Amorphical performed study aimed to establish the safety, tolerability, and efficacy of ACC, named AMOR-18, for treating hospitalized patients with moderate-to severe SARS-CoV-2, administered as a combination of sublingual powder and inhaled suspensions alongside the best available treatment (BAT).
After a successful safety study with six patients in Stage 1, the double-blind study was performed on sixty patients that were randomized to the active and placebo arms with similar DOS severity.
The most significant outcome was the prevention of ICU transfer and death (0%) in the active arm compared to seven ICU transfers and three deaths in the placebo arm (23%; Fisher’s P=0.011).
The patient improvement rate was significantly higher in the ACC (93%; 90% CI=82- 98%) compared to the placebo arm (73%; 59-84) in the intention-to-treat sets. All patients in the active arm were discharged within 10 days from treatment initiation, and only one related adverse effect (constipation) was reported.
There were no significant differences in responses by age, gender, comorbidities, and vaccination status