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A randomized, double-blinded, placebo-controlled, multi-center controlled trial for nebulized recombinant human interferon a2b for the treatment of influenza pneumonia

A randomized, double-blinded, placebo-controlled, multi-center controlled trial for nebulized recombinant human interferon a2b for the treatment of influenza pneumonia

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900022125
Enrollment
Unknown
Registered
2019-03-26
Start date
2016-03-01
Completion date
Unknown
Last updated
2019-04-01

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

Conditions

influenza pneumonia

Interventions

Group 1:basic treatment+Oseltamivir+recombinant human interferon a1b
Group 2:Basic treatment+oseltamivir + inhalation mimetic

Sponsors

Beijing Ditan Hospital Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
14 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Patients of community-acquired pneumoniaage ,14-70. Gender does not limit; 2. Meet the clinical-defined virus pneumonia criteria: 1) fever(oral temperature=38.0 degree C, or axillary temperature =37.4 degree C, or prior history of fever within 48h; 2) with or without dyspenia; 3) Chest radiogram manifestation: unilateral or bilateral chest radiogram test showed multiple (at least two lesions) or diffuse distribution of patchy or glass attenuation infiltrates (with or without consolidation); 3. Etiological examination confirm virus infection exclude influenza virus; 4. Onset time=5d; 5. Patients are able to accept nebulized inhalation treatment; 6. Willing and to be able to provide written informed consent.

Exclusion criteria

Exclusion criteria: 1. Clear laboratory evidence of Streptococcus ,Legionella pneumophila, Mycoplasma, Chlamydia infection, Adenovirus, respiratory syncytial virus, rhinovirus, etc.; 2. Clear laboratory and clinical evidence of bacterial infection. e.g. PCT>1ug/L; 3. Use antiviral drugs within 1 week, and will use anther antiviral drug during the course of the disease; 4. Current or prior hisrtory of critical lung basic diseases: pulmonary tuberculosis, lung cancer, pulmonary edema, atelectasis, pulmonary embolism, pulmonary eosinophilic infiltration and pulmonary vasculitis; 5. Severe hepatic and renal function with significant abnormalities: (1) AST, ALT is over 10 times more than the upper limits of normal; (2) serum creatinine is over 1.5 times more than the upper limits of normal; 6. Particpating another clinical studies within 30 days; 7. Allergic history of interferonor contraindication to interferon: angina, myocardial infarction and other serious cardiovascular disease; history of epilepsy or other central nervous system diseases; obvious abnormal hematopoietic system (platelet <30*10^9/L, the neutral granular cell <0.5*10^9/L); 8. Pregnant or nursing; 9. The survival time maybe less than 48 hours from screening; 10. Those subjects are not suitable for this study by investigator's judgement.

Design outcomes

Primary

MeasureTime frame
Alleviate symptoms of pneumonia;

Secondary

MeasureTime frame
Hospitalization time;Incidence of secondary bacterial pneumonia and antibiotic application;Viral quantity of throat swab;

Countries

China

Contacts

Public ContactJiang Rongmeng

The Center of Infectious Diseases of Beijing Ditan Hospital Capital Medical University

13911900791@163.com+86 010-84322057

Outcome results

None listed

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