PT - JOURNAL ARTICLE AU - Phillip D. Monk AU - Jody L. Brookes AU - Victoria J. Tear AU - Toby N. Batten AU - Marcin Mankowski AU - Tatjana Adzic-Vukicevic AU - Michael G. Crooks AU - Davinder P.S. Dosanjh AU - Monica Kraft AU - Christopher E. Brightling AU - Felicity J. Gabbay AU - Stephen T. Holgate AU - Ratko Djukanovic AU - Tom M.A. Wilkinson ED - , TI - Nebulised interferon-β1a (SNG001) in hospitalised COVID-19: SPRINTER phase III study AID - 10.1183/23120541.00605-2022 DP - 2023 Mar 01 TA - ERJ Open Research PG - 00605-2022 VI - 9 IP - 2 4099 - http://openres.ersjournals.com/content/9/2/00605-2022.short 4100 - http://openres.ersjournals.com/content/9/2/00605-2022.full SO - erjor2023 Mar 01; 9 AB - Background Despite the availability of vaccines and therapies, patients are being hospitalised with coronavirus disease 2019 (COVID-19). Interferon (IFN)-β is a naturally occurring protein that stimulates host immune responses against most viruses, including severe acute respiratory syndrome coronavirus 2. SNG001 is a recombinant IFN-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 end-points 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 (HR) 1.06 (95% CI 0.89–1.27); p=0.51); time to recovery was 25.0 days in both groups (HR 1.02 (95% CI 0.81–1.28); p=0.89). There were no significant SNG001–placebo differences for the key secondary end-points, with a 25.7% relative risk reduction in progression to severe disease or death (10.7% and 14.4%, respectively; OR 0.71 (95% CI 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 end-points analysis suggested that SNG001 may have prevented progression to severe disease.Although the primary objective was not met, potentially due to improved standard of care, SNG001 had a favourable safety profile and key secondary end-points analysis suggested that SNG001 may have impacted progression of COVID-19 to severe disease https://bit.ly/3huTDX9