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

Primary Purpose

HFRS (Hemorrhagic Fever With Renal Syndrome)

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
IVIG 20g/d
IVIG 10g/d
Sponsored by
Tongji Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HFRS (Hemorrhagic Fever With Renal Syndrome) focused on measuring efficacy, IVIG(intravenous immunoglobulin)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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: 1. 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.

Sites / Locations

  • No.1 Peoples Hospital of GuangshuiRecruiting
  • Huanggang Central HospitalRecruiting
  • People's Hospital of Luotian CountyRecruiting
  • People's Hospital of Macheng City, Affiliated Hospital of Hubei University of Science and TechnologyRecruiting
  • Qianjiang Central HospitalRecruiting
  • Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & TechnologyRecruiting
  • Xianning Central HospitalRecruiting
  • The Third Peoples Hospital of YichangRecruiting
  • Jiangsu Province HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

IVIG 20g/d

IVIG 10g/d

Arm Description

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

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

Outcomes

Primary Outcome Measures

Transformation rate
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
Post-period rate is defined as post-hypotension shock phase or oliguric phase, or post-hypotension shock phase and oliguric phase
Mortality rate
The duration of the disease
The duration of the disease is defined as the duration from symptom onset to recovery and discharge.

Secondary Outcome Measures

The incidence of complications
The incidence of complications is defined as the incidence of shock, renal failure, disseminated intravascular coagulation.
length of hospital stay
The length of hospital stay is defined as the number of days from admission to discharge.

Full Information

First Posted
August 17, 2023
Last Updated
August 22, 2023
Sponsor
Tongji Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06009042
Brief Title
Efficacy of Intravenous Immunoglobulin in Patients With Hemorrhagic Fever With Renal Syndrome: a Prospective Study
Official Title
Efficacy of Intravenous Immunoglobulin in Patients With Hemorrhagic Fever With Renal Syndrome: a Multicenter, Prospective, Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tongji Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HFRS (Hemorrhagic Fever With Renal Syndrome)
Keywords
efficacy, IVIG(intravenous immunoglobulin)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IVIG 20g/d
Arm Type
Experimental
Arm Description
Participants will receive IVIG (intravenous immunoglobulin) 20g/d for 6 days. They also receive conventional liquid therapy and symptomatic supportive treatment.
Arm Title
IVIG 10g/d
Arm Type
Active Comparator
Arm Description
Participants will receive IVIG (intravenous immunoglobulin) 10g/d for 6 days. They also receive conventional liquid therapy and symptomatic supportive treatment.
Intervention Type
Drug
Intervention Name(s)
IVIG 20g/d
Intervention Description
The dose of IVIG(intravenous immunoglobulin) is 20g/d. Participants also receive conventional liquid therapy and symptomatic and supportive treatment.
Intervention Type
Drug
Intervention Name(s)
IVIG 10g/d
Intervention Description
The dose of IVIG(intravenous immunoglobulin) is 10g/d. Participants also receive conventional liquid therapy and symptomatic and supportive treatment.
Primary Outcome Measure Information:
Title
Transformation rate
Description
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].
Time Frame
up to 34th day after treatment
Title
Post-period rate
Description
Post-period rate is defined as post-hypotension shock phase or oliguric phase, or post-hypotension shock phase and oliguric phase
Time Frame
up to 34th day after treatment
Title
Mortality rate
Time Frame
up to 34th day after treatment
Title
The duration of the disease
Description
The duration of the disease is defined as the duration from symptom onset to recovery and discharge.
Time Frame
up to 34th day after treatment
Secondary Outcome Measure Information:
Title
The incidence of complications
Description
The incidence of complications is defined as the incidence of shock, renal failure, disseminated intravascular coagulation.
Time Frame
up to 34th day after treatment
Title
length of hospital stay
Description
The length of hospital stay is defined as the number of days from admission to discharge.
Time Frame
up to 34th day after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 1. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qin Ning, Professor
Phone
+8613971521450
Email
qning@vip.sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qin Ning, Professor
Organizational Affiliation
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
No.1 Peoples Hospital of Guangshui
City
Guangshui
State/Province
Hu Bei Province
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qian Liu
Phone
13872857607
Email
liuqian060685@163.com
Facility Name
Huanggang Central Hospital
City
Huanggang
State/Province
Hu Bei Province
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Huang
Phone
18986552797
Facility Name
People's Hospital of Luotian County
City
Huanggang
State/Province
Hu Bei Province
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Wang
Phone
13409767486
Email
196436547@qq.com
Facility Name
People's Hospital of Macheng City, Affiliated Hospital of Hubei University of Science and Technology
City
Macheng
State/Province
Hu Bei Province
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi Zhou
Phone
19971181214
Email
2513478349@qq.com
Facility Name
Qianjiang Central Hospital
City
Qianjiang
State/Province
Hu Bei Province
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Wang
Phone
13451145526
Email
qjn6249223@163.com
Facility Name
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
City
Wuhan
State/Province
Hu Bei Province
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qin Ning, Professor
Phone
+8613971521450
Email
qning@vip.sina.com
Facility Name
Xianning Central Hospital
City
Xianning
State/Province
Hu Bei Province
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Zhu
Phone
13117160652
Email
1356266581@qq.com
Facility Name
The Third Peoples Hospital of Yichang
City
Yichang
State/Province
Hu Bei Province
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Quan Ming
Phone
13872658268
Email
737695825@qq.com
Facility Name
Jiangsu Province Hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Long Chuan Zhu
Phone
18851729930
Email
18851729930@163.com

12. IPD Sharing Statement

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

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