Testing the effectiveness of intravenous immunoglobulin for severe hemorrhagic fever with renal syndrome

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

This study is testing if different doses of a treatment called intravenous immunoglobulin can help people with severe hemorrhagic fever with renal syndrome get better faster and reduce their hospital stay.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Tongji Hospital (other)
• Locations: 9 sites (Guangshui, Hu Bei Province and 8 other locations)
• Trial ID: NCT06009042 on ClinicalTrials.gov

What this trial studies

This multicenter, prospective, randomized controlled study aims to evaluate the efficacy of different doses of intravenous immunoglobulin (IVIG) in treating patients with severe hemorrhagic fever with renal syndrome (HFRS). Approximately 100 hospitalized patients diagnosed with severe HFRS will be randomly assigned to receive either 10g/d or 20g/d of IVIG for six days, alongside routine supportive treatments. The study will collect various clinical and laboratory data to assess treatment outcomes, including transformation rates, mortality rates, and length of hospital stay.

Who should consider this trial

Good fit: Ideal candidates for this study are hospitalized adults aged 18 and older diagnosed with severe or critically ill HFRS within five days of symptom onset.

Not a fit: Patients with mild HFRS or those who do not meet the specific laboratory criteria for severe illness may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients suffering from severe HFRS.

How similar studies have performed: While there have been studies on IVIG for various conditions, this specific approach for severe HFRS is novel and has not been extensively tested.

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:

  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.

Where this trial is running

Guangshui, Hu Bei Province and 8 other locations

• No.1 Peoples Hospital of Guangshui — Guangshui, Hu Bei Province, China (RECRUITING)
• Huanggang Central Hospital — Huanggang, Hu Bei Province, China (RECRUITING)
• People's Hospital of Luotian County — Huanggang, Hu Bei Province, China (RECRUITING)
• People's Hospital of Macheng City, Affiliated Hospital of Hubei University of Science and Technology — Macheng, Hu Bei Province, China (RECRUITING)
• Qianjiang Central Hospital — Qianjiang, Hu Bei Province, China (RECRUITING)
• Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology — Wuhan, Hu Bei Province, China (RECRUITING)
• Xianning Central Hospital — Xianning, Hu Bei Province, China (RECRUITING)
• The Third Peoples Hospital of Yichang — Yichang, Hu Bei Province, China (RECRUITING)
• Jiangsu Province Hospital — Nanjing, Jiangsu, China (RECRUITING)

Study contacts

• Principal investigator: Qin Ning, Professor — Tongji Hospital
• Study coordinator: Qin Ning, Professor

Conditions: HFRS, efficacy, IVIG（intravenous immunoglobulin）