Dataset Information

Efficacy and safety of aerosol inhalation of recombinant human interferon ?1b (IFN?1b) injection for noninfluenza viral pneumonia, a multicenter, randomized, double-blind, placebo-controlled trial.

ABSTRACT: Background:To investigate the efficacy and safety of aerosol inhalation of recombinant human interferon ?1b (IFN?1b) injection for noninfluenza viral pneumonia. Methods:One hundred sixty-four patients with noninfluenza viral pneumonia were divided into IFN?1b and control groups. The IFN?1b group received routine treatment + aerosol inhalation of recombinant human IFN?1b injection (50??g?×?2 injections, bid). The control group received routine treatment + IFN analog (two injections, bid). Overall response rate (ORR) of five kinds clinical symptoms. Further outcomes were daily average score and the response rate of each of the symptoms above. Results:A total of 163 patients were included in the full analysis set (FAS) and 151 patients were included in the per-protocol set (PPS). After 7?days of treatment, ORR of clinical symptoms was higher in IFN?1b group than that in control group for both the FAS and PPS. Moreover, after 7?days of treatment, the daily score of three efficacy indexes including expectoration, respiratory rate, and pulmonary rales were improved. The ORRs for expectoration and pulmonary rales were higher in the IFN?1b group than in the control group (P??0.05). The incidence of adverse events was 6.5% (n?=?5) in IFN?1b group and 3.5% (n?=?3) in control group (P?>?0.05). Conclusion:Aerosol inhalation of recombinant human IFN?1b is safe and it can improve the clinical symptoms of noninfluenza viral pneumonia.

SUBMITTER: Jiang R

PROVIDER: S-EPMC7221328 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Efficacy and safety of aerosol inhalation of recombinant human interferon α1b (IFNα1b) injection for noninfluenza viral pneumonia, a multicenter, randomized, double-blind, placebo-controlled trial.

Jiang Rongmeng R Han Bing B Song Meihua M Xue Bing B Zhang Yongxiang Y Ding Yanyan Y Chen Jin J Zhu Jing J Liu Jianhua J Nie Qingrong Q Han Xuefeng X Jin Xiuhong X Shan Xiaoyin X Guo Weian W Zhang Erming E Zhang Zuoqing Z Zhang Changhong C Zhang Jie J Wang Baozeng B Dong Shuwen S Li Jiandong J Li Xiaoguang X Li Xingwang X

Journal of inflammation (London, England) 20200514

<h4>Background</h4>To investigate the efficacy and safety of aerosol inhalation of recombinant human interferon α1b (IFNα1b) injection for noninfluenza viral pneumonia.<h4>Methods</h4>One hundred sixty-four patients with noninfluenza viral pneumonia were divided into IFNα1b and control groups. The IFNα1b group received routine treatment + aerosol inhalation of recombinant human IFNα1b injection (50 μg × 2 injections, bid). The control group received routine treatment + IFN analog (two injections ...[more]

PMID: 32431566

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Project description:Since poor air quality affects human health in the short and long term, much research has been performed on indoor and outdoor aerosol exposure; however, there is a lack of specific data on the exposure and health risks of inhalable aerosols that contain bioaerosol in different environments of human life. To investigate the potential exposure to inhalable aerosols (in the monitoring of particulate matter (PM) based on R modeling, variations of PM depend on the ventilation system and bioaerosols based on size distribution) in various environments, the special viability and culturability of bioaerosols and their deposition doses in the respiratory system were evaluated. We conducted exposure assessments on inhalable aerosols in various indoor environments (childcare facilities, schools, commercial buildings, elderly and homes). The fractions of PM (PM10, PM4 and PM2.5) were investigated and, for the bioaerosol, the viability, culturability, inhalation daily dose and the deposited dose of the aerosol in the respiratory system were calculated to evaluate the human health effects. For two years, the distribution of the indoor PM concentration was high in all PM fractions in schools and commercial buildings, and low in the elderly and at homes. For airborne bacteria, the highest concentrations were shown in the childcare facility during the four seasons, while airborne fungi showed high concentrations in the buildings during the spring and summer, which showed significant differences from other investigated environments (between the buildings and elderly and homes: p < 0.05). The viability and culturability for the bioaerosol showed no significant difference in all environments, and the correlation between inhalable PM and bioaerosol obtained from the six-stage impactor showed that the coefficient of determination (R2) between coarse particles (PM10-2.5, the size of stage 2-3) and cultivable airborne bacteria ranged from 0.70 (elderly and homes) to 0.84 (school) during the summer season.

Project description:BackgroundThe outbreak of a new coronavirus (SARS-CoV-2) poses a great challenge to global public health. New and effective intervention strategies are urgently needed to combat the disease.MethodsWe conducted an open-label, non-randomized, clinical trial involving moderate COVID-19 patients according to study protocol. Patients were assigned in a 1:2 ratio to receive either aerosol inhalation treatment with IFN-κ and TFF2, every 48 h for three consecutive dosages, in addition to standard treatment (experimental group), or standard treatment alone (control group). The end point was the time to discharge from the hospital. This study is registered with chictr.org.cn, ChiCTR2000030262.FindingsA total of thirty-three eligible COVID-19 patients were enrolled from February 1, 2020 to April 6, 2020, eleven were assigned to the IFN-κ plus TFF2 group, and twenty-two to the control group. Safety and efficacy were evaluated for both groups. No treatment-associated severe adverse effects (SAE) were observed in the group treated with aerosol inhalation of IFN-κ plus TFF2, and no significant differences in the safety evaluations were observed between experimental and control groups. CT imaging was performed in all patients with the median improvement time of 5.0 days (IQR 3.0-9.0) in the experimental group versus 8.5 days (IQR 3.0-17.0) in the control group (p<0.05). In addition, the experimental group had a significant shorten median time in cough relief (4.5 days [IQR 2.0-7.0]) than the control group did (10.0 days [IQR 6.0-21.0])(p<0.005), in viral RNA reversion of 6.0 days (IQR 2.0-13.0) in the experimental group vs 9.5 days (IQR 3.0-23.0) in the control group (p < 0.05), and in the median hospitalization stays of 12.0 days (IQR 7.0-20.0) in the experimental group vs 15.0 days (IQR 10.0-25.0) in the control group (p<0.001), respectively.InterpretationAerosol inhalation of IFN-κ plus TFF2 is a safe treatment and is likely to significantly facilitate clinical improvement, including cough relief, CT imaging improvement, and viral RNA reversion, thereby achieves an early release from hospitalization. These data support to explore a scale-up trial with IFN-κ plus TFF2.FundingNational Major Project for Control and Prevention of Infectious Disease in China, Shanghai Science and Technology Commission, Shanghai Municipal Health Commission.

Dataset Information

Efficacy and safety of aerosol inhalation of recombinant human interferon ?1b (IFN?1b) injection for noninfluenza viral pneumonia, a multicenter, randomized, double-blind, placebo-controlled trial.

Publications

Efficacy and safety of aerosol inhalation of recombinant human interferon α1b (IFNα1b) injection for noninfluenza viral pneumonia, a multicenter, randomized, double-blind, placebo-controlled trial.

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