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A randomized, double-blinded, placebo-controlled, multi-center clinical study of nebulized recombinant human interferon a1b for the treatment of viral pneumonia without influenza

A randomized, double-blinded, placebo-controlled, multi-center clinical study of nebulized recombinant human interferon a1b for the treatment of viral pneumonia without influenza

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-INR-16007772
Enrollment
Unknown
Registered
2016-01-08
Start date
2016-01-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

viral pneumonia without influenza

Interventions

Treatment Group:Conventional treatment + nebulized IFN-a1b
Control group:Conventional treatment + nebulized placebo

Sponsors

Beijing Ditan Hospital Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
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?, or axillary temperature =37.4?, 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 able to provide written informed consent

Exclusion criteria

Exclusion criteria: 1. Clear laboratory evidence of Streptococcus ,Legionella pneumophila, Mycoplasma and Chlamydia infection; 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. Patients of sever pneumonia; 5. Current or prior hisrtory of critical lung basic diseases: pulmonary tuberculosis, lung cancer, pulmonary edema, atelectasis, pulmonary embolism, pulmonary eosinophilic infiltration and pulmonary vasculitis; 6. 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; 7. Particpating another clinical studies within 30 days; 8. 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); 9. Pregnant or nursing; 10. The survival time maybe less than 48 hours from screening; 11. 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 ContactLi Xing Wang
ditanlxw@163.com+86 10-84322585

Outcome results

None listed

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