Author: Denise Baez
DG Alerts
Hospitalised patients with coronavirus disease 2019 (COVID-19) who received an inhaled, nebulised formulation of interferon beta-1a (SNG001) had greater odds of improvement and recovered more rapidly from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection than patients who received placebo, according to a study published in The Lancet Respiratory Medicine.
Between March 30 and May 30, 2020, hospitalised patients with COVID-19 were randomised to receive SNG001 or placebo for up to 14 days, with post-treatment follow-up for a maximum of 28 days. A total of 48 patients received SNG001 and 50 received placebo and were included in the intention-to-treat population. Of the patients in the SNG001 group, 37 required oxygen supplementation at baseline, as did 29 of the patients assigned to placebo.
The median duration of COVID-19 symptoms before initiation of treatment was 10 days.
The odds of improvement on the World Health Organization Ordinal Scale for Clinical Improvement (OSCI) scale — the primary endpoint — were more than 2-fold greater on day 15 or day 16 for patients randomised to SNG001 (odds ratio [OR] = 2.32; 95% confidence interval [CI], 1.07-5.04; P = .033) and more than 3-fold greater on day 28 (OR = 3.15; 95% CI, 1.39-7.14; P = .006).
The OSCI is a 9-point scale, where 0 corresponds to no infection and 8 corresponds to death.
Of the patients in the placebo group, 22% developed severe disease or died (OSCI ≥5) between the first dose and day 16 compared with 13% of patients in the SNG001 group. SNG001 reduced the odds of developing severe disease or dying by 79% (OR = 0.21; 95% CI 0.04-0.97; P = .046) in the prespecified logistic regression analysis.
Over the 14-day treatment period, patients in the SNG001 group were more than twice as likely to recover as those in the placebo group (44% vs 22%; hazard ratio [HR] = 2.19; 95% CI, 1.03-4.69; P = .043). On day 28, 58% and 35% of patients in each group, respectively, had recovered. The odds of recovery on day 28 were more than 3-fold greater in the SNG001 group than in the placebo group (OR = 3.58; 95% CI, 1.41-9.04; P = .007).
There was no significant difference between treatment groups in the odds of hospital discharge or time to hospital discharge.
Secondary outcome analysis of symptoms revealed a greater improvement in breathlessness and total Breathlessness, Cough and Sputum Scale (BCSS) score over the treatment period with SNG001 versus placebo (difference between SNG001 and placebo -0.8; P = .026). The improvement in patient-reported breathlessness on a scale of 0 to 4 (with 0 corresponding to no symptoms and 4 corresponding to severe symptoms) was greater in the SNG001 group than in the placebo group over the treatment period (difference -0.6; P = .007).
The most frequently reported treatment-emergent adverse event was headache. Three patients died during the study; all deaths occurred in patients randomised to placebo.
Patients’ mean age was 57.1 years, 59% were male, and 80% were White. About half (54%) of the patients had comorbidities, including hypertension, cardiovascular disease, diabetes, chronic lung condition, or cancer. Patients in both groups were well matched by baseline characteristics, but patients in the SNG001 group had more severe disease, as judged by how many received oxygen therapy, and more patients in the placebo group had diabetes (33% vs 12%) or cardiovascular disease (30% vs 19%), and fewer had hypertension (41% vs 69%).
“These encouraging data provide a strong rationale for larger, international studies in the context of the ongoing clinical burden of COVID-19,” wrote Tom M. A Wilkinson, PhD, University Hospital Southampton, Southampton, United Kingdom, and colleagues. “In addition to a phase 3 trial of SNG001 in patients admitted to hospital with COVID-19 requiring no more than supplementary oxygen, it might be appropriate to also assess the safety and efficacy of SNG001 in ventilated, critically ill patients with COVID-19 who have evidence of active viral infection in the lungs. In view of the broad antiviral effects of interferon-β, the results of this pilot trial suggest that the efficacy of SNG001 should also be assessed in the hospital setting against other seasonal respiratory viruses, which cause considerable morbidity and mortality every year, including cases of SARS-CoV-2 co-infection, which could overwhelm healthcare systems during the coming months in the northern hemisphere.”
The study had several limitations, including the small sample size, the novelty of the OSCI at the time of the study, and the fact that the nebuliser used in this study is not suitable for use in patients requiring ventilation.
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