Oral Sabizabulin for COVID-19

NEJM Evidence

July 6, 2022

Oral Sabizabulin for High-Risk, Hospitalized Adults with Covid-19: Interim Analysis

Summarized by: 

Mazen Kherallah

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.

Oral Sabizabulin for COVID-19