July 6, 2022
Oral Sabizabulin for High-Risk, Hospitalized Adults with Covid-19: Interim Analysis
What was the research question?
Does the use of oral Sabizabulin improve the outcome for high risk, hospitalized adults infected with COVID-19 compared to placebo?
How did they do it?
A multicenter, randomized placebo-controlled clinical trial in 27 participating sites in 5 countries (USA, Brazil, Bulgaria, Argentina, and Mexico).
204 patients with moderate to severe COVID-19 infection who were at high risk of acute respiratory distress syndrome and death, were randomized at a 2:1 ratio to receive 9 mg of oral Sabizabulin (134 patients) or placebo (70 patients) daily for 21 days or until discharge.
Exclusion criteria included pregnancy or breast feeding, WHO 7 score (on mechanical ventilation with one more organ support), LFTs >3X upper normal, elevated bilirubin above normal, or creatinine clearance <60 ml/min.
Primary outcome was 60-day all-cause mortality, and secondary outcomes were days in the ICU, on mechanical ventilation, and in the hospital.
First interim analysis at 150 patients.
What did they find?
60-day all-cause mortality was significantly lower in the Sabizabulin group compared to the placebo group (20.2% vs. 45.1%, 24.9-point difference and 55.2% relative reduction in death, OR, 3.23; 95% CI: 1.45-7.22, p=0.0042). Number needed to treat is 4.
Sabizabulin resulted in a relative reduction of 43% in ICU days, 49% in ventilator days, and 26% in hospital days compared to placebo.
Benefit was seen regardless of sex, BMI, geographic area, age, WHO ordinal score, treatment received, or baseline comorbidities.
Sabizabulin has an acceptable side effect and safety profile in the first 150 patients who were analyzed.
Are there any limitations?
The trial was stopped early due to efficacy but was only short of 6 patients (planned for 210 with 92.8% power to detect 50% relative reduction in death. Similar results obtained for when all 204 patients were analyzed.
What does it mean?
Sabizabulin reduced 60-day all-cause mortality in hospitalized patients with moderate to severe COVID-19 infection who are at high risk of progression to ARDS or death with fewer incidence of adverse events compared to placebo.