Abstract
Background Despite the availability of vaccines and therapies, patients are being hospitalised with COVID-19. Interferon-β is a naturally-occurring protein that stimulates host immune responses against most viruses, including SARS-CoV-2. SNG001 is a recombinant interferon-β1a formulation delivered to the lungs via nebuliser. SPRINTER assessed the efficacy and safety of SNG001 in adults hospitalised due to COVID-19 who required oxygen via nasal prongs or mask.
Methods Patients were randomised double-blind to SNG001 (N=309) or placebo (N=314) once-daily for 14 days plus standard of care (SoC). The primary objective was to evaluate recovery after administration of SNG001 versus placebo, in terms of times to hospital discharge and recovery to no limitation of activity. Key secondary endpoints were: progression to severe disease or death; progression to intubation or death; and death.
Results Median time to hospital discharge was 7.0 and 8.0 days with SNG001 and placebo, respectively (hazard ratio 1.06 [95%CI 0.89, 1.27]; p=0.51); time to recovery was 25.0 days in both groups (1.02 [0.81, 1.28]; p=0.89). There were no significant SNG001–placebo differences for the key secondary endpoints, with a 25.7% relative risk reduction in progression to severe disease or death (10.7% and 14.4%, respectively; odds ratio 0.71 [0.44, 1.15]; p=0.161). Serious adverse events were reported by 12.6% and 18.2% patients with SNG001 and placebo, respectively.
Conclusions Although the primary objective of the study was not met, SNG001 had a favourable safety profile, and the key secondary endpoints analysis suggested that SNG001 may have prevented progression to severe disease.
Study registration number: ISRCTN85436698
Footnotes
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Conflicts of interest: In addition to the writing support declared above, the authors have the following conflicts of interest to declare.
Conflicts of interest: PDM is an employee of Synairgen Research plc, the parent company of Synairgen Research Ltd (and such costs are met by Synairgen Research Ltd), the sponsor of this trial, and owns shares and has options on shares in Synairgen plc.
Conflicts of interest: JLB is an employee of Synairgen Research Ltd, the sponsor of this trial, and has options on shares in Synairgen plc.
Conflicts of interest: VJT is an employee of Synairgen Research Ltd, the sponsor of this trial, and owns shares and has and has options on shares in Synairgen plc.
Conflicts of interest: TNB provided statistical support, programming and consultancy to Synairgen Research Ltd via a contract with his employer, Veramed Ltd.
Conflicts of interest: MM Provided consulting services to Synairgen Research Ltd, the sponsor of this trial, with all payments made to tranScrip Ltd.
Conflicts of interest: TA-V has no other conflicts of interest to disclose.
Conflicts of interest: MGC has no other conflicts of interest to disclose.
Conflicts of interest: DPSD declares grants from GlaxoSmithKline (Supported Studies Programme), and Birmingham Health Partners CARP Fellowship, honorarium for meeting and podcast from Boehringer Ingelheim, support to attend congresses from Boehringer Ingelheim (no payment received), patent 0406271.7, filed 21st March 2005 (‘Mycobacterium tuberculosis infection diagnostic text’), and participation in a Data Safety Monitoring Board or Advisory Board from AstraZeneca, Boehringer Ingelheim and the HAP-FAST trial, all outside the scope of this manuscript.
Conflicts of interest: MK declares the receipt of funding to her institution from Synairgen Research Ltd, the sponsor of this trial. Outside the scope of the trial she declares funds paid to her institution from the National Institutes of Health, American Lung Association, Sanofi-Regeneron and AstraZeneca, consulting fees from AstraZeneca, Sanofi-Regeneron and Genentech, one patent issued and one pending for which she received no funds directly (she is Chief Medical Officer and Co-founder RaeSedo, Inc), funds for the participation in a Data Safety Monitoring Board for the ALUND Study, funds for a leadership role of the National Heart, Lung and Blood Scientific Advisory Council (NIH), and the future receipt of stock options in RaeSedo, Inc.
Conflicts of interest: CEB declares grants and consulting fees paid to his institution from GlaxoSmithKline, AstraZeneca, Boehringer Ingelheim, Novartis, Chiesi, Genentech, Roche, Sanofi, Regeneron, Mologic and 4DPharma, all outside the scope of this manuscript.
Conflicts of interest: FJG declares the receipt of consulting fees paid to tranScrip Ltd from Synairgen Research plc, the sponsor of this trial, and participation in a Data Safety Monitoring Board for Synairgen. She is also president of the Faculty of Pharmaceutical Medicine of three UK Royal College of Physicians.
Conflicts of interest: STH received payments as non-executive director of, and owns shares in, Synairgen plc, the parent company of the sponsor of this trial.
Conflicts of interest: RD declares the receipt of consulting fees and payment for participation in a Data Safety Monitoring Board or Advisory Board from Synairgen Research Ltd, the sponsor of this trial. RD owns shares in Synairgen plc, the parent company of the sponsor of this trial. Outside the trial, he declares payment or honoraria from Regeneron, GlaxoSmithKline and Kymab
Conflicts of interest: TMAW received research funding and consultancy fees from Synairgen Research Ltd, the sponsor of this trial. Outside the trial, he declares research grants from the National Institute for Health and Care Research, Medical Research Council, Bergenbio, AstraZeneca, UCB and Janssen, consultancy fees from AstraZeneca, Valneva, Olam Pharma, Janssen and My mHealth, lecture fees from AstraZeneca, Boehringer Ingelheim and Roche, participation on a Data Safety Monitoring Board for Valneva, and that he holds stock in My mHealth.
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- Received November 9, 2022.
- Accepted December 6, 2022.
- Copyright ©The authors 2022
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