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

Sponsor

Tongji Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT06009042

Collaborator

(none)

100

Enrollment

Locations

Arms

Anticipated Duration (Months)

11.1

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
HFRS (Hemorrhagic Fever With Renal Syndrome)	Drug: IVIG 20g/d Drug: IVIG 10g/d	Phase 4

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

Jun 30, 2024

Anticipated Study Completion Date :

Jun 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: IVIG 20g/d Participants will receive IVIG (intravenous immunoglobulin) 20g/d for 6 days. They also receive conventional liquid therapy and symptomatic supportive treatment.	Drug: IVIG 20g/d The dose of IVIG(intravenous immunoglobulin) is 20g/d. Participants also receive conventional liquid therapy and symptomatic and supportive treatment.
Active Comparator: IVIG 10g/d Participants will receive IVIG (intravenous immunoglobulin) 10g/d for 6 days. They also receive conventional liquid therapy and symptomatic 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.

Arm

Intervention/Treatment

Experimental: IVIG 20g/d

Participants will receive IVIG (intravenous immunoglobulin) 20g/d for 6 days. They also receive conventional liquid therapy and symptomatic supportive treatment.

Drug: IVIG 20g/d

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

Active Comparator: IVIG 10g/d

Participants will receive IVIG (intravenous immunoglobulin) 10g/d for 6 days. They also receive conventional liquid therapy and symptomatic 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.

Outcome Measures

Primary Outcome Measures

Transformation rate [up to 34th day after treatment]
The transformation rate is defined as the rate of transformation [critical to severe, moderate or mild, severe to moderate or mild], or the rate of transition [severe to critical].
Post-period rate [up to 34th day after treatment]
Post-period rate is defined as post-hypotension shock phase or oliguric phase, or post-hypotension shock phase and oliguric phase
Mortality rate [up to 34th day after treatment]
The duration of the disease [up to 34th day after treatment]
The duration of the disease is defined as the duration from symptom onset to recovery and discharge.

Secondary Outcome Measures

The incidence of complications [up to 34th day after treatment]
The incidence of complications is defined as the incidence of shock, renal failure, disseminated intravascular coagulation.
length of hospital stay [up to 34th day after treatment]
The length of hospital stay is defined as the number of days from admission to discharge.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

The patients must meet all of the following criteria:

Age ≥ 18 years, regardless of gender;
Within 5 days of onset, hospitalized patients diagnosed with epidemic hemorrhagic fever (hemorrhagic fever with renal syndrome) must have at least one of the following laboratory test results:

Positive for serum specific IgM(immunoglobulin M) antibodies;
Or detect hantavirus RNA(ribonucleic acid) from patient specimens;
Or the serum specific IgG(immunoglobulin G) antibody titer in the recovery phase is more than four times higher than that in the acute phase;
Or hantavirus can be isolated from patient specimens.

Meet any of the following criteria:

Severe illness: meet any of the following criteria: (i) Platelet count 20-50×10^{9/L; (ii) White blood cell count 15-30×10}9/L. 2. Critical illness: meet any of the following criteria: (i) Platelet count<20×10^{9/L; (ii) White blood cell
count>30×10}9/L.

Volunteer to join this study and be able to sign or have a written informed consent form signed by a legal representative.

Exclusion Criteria:

Exclude patients who meet any of the following criteria:

Patients with primary chronic kidney disease;
Patients with severe diabetes, hypertension, heart, lung, gastrointestinal tract, liver, autoimmune disease or nervous system disease;
Have a history of malignant tumors (including solid malignant tumors and hematological malignancies etc.);
Recent use of potentially nephrotoxic drugs;
Pregnant or potentially pregnant patients;
Patients with a history of hypersensitivity to IVIG (intravenous immunoglobulin) ;
Selective IgA(immunoglobulin A) deficiency patients with IgA antibodies;
Known or suspected immunodeficiency (human immunodeficiency virus infection, primary immunodeficiency), use of immunosuppressive drugs (glucocorticoids);
Alcoholics, drug abuse, and psychiatric patients
Other conditions which researchers deem not suitable for inclusion.

Contacts and Locations

Locations

	Site	City	State	Country
1	No.1 Peoples Hospital of Guangshui	Guangshui	Hu Bei Province	China
2	Huanggang Central Hospital	Huanggang	Hu Bei Province	China
3	People's Hospital of Luotian County	Huanggang	Hu Bei Province	China
4	People's Hospital of Macheng City, Affiliated Hospital of Hubei University of Science and Technology	Macheng	Hu Bei Province	China
5	Qianjiang Central Hospital	Qianjiang	Hu Bei Province	China
6	Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology	Wuhan	Hu Bei Province	China
7	Xianning Central Hospital	Xianning	Hu Bei Province	China
8	The Third Peoples Hospital of Yichang	Yichang	Hu Bei Province	China
9	Jiangsu Province Hospital	Nanjing	Jiangsu	China