key: cord-1003523-lmhov1cd
authors: Zheng, Fang; Zhou, Yanwen; Zhou, Zhiguo; Ye, Fei; Huang, Baoying; Huang, Yaxiong; Ma, Jing; Zuo, Qi; Tan, Xin; Xie, Jun; Niu, Peihua; Wang, Wenlong; Xu, Yun; Peng, Feng; Zhou, Ning; Cai, Chunlin; Tang, Wei; Xiao, Xinqiang; Li, Yi; Zhou, Zhiguang; Jiang, Yongfang; Xie, Yuanlin; Tan, Wenjie; Gong, Guozhong
title: Reply to “Novaferon, Treatment in COVID-19 Patients”
date: 2020-11-25
journal: Int J Infect Dis
DOI: 10.1016/j.ijid.2020.11.179
sha: 7e372b78237a74a7f89cc8093b0d9921c8efcbd0
doc_id: 1003523
cord_uid: lmhov1cd

nan

This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. We read with great interest the letter by Janapala et al about our study of Novaferon as a potential antiviral drug in a randomized trial conducted in February, 2020 . The main points raised by these authors are addressed below.

Aerosolized IFNα treatment for respiratory viral infections has been generally practiced and recommended for COVID-19 treatment in China. The recommended dose of IFNα was 5MIU by inhalation twice daily which equaled to a daily dose of 100μg

IFNα protein (10MIU daily, relative activity 1X10 8 IU/mg). As a mutant of IFNα with enhanced antiviral potency, the aerosolized administration of Novaferon was thus considered as a potential treatment for COVID-19. In addition, up to 40μg Novaferon by daily injection has been applied to oncologic patients and were well tolerated in a phase I trial (available at the official web site of Chinese Drug Administration-NMPA).

The inhaled dose of 20μg Novaferon twice daily (40μg daily) for COVID was determined accordingly. 

A Trial of Lopinavir-Ritonavir in Adults Hospitalized with Severe Covid-19

Lopinavir-ritonavir in patients admitted to hospital withCOVID-19 (RECOVERY): a randomized, controlled, open-label,platformtrial.The Lancet

World Health Organization. WHO Handbook for reporting results of Cancer Treatment

SARS-CoV-2 clearance in COVID-19 patients with Novaferon treatment: A randomized, open-label, parallelgroup trial. et al

Viral load dynamics and disease severity in patients infected with SARS-CoV-2 in Zhejiang province, China, January-March2020: retrospective cohort study

Currently several toxicity grading scales are applied to clinical studies. The referred WHO toxicity grading scale in our paper is listed here as a reference (WHO offset publication No. 48, 1979). 

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as potential conflicts of interest.

The study was anonymous, and the protocol was approved by the Ethics Committee of the First Hospital of Changsha, according to the Declaration of Helsinki, 2013. Written informed consent was obtained from all participants.

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.