severe fever with thrombocytopenia syndrome
Conditions
Interventions
Test group:Administer alfacalcidol to the patient orally.
Control group:Administer the placebo orally.
Sponsors
Beijing Ditan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 74 Years
Inclusion criteria
Inclusion criteria: 1.The patient's age should be 18 years or older and less than 75 years. 2.According to the Diagnosis and Treatment Plan for Severe Fever with Thrombocytopenia Syndrome (2023 Edition), the patients can be diagnosed as having mild, moderate or severe cases of SFTS. 3.At the time of enrollment, the onset time of the patients should be within 5 days (the onset time will be calculated based on the date when the first SFTS-related symptom occurres as the starting point). 4.The patient himself/herself or the legal representative fully understands the purpose and content of the study, voluntarily signs the written informed consent form, and agrees to follow the research protocol to complete the prescribed treatment and follow-up.
Exclusion criteria
Exclusion criteria: 1.According to the Diagnosis and Treatment Plan for Severe Fever with Thrombocytopenia Syndrome (2023 Edition), the patients can be diagnosed as having critical cases of SFTS. 2.The patient has other infectious diseases, including other infections that can cause similar symptoms of fever and bleeding, active tuberculosis, active hepatitis, HIV infection, and other infectious diseases that may affect the immune function. 3.The patient has severe underlying diseases, including malignant tumors, end-stage liver disease (Child-Pugh C grade), end-stage kidney disease (requiring dialysis treatment), and heart failure (NYHA grade III or above). 4.The patient has contraindications for the use of alfacalcidol, including hypercalcemia (serum calcium > 2.60 mmol/L or ionized calcium > 1.30 mmol/L), hyperphosphatemia (serum phosphorus > 1.45 mmol/L), and a history of allergy to vitamin D preparations such as alfacalcidol. 5.The patient had used vitamin D or its derivatives for treatment within 30 days prior to admission, or had received treatment with other drugs that might interfere with this study. 6.The patient had received a systematic course of antiviral and immunomodulatory treatment (such as a history of using ribavirin or favipiravir) within 30 days prior to admission. 7.The patient is a woman who is pregnant or breastfeeding. 8.Other factors: The researchers believe that the subjects had poor compliance and were unable to fulfill the requirements of the study, or the subjects had already participated in other interventional clinical studies and the studies were not yet completed.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 28-day rate of progression to severe disease;28-day mortality rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| ICU admission rate;Incidence rate of adverse events;Change in SFTSV viral load at day 8;Changes in key blood biochemical parameters at Day 8;Incidence of serious adverse events; | — |
Countries
China
Contacts
Public ContactZhihai Chen
Beijing Ditan Hospital, Capital Medical University
Outcome results
None listed