Correction: A multi-center randomized prospective study on the treatment of infant bronchiolitis with interferon α1b nebulization

Chen, Lina; Shi, Mingfang; Deng, Quanmin; Liu, Wenjun; Li, Qin; Ye, Piao; Xiao, Yu; Zhang, Benjin; Xu, Yan; Li, Xiaolan; Yang, Yao-Lun; Li, Min; Yan, Yi; Xu, Zhe; Yu, Jing; Xiang, Long; Tang, Xiaojun; Wan, Guangping; Cai, Qiang; Wang, Li; Bo, Hu; Xie, Liang; Li, Gen; Xie, Lunyan; Liu, Xiaoyun; Liu, Chunyan; Li, Li; Chen, Lijie; Jiang, Xiaobin; Huang, Yana; Wang, Si; Guo, Jiang; Shi, Yan; Wang, Xiaofang; Zhao, Zhiyong; Li, Yan; Liu, Yanru; Fu, Qiang; Zeng, Yan; Zou, Yan; Ding-yuan, Liu; Wan, Deyun; Ai, Tao; Liu, Hanmin

doi:10.1371/journal.pone.0231911

Cited by 11 publications

(1 citation statement)

References 2 publications

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“…A multicenter, randomized, prospective study on pediatric patients with respiratory syncytial virus investigated the use of nebulized INFα-1b compared with the subcutaneous injection. The study revealed that the nebulized form has a faster onset of action, a direct action on the mucosal epithelial cells in the lungs, less systemic adverse effects, and is less invasive to the pediatric population compared with the subcutaneous form [ 105 ].…”

Section: Non-specific Immune Modulatorsmentioning

confidence: 99%

Pharmaco-Immunomodulatory Therapy in COVID-19

Rizk

Kalantar-Zadeh

Mehra

et al. 2020

Drugs

248

244

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The severe acute respiratory syndrome coronavirus 2 associated coronavirus disease 2019 (COVID-19) illness is a syndrome of viral replication in concert with a host inflammatory response. The cytokine storm and viral evasion of cellular immune responses may play an equally important role in the pathogenesis, clinical manifestation, and outcomes of COVID-19. Systemic proinflammatory cytokines and biomarkers are elevated as the disease progresses towards its advanced stages, and correlate with worse chances of survival. Immune modulators have the potential to inhibit cytokines and treat the cytokine storm. A literature search using PubMed, Google Scholar, and ClinicalTrials.gov was conducted through 8 July 2020 using the search terms 'coronavirus', 'immunology', 'cytokine storm', 'immunomodulators', 'pharmacology', 'severe acute respiratory syndrome 2', 'SARS-CoV-2', and 'COVID-19'. Specific immune modulators include anti-cytokines such as interleukin (IL)-1 and IL-6 receptor antagonists (e.g. anakinra, tocilizumab, sarilumab, siltuximab), Janus kinase (JAK) inhibitors (e.g. baricitinib, ruxolitinib), anti-tumor necrosis factor-α (e.g. adalimumab, infliximab), granulocyte-macrophage colonystimulating factors (e.g. gimsilumab, lenzilumab, namilumab), and convalescent plasma, with promising to negative trials and other data. Non-specific immune modulators include human immunoglobulin, corticosteroids such as dexamethasone, interferons, statins, angiotensin pathway modulators, macrolides (e.g. azithromycin, clarithromycin), hydroxychloroquine and chloroquine, colchicine, and prostaglandin D2 modulators such as ramatroban. Dexamethasone 6 mg once daily (either by mouth or by intravenous injection) for 10 days may result in a reduction in mortality in COVID-19 patients by one-third for patients on ventilators, and by one-fifth for those receiving oxygen. Research efforts should focus not only on the most relevant immunomodulatory strategies but also on the optimal timing of such interventions to maximize therapeutic outcomes. In this review, we discuss the potential role and safety of these agents in the management of severe COVID-19, and their impact on survival and clinical symptoms. Key Points COVID-19 is a syndrome of viral replication and a host inflammatory response. Tackling the immune response may be as important as addressing viral replication. Specific and non-specific immune modulators have the potential to inhibit cytokines and quell the cytokine storm.

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Section: Non-specific Immune Modulatorsmentioning

confidence: 99%

Pharmaco-Immunomodulatory Therapy in COVID-19

Rizk

Kalantar-Zadeh

Mehra

et al. 2020

Drugs

248

244

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What we know so far about Coronavirus Disease 2019 in children: A meta‐analysis of 551 laboratory‐confirmed cases

Zhang

Peres

Silva

et al. 2020

Pediatric Pulmonology

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Safety, Tolerability, and Pharmacokinetics of Nebulized GB05-Human IFNα1b Inhalation Solution: A Randomized, Placebo-Controlled, Dose-Escalation Phase I Study in Healthy Chinese Adult Volunteers

Peng,

Zhang,

Lin

et al. 2024

Infect Dis Ther

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Introduction Human respiratory syncytial virus (RSV) is the leading cause of lower respiratory tract infection, especially in children and older people. However, no effective treatment is currently available. Type I interferons (IFNs) are a group of cytokines that help regulate the activity of the immune system. GB05, human IFNα1b inhalation solution, was developed under US Food and Drug Administration (FDA) standard guidelines to combat RSV infection. This randomized, double-blind, placebo-controlled, dose-escalation phase I trial evaluated the safety, tolerability, and pharmacokinetics of nebulized GB05. Methods A total of 35 eligible healthy Chinese adult volunteers were enrolled in this study. In the single ascending dose (SAD) study, volunteers were randomized into 0.2, 0.6, 1.2, and 1.8 million IU of GB05 or placebo. In the multiple ascending dose (MAD) study, volunteers received 1.2 or 1.8 million IU of GB05 or placebo for four consecutive days. Safety, tolerability, immunogenicity, and plasma pharmacokinetics were assessed for all groups. Results All adverse events were mild or moderate and resolved spontaneously. The most common adverse event was decreased white blood cell count (8.6% in SAD and 10% in MAD). No serious adverse events, deaths, or adverse events that reached the termination criteria occurred during the study. In SAD, the maximum concentration and area under the curve increased across the dose range of 1.2–1.8 million IU in a non-linear relationship. The maximum plasma concentration after GB05 nebulization (1.06 IU/ml in the 1.8 million IU group) reflected a low concentration in the blood, suggesting a better lung uptake of GB05 and reduced incidence or risks of adverse events. In MAD, a steady state was reached after continuous administrations of twice daily for 3 days. Conclusions Overall, nebulized GB05 exhibited satisfactory safety, tolerability, and favorable pharmacokinetic (PK) profiles in healthy adult volunteers, supporting further clinical investigation in patients infected with respiratory syncytial virus. Clinical Trial Registration ClinicalTrials.gov Identifier NCT06277167.

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Correction: A multi-center randomized prospective study on the treatment of infant bronchiolitis with interferon α1b nebulization

Cited by 11 publications

References 2 publications

Pharmaco-Immunomodulatory Therapy in COVID-19

Pharmaco-Immunomodulatory Therapy in COVID-19

What we know so far about Coronavirus Disease 2019 in children: A meta‐analysis of 551 laboratory‐confirmed cases

Safety, Tolerability, and Pharmacokinetics of Nebulized GB05-Human IFNα1b Inhalation Solution: A Randomized, Placebo-Controlled, Dose-Escalation Phase I Study in Healthy Chinese Adult Volunteers

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