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A multicenter, randomized, open, parallel, prospective controlled trial for ribavirin in antiviral therapy for hemorrhagic fever with renal syndrome

A multicenter, randomized, open, parallel, prospective controlled trial for ribavirin in antiviral therapy for hemorrhagic fever with renal syndrome

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000034218
Enrollment
Unknown
Registered
2020-06-28
Start date
2020-07-01
Completion date
Unknown
Last updated
2020-06-29

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

Conditions

Hemorrhagic fever with renal syndrome, HFRS

Interventions

Ribavirin treatment group:Ribavirin and conventional therapy
Conventional treatment group:Conventional treatment

Sponsors

Department of Infectious Diseases, The Second Affiliated Hospital of Air Force Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Patients within 6 days of onset and in the fever period (including fever, hypotension two-stage overlap, or fever, hypotension, oliguria three-stage overlap); 2. Patients aged 18 to 70 years; 3. Patients with HFRS case definition or serological confirmation; 4. Patients with Hgb >=100g/L and no history of ribavirin allergy; 5. Patients who agree to use ribavirin, collect specimens, report adverse events and follow up as required (28-30 days after discharge); 6. Objects without family planning within half a year; 7. Patients without history of chronic pancreatitis.

Exclusion criteria

Exclusion criteria: 1. Patients who have been sick for more than 7 days, have no fever at the time of admission, or have entered the stage of oliguria, transition and polyuria; 2. Patients with a history of allergy or other adverse reactions to ribavirin; 3. Patients with HGB 400u / L; 7. Patients with history of hemolytic anemia or T-Bil >3 ULN or i-bil >3 ULN.

Design outcomes

Primary

MeasureTime frame
Serum hantavirus load;

Secondary

MeasureTime frame
platelet count;Aspartate aminotransferase, AST;APTT;fibrinogen, Fib;creatinine, Cr;blood urea nitrogen, BUN;eGFR;IL-6;procalcitonin, PCT;urine volume;oliguria stage;

Countries

China

Contacts

Public ContactLian Jianqi

The Second Affiliated Hospital of Air Force Medical University

lianjq@fmmu.edu.cn+86 13571892829

Outcome results

None listed

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