About: A clinical pilot study on the safety and efficacy of aerosol inhalation treatment of IFN-κ plus TFF2 in patients with moderate COVID-19

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About: A clinical pilot study on the safety and efficacy of aerosol inhalation treatment of IFN-κ plus TFF2 in patients with moderate COVID-19 Goto Sponge NotDistinct Permalink

An Entity of Type : schema:ScholarlyArticle, within Data Space : wasabi.inria.fr associated with source document(s)

Attributes	Values
type	Academic Article research paper schema:ScholarlyArticle
isDefinedBy	Covid-on-the-Web dataset
has title	A clinical pilot study on the safety and efficacy of aerosol inhalation treatment of IFN-κ plus TFF2 in patients with moderate COVID-19
Creator	Li, Min Song, Zhigang Xu, Jianqing Zhang, Xiaoyan Wang, Lin Lu, Hongzhou Liu, Yan Yang, Zongguo Zhang, Lin Liu, Li Fu, Weihui Chen, Jun Xia, Lu Wang, Mei Ling, Yun Zhu, Tongyu Shan, Fei Yan, Jin Cheng, Xiaobo Hu, Huiliang Jiang, Rongrong Mao, Xiaoting Steinhart, Corklin
Source	Elsevier; Medline; PMC
abstract	BACKGROUND: The 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. METHODS: We 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. FINDINGS: A 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. INTERPRETATION: Aerosol 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. FUNDING: National Major Project for Control and Prevention of Infectious Disease in China, Shanghai Science and Technology Commission, Shanghai Municipal Health Commission.
has issue date	2020-07-29(xsd:dateTime)
bibo:doi	10.1016/j.eclinm.2020.100478
bibo:pmid	32838238
has license	no-cc
sha1sum (hex)	e7f25593b14198af09479478c8f0b2707eccb4e1
schema:url	https://doi.org/10.1016/j.eclinm.2020.100478
resource representing a document's title	A clinical pilot study on the safety and efficacy of aerosol inhalation treatment of IFN-κ plus TFF2 in patients with moderate COVID-19
has PubMed Central identifier	PMC7388798
has PubMed identifier	32838238
schema:publication	EClinicalMedicine
resource representing a document's body	covid:e7f25593b14198af09479478c8f0b2707eccb4e1#body_text
is schema:about of	named entity 'TFF2' named entity 'viral RNA' named entity 'TFF2' named entity 'control group' named entity '37 days' named entity 'control group' named entity 'IFNk' named entity 'Public Health' named entity 'prognosis' named entity 'HCQ' named entity 'adverse reactions' named entity 'Aerosolized' named entity 'viral RNA' named entity 'viral shedding' named entity 'interleukin 33' named entity 'Shanghai' named entity 'COVID' named entity 'infection' named entity 'SARS-CoV-2' named entity 'COVID' named entity 'rat' named entity 'TFF2' named entity 'vitamin' named entity 'WBCs' named entity 'aerosol' named entity 'COVID' named entity 'clinical trial' named entity 'effective dose' named entity 'Traditional Chinese Medicine' named entity 'TFF2' named entity 'cough' named entity 'April 6' named entity 'TFF2' named entity 'TFF2' named entity 'statistical bias' named entity 'Huh7' named entity 'WBCs' named entity 'Patent' named entity 'Patent' named entity 'electronic medical record' named entity 'illness symptoms' named entity 'IFN' named entity 'inhalation' named entity 'inflammatory response' named entity 'aerosol' named entity 'viral replication' named entity 'experimental group' named entity 'influenza virus' named entity 'TFF2' named entity 'inhalation' named entity 'informed consent' named entity 'Health Commission' named entity 'epithelial' named entity 'control group' named entity 'pneumonia' named entity 'Shanghai' named entity 'type I interferons' named entity 'IFN' named entity 'Declaration of Helsinki'

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