NCT06009042

Efficacy of Intravenous Immunoglobulin in Patients With Hemorrhagic Fever With Renal Syndrome: a Prospective Study

Efficacy of Intravenous Immunoglobulin in Patients With Hemorrhagic Fever With Renal Syndrome: a Multicenter, Prospective, Randomized Controlled Study

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Tongji Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this randomized study to test the efficacy of different doses of IVIG (intravenous immunoglobulin) in the treatment of severe HFRS（hemorrhagic fever with renal syndrome）, and provide new clinical ideas for the treatment and prognosis of HFRS patients in the future. This study will include all hospitalized patients with confirmed severe or critically ill HFRS from October 2021 to October 2023 from 9 centers. Participants will receive IVIG 10g/d or IVIG 20g/d. All the participants will be given conventional liquid therapy and symptomatic and supportive treatment. Participants will be collected demographic, epidemiological history, hospitalization information, clinical data, laboratory data, imaging results, treatment regimens, and outcomes data.

Detailed description

This is a multicenter, prospective, randomized controlled study which aims at evaluating the efficacy of different doses of IVIG (intravenous immunoglobulin) in the treatment of patients with severe HFRS(hemorrhagic fever with renal syndrome), and providing reference for the future application of IVIG in severe hemorrhagic fever with renal syndrome. This study will include approximately 100 patients with severe hemorrhagic fever with renal syndrome who are randomly assigned to either the IVIG 10g/d group or the IVIG 20g/d group in a 1:1 ratio. The participants in each group will receive treatments for 6 days. Both groups are given routine liquid therapy and symptomatic supportive treatment. The main endpoints include transformation rate, post-period rate, mortality rate, and duration of the disease. Secondary endpoints include the incidence of complications and length of hospital stay.

Conditions

• HFRS (Hemorrhagic Fever With Renal Syndrome)

Interventions

Type	Name	Description
DRUG	IVIG 20g/d	The dose of IVIG(intravenous immunoglobulin) is 20g/d. Participants also receive conventional liquid therapy and symptomatic and supportive treatment.
DRUG	IVIG 10g/d	The dose of IVIG(intravenous immunoglobulin) is 10g/d. Participants also receive conventional liquid therapy and symptomatic and supportive treatment.

Timeline

• Start date: 2022-07-01
• Primary completion: 2024-06-30
• Completion: 2024-06-30
• First posted: 2023-08-24
• Last updated: 2023-08-24

Locations

9 sites across 1 country: China