Publication date: Sep 05, 2023
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. To evaluate: feasibility of a purely remote (virtual) study in non-hospitalised patients with COVID-19; and efficacy and safety of nebulised recombinant interferon-β1a (SNG001) in this setting. Randomised, double-blind, parallel-group, conducted remotely. 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, all conducted remotely. 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 due 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/moderate and not treatment-related. 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. NCT04385095.
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