Efficacy endpoints
DISEASE, COMPLICATIONS
The primary efficacy endpoint was the relative reduction in viral load (day 4 vs. baseline) in each gene (ORF1ab, N Protein, S Protein) in the active treatment group (domperidone plus SOC) as compared with the control group (placebo plus SOC). Secondary efficacy endpoints were the reduction in viral load (day 7 vs. baseline and day 14 vs. baseline); the proportion of patients with a negative RT-qPCR test for SARS-CoV-2 (Ct value >35 in at least two of three genes); the time to achieve a negative viral load from baseline; and the comparison of the clinical efficacy in the two study arms, including reduction in the severity of each symptom (0–10 NRS score) at days 4, 7, 14 and 28 as compared with baseline; proportion of patients with clinical improvement and time to clinical improvement; proportion of patients with disappearance of each symptom at days 4, 7, 14 and 28, and time to disappearance; proportion of asymptomatic patients at days 4, 7, 14 and 28; proportion of patients requiring medical care, admission to the hospital, oxygen therapy and development of complications related to COVID-19 disease over the study period; 28-day mortality rate; mortality rate after the end of study; and safety of domperidone or placebo.