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

August 22, 2023 updated by: Qin Ning, Tongji Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Hu Bei Province
      • Guangshui, Hu Bei Province, China
        • Recruiting
        • NO.1 Peoples Hospital of Guangshui
        • Contact:
      • Huanggang, Hu Bei Province, China
        • Recruiting
        • Huanggang Central Hospital
        • Contact:
          • Wei Huang
          • Phone Number: 18986552797
      • Huanggang, Hu Bei Province, China
        • Recruiting
        • People's Hospital of Luotian County
        • Contact:
      • Macheng, Hu Bei Province, China
        • Recruiting
        • People's Hospital of Macheng City, Affiliated Hospital of Hubei University of Science and Technology
        • Contact:
      • Qianjiang, Hu Bei Province, China
        • Recruiting
        • Qianjiang Central Hospital
        • Contact:
      • Wuhan, Hu Bei Province, China
        • Recruiting
        • Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
        • Contact:
      • Xianning, Hu Bei Province, China
        • Recruiting
        • Xianning Central Hospital
        • Contact:
      • Yichang, Hu Bei Province, China
        • Recruiting
        • The Third Peoples Hospital of Yichang
        • Contact:
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Recruiting
        • Jiangsu Province Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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:

    1. Positive for serum specific IgM(immunoglobulin M) antibodies;
    2. Or detect hantavirus RNA(ribonucleic acid) from patient specimens;
    3. 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;
    4. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Transformation rate
Time Frame: 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].
up to 34th day after treatment
Post-period rate
Time Frame: 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
up to 34th day after treatment
Mortality rate
Time Frame: up to 34th day after treatment
up to 34th day after treatment
The duration of the disease
Time Frame: up to 34th day after treatment
The duration of the disease is defined as the duration from symptom onset to recovery and discharge.
up to 34th day after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of complications
Time Frame: up to 34th day after treatment
The incidence of complications is defined as the incidence of shock, renal failure, disseminated intravascular coagulation.
up to 34th day after treatment
length of hospital stay
Time Frame: up to 34th day after treatment
The length of hospital stay is defined as the number of days from admission to discharge.
up to 34th day after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tongji Hospital

Investigators

  • Principal Investigator: Qin Ning, Professor, Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2022

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

August 17, 2023

First Submitted That Met QC Criteria

August 22, 2023

First Posted (Actual)

August 24, 2023

Study Record Updates

Last Update Posted (Actual)

August 24, 2023

Last Update Submitted That Met QC Criteria

August 22, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROMISE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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