Skip to content

Exploration of the Efficacy and Safety of IL-6 Receptor Antagonists in Patients with Severe Influenza

Exploration of the Efficacy and Safety of IL-6 Receptor Antagonists in Patients with Severe Influenza

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500113732
Enrollment
Unknown
Registered
2025-12-02
Start date
2025-12-15
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Severe Influenza

Interventions

Experimental Group:Standard treatment + Tocilizumab (For patients weighing >65 kg and <90 kg: single intravenous injection of 600 mg
For patients weighing <40 kg and <=65 kg: single intravenous injection of 400 mg
For patients weighing <=40 kg: calculate dose at 8 mg/kg for a single intravenous injection)
Control Group:Conventional treatment according to the Influenza Diagnosis and Treatment Guidelines (2025 Edition), including antiviral, supportive, and expectorant therapies, with administration of no

Sponsors

Fengdu General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age 50-80 years, with positive nucleic acid test for influenza A and/or B virus; and CRP>=30 mg/L or IL-6 >=20 pg/mL (see the last paragraph of the "Research Background and Rationale" for supporting evidence); 2. Diagnosed with severe influenza according to the Diagnosis and Treatment Protocol for Influenza (2025 Edition) (meeting any one of the following criteria): (1) Respiratory rate >=30 breaths/min at rest; (2) Oxygen saturation 1,000 meters] using the formula: PaO2/FiO2 × [760/atmospheric pressure (mmHg)], where 1 mmHg = 0.133 kPa); (4) Progressive worsening of clinical symptoms, with lung imaging showing >50% significant lesion progression within 24–48 hours.

Exclusion criteria

Exclusion criteria: 1. Active fungal infection (meeting any one of the following criteria: characteristic findings of fungal infection on CT imaging, or presence of fungi/hyphae in sputum culture or smear); 2. History of allergy to tocilizumab; 3. Confirmed bacterial infection (e.g., sepsis caused by bacterial pathogens, or procalcitonin (PCT) >0.5 ng/mL); 4. Hepatic dysfunction (ALT/AST >2× upper limit of normal) or severe renal impairment (creatinine clearance <=50 mL/min); 5. History of immunosuppressive therapy, active tuberculosis, or concurrent malignancies, diabetes, or active rheumatic/autoimmune diseases; 6. Co-infection with other viral pathogens.

Design outcomes

Primary

MeasureTime frame
Revised Borg Scale;Cough-VAS;

Secondary

MeasureTime frame
Pulmonary function;Oxygenation Index;Length of hospital stay;

Countries

China

Contacts

Public ContactZhang Junguo

Fengdu General Hospital

18723866613@163.com+86 187 2386 6613

Outcome results

None listed

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