The Second Hospital of Nanjing
Outcome results
None listed