Efficacy of solnatide to treat pulmonary permeability edema in SARS-CoV-2 positive patients with moderate to severe ARDS: A randomized controlled pilot-trial

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BACKGROUND: Because of the initially urgent need for treatments for COVID-19-associated acute respiratory distress syndrome (ARDS), the efficacy and tolerability of inhaled solnatide, a direct activator of the epithelial sodium channel (ENaC) under clinical investigation for the treatment of ARDS, were assessed in a pilot trial. METHODS: This randomized controlled double-blind clinical trial was performed at two study centers in Vienna, Austria. Adult mechanically ventilated patients with moderate to severe ARDS (Berlin Definition) caused by COVID-19 were randomized 1:1 to inhalation of solnatide (100 mg) or placebo twice daily for seven days. The primary outcome parameter was ventilator-free days (VFDs) within 28 days; survival was assessed at 28 and 60 days as a secondary outcome. RESULTS: A total of 30 out of the 40 planned patients were included, 15 randomized to solnatide and 15 to placebo. Then the trial was stopped early due to slow recruitment. The median VFDs were 0 in both groups (p = 0.653). Twenty out of 30 patients (66.7%) survived until day 28 [solnatide group: n = 11 (73.3%), placebo group: n = 9 (60%)]. One additional patient per group died until day 60. In total, 41 adverse events (AEs) and 10 serious AEs occurred in the solnatide group, and 26 AEs and 14 serious AEs in the placebo group. No AE was considered to be related to the study treatment. CONCLUSIONS: There was no difference in VFDs or survival between the solnatide and the placebo group. Solnatide appeared safe in this limited cohort of critically ill patients with COVID-19. REGISTRATION: EU clinical trials register, EudraCT number 2020-001244-26.

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