Skip to content

Efficacy of intravenous immunoglobulin (IVIG) in patients with severe epidemic hemorrhagic fever: a multicenter, prospective, randomized controlled study

Efficacy of intravenous immunoglobulin (IVIG) in patients with severe epidemic hemorrhagic fever: a multicenter, prospective, randomized controlled study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200064680
Enrollment
Unknown
Registered
2022-10-14
Start date
2022-10-14
Completion date
Unknown
Last updated
2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Seriously hemorrhagic fever with renal syndromes

Interventions

Part A:IVIG10G/D treatment for 6 days
Part B:IVIG20G/D treatment for 6 days

Sponsors

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age >= 18 years old, regardless of sex; 2. Within 5 days of onset, inpatients diagnosed with epidemic hemorrhagic fever (hemorrhagic fever with renal syndrome) had at least one of the following laboratory results: positive serum specific IgM antibody; or Hantavirus RNA; detected from patient specimens or serum-specific IgG antibody titer in convalescent phase was more than 4 times higher than in acute phase; or Hantavirus was isolated from patient specimens; 3. Meet any of the following criteria: (1) Severe: according to one item, platelet count was 20-50*10^9/L, and white blood cell count was 15-30*10^9/L; (2) Critical illness: platelet count 30*10^9/L; 4. To join this study voluntarily and be able to sign or sign a written informed consent form by a legal representative.

Exclusion criteria

Exclusion criteria: 1. Patients with primary chronic kidney disease; 2. Patients with severe diabetes, hypertension, heart, lung, gastrointestinal tract, liver, autoimmune diseases or nervous system diseases; 3. History of malignant tumors (including solid malignant tumors and hematological malignant tumors); 4. Possible nephrotoxic drugs used in the near future; 5. A patient who is or may be pregnant; 6. Patients with a history of hypersensitivity to IVIG; 7. Selective IgA deficiency patients with IgA antibody; 8. Known or suspected immunodeficiency (HIV infection, primary immunodeficiency), use of immunosuppressive drugs (glucocorticoids); 9. Alcoholism, drug abuse, mental illness; 10. Situations that other researchers consider unsuitable for inclusion.

Design outcomes

Secondary

MeasureTime frame
Incidence of complications;Length of hospitalization;

Primary

MeasureTime frame
Transformation rate;Over stage rate;Case fatality rate;Duration of illness;

Countries

China

Contacts

Public ContactNing Qin

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

qning@vip.sina.com+86 13971521450

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026