PT  - JOURNAL ARTICLE
AU  - Francis, Nick A
AU  - Monk, Phillip D
AU  - Nuttall, Jacqueline
AU  - Oliver, Thomas
AU  - Simpson, Catherine
AU  - Brookes, Jody L
AU  - Tear, Victoria J
AU  - Thompson, Angela G
AU  - Batten, Toby N
AU  - Mankowski, Marcin
AU  - Wilkinson, Thomas MA
TI  - Feasibility of home administration of nebulised interferon ß-1a (SNG001) for COVID-19: a remote study
AID  - 10.3399/BJGPO.2023.0089
DP  - 2023 Dec 01
TA  - BJGP Open
PG  - BJGPO.2023.0089
VI  - 7
IP  - 4
4099  - http://bjgpopen.org/content/7/4/BJGPO.2023.0089.short
4100  - http://bjgpopen.org/content/7/4/BJGPO.2023.0089.full
SO  - BJGP Open2023 Dec 01; 7
AB  - Background Effective therapeutics given early to high-risk ambulatory patients with coronavirus disease 2019 (COVID-19) could improve outcomes and reduce overall healthcare burden. However, conducting site visits in non-hospitalised patients, who should remain isolated, is problematic.Aim To evaluate the feasibility of a purely remote (virtual) study in non-hospitalised patients with COVID-19; and the efficacy and safety of nebulised recombinant interferon-β1a (SNG001) in this setting.Design & setting Randomised, double-blind, parallel-group study, which was conducted remotely.Method Eligible patients aged ≥65 years (or ≥50 years with risk factors) with COVID-19 and not requiring hospital admission were recruited remotely. They were randomised to SNG001 or placebo once-daily via nebuliser for 14 days. The main outcomes were assessments of feasibility and safety, which were all conducted remotely.Results Of 114 patients treated, 111 (97.4%) completed 28 days of follow-up. Overall compliance to study medication was high, with ≥13 doses taken by 89.7% and 92.9% of treated patients in the placebo and SNG001 groups, respectively. Over the course of the study, only two patients were hospitalised, both in the placebo group; otherwise there were no notable differences between treatments for the efficacy parameters. No patients withdrew owing to an adverse event, and a similar proportion of patients experienced on-treatment adverse events in the two treatment groups (64.3% and 67.2% with SNG001 and placebo, respectively); most were mild or moderate and not treatment-related.Conclusion This study demonstrated that it is feasible to conduct a purely virtual study in community-based patients with COVID-19, when the study included detailed daily assessments and with medication administered via nebuliser.