SPRINTER: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial to Determine the Efficacy and Safety of Inhaled Interferon Beta-1a (SNG001) for the Treatment of Patients Hospitalised Due to COVID-19 (NCT04732949)

Abstract

<b>Rationale:</b> Interferon beta (IFN-β) is key in host defence against viruses but can be suppressed by virus or host factors locally at the site of infection. Inhalation of SNG001 (IFN-β-1a nebuliser solution) aims to restore lung IFN-β levels. <b>Methods:</b> Adults hospitalised due to COVID-19 requiring low flow oxygen were randomized to receive SNG001 (314) or placebo (309) OD for 14 days, plus standard-of-care. Efficacy was assessed by change in clinical condition using the WHO 9-point Ordinal Scale for Clinical Improvement (OSCI). Primary endpoints: time to discharge (OSCI ≤2) and time to recovery (OSCI ≤1). Key secondary endpoints: progression to severe disease or death (OSCI ≥5), progression to intubation or death (OSCI ≥6), and death. <b>Results:</b> Most patients were discharged rapidly from hospital and there was no effect of SNG001 on time to discharge or recovery. However, there was an encouraging signal for prevention of progression to severe disease or death (ITT 26% relative risk reduction (RRR); Odds Ratio (95% CI): 0.71 (0.44, 1.15); Per Protocol 36% RRR; OR 0.63 (0.35, 1.13)). <i>Post hoc</i> analyses supported this observation with enhanced effects favouring SNG001 in subgroups at higher risk of progression (≥65 years; ≥1 comorbidity; oxygen saturation ≤92% and/or respiratory rate ≥21 breaths/min on oxygen). <b>Conclusion:</b> If the encouraging signal in the relative risk of disease progression or death (~30% reduction) observed in this 300 patient/arm trial were confirmed in a larger trial, SNG001 could become a useful treatment option for hospitalised COVID-19 patients.