Safety and efficacy of inhaled nebulised interferon beta-1a (SNG001) for treatment of SARS-CoV-2 infection: a randomised, double-blind, placebo-controlled, phase 2 trial

Accepted/In Press date: 19 October 2020

e-pub ahead of print date: 12 November 2020

Published date: February 2021

Additional Information: Funding Information: This study was funded by Synairgen Research, UK. TMAW is supported in part by the NIHR Southampton Biomedical Research Centre. L-PH is supported in part by the NIHR Oxford Biomedical Research Centre. We thank all patients who volunteered for the study and clinical and research teams at all the participating clinical centres and the NIHR Respiratory Translational Research Collaboration for support in trial delivery. We are grateful to Antigoni Ekonomou of Niche Science & Technology for medical writing services and editorial assistance with the manuscript. We thank also Alastair Watson for helping with the preparation of the manuscript and coordination of the submission. Funding Information: This study was funded by Synairgen Research, UK. TMAW is supported in part by the NIHR Southampton Biomedical Research Centre. L-PH is supported in part by the NIHR Oxford Biomedical Research Centre. We thank all patients who volunteered for the study and clinical and research teams at all the participating clinical centres and the NIHR Respiratory Translational Research Collaboration for support in trial delivery. We are grateful to Antigoni Ekonomou of Niche Science & Technology for medical writing services and editorial assistance with the manuscript. We thank also Alastair Watson for helping with the preparation of the manuscript and coordination of the submission. Funding Information: PDM is a Director of Synairgen Research (a University of Southampton spin-out company), is an employee and Director of Synairgen (the parent company of Synairgen Research), and own shares and holds share options in Synairgen. RJM is a Director of Synairgen Research, is an employee and Director of Synairgen, and own shares and holds share options in Synairgen. VJT is an employee of Synairgen Research and holds share options in Synairgen. PDM and VJT also have a patent (GB 2011216.5: Use of inhaled interferon-beta to improve outcome in SARS-CoV-2 infected patients) pending. JB is an employee of Synairgen Research and holds share options in Synairgen. MM reports fees as a consultant from Synairgen Research, outside of the submitted work. FJG is a Managing Partner of Transcrip Partners and reports personal fees from TranScrip Partners who supported Synairgen for the study, and personal fees from TranScrip Partners outside of this work. FJG was also a member of the independent data safety monitoring committee. DED is a co-founder of Synairgen Research, owns shares in Synairgen, and has received personal fees and other fees as a consultant to Synairgen Research during and outside of the conduct of the trial. DED has also received a grant from Boehringer Ingelheim for fibrosis studies unrelated to the trial and has patents relating to antiviral therapy for respiratory diseases (PCT/GB2005/050031) and the use of interferon-beta as a form of antiviral therapy for respiratory diseases (WO2005087253A3), with royalties paid to the University of Southampton and the inventors. STH is a co-founder of Synairgen Research, owns shares in the company, and has received personal fees as a Non-Executive Director and Consultant of Synairgen Research outside of the submitted work. STH also has patents for the use of interferon-beta as a form of antiviral therapy for respiratory diseases (WO2005087253A3 WIPO [PCT]; issued), antiviral therapy for respiratory diseases (US20090257980A1; issued), and inhaled interferon beta for COVID-19 (pending); STH is also Chair of the Academy of Medical Sciences for the report Preparing for a challenging winter 2020/21, published July 14, 2020. L-PH reports receiving funds from Synairgen Research to carry out a phase 1 clinical trial at her institution during the conduct of the study and grants from Celgene for a research study in fibrosis, outside of the submitted work. TC reports receipt of personal fees from BioMerieux and BioFire, Roche, Janssen, Cidara Therapeutics, Synairgen Research, and Randox; non-financial support from BioMerieux and BioFire, and Qiagen; and other fees from Synairgen Research outside of the submitted work. RD reports receiving fees for lectures at symposia organised by Novartis, AstraZeneca, and Teva, consultation fees for Teva and Novartis as a member of advisory boards, and participation in a scientific discussion about asthma organised by GlaxoSmithKline. RD is a co-founder, current consultant, and owns shares in Synairgen Research. TMAW reports receipt of personal fees and travel support from My mHealth, grants and personal fees from GlaxoSmithKline; grants and personal fees from AstraZeneca; personal fees from Boehringer Ingelheim; and grants and personal fees from Synairgen Research, outside of the submitted work. TNB declares no competing interests. Publisher Copyright: © 2021 Elsevier Ltd

Local EPrints ID: 445094

URI: http://eprints.soton.ac.uk/id/eprint/445094

DOI: doi:10.1016/S2213-2600(20)30511-7

ISSN: 2213-2600

PURE UUID: b2b7a24e-4259-4399-9f95-ee5b5de422c6

ORCID for Donna E Davies: orcid.org/0000-0002-5117-2991

ORCID for Tristan Clark: orcid.org/0000-0001-6026-5295

ORCID for Ratko Djukanovic: orcid.org/0000-0001-6039-5612

Date deposited: 19 Nov 2020 17:32

Last modified: 17 Mar 2024 06:05