Cardiometabolic disease may confer increased risk of adverse outcomes in COVID-19 patients by
activation of the aldose reductase pathway, a trigger of the inflammatory cascade. The study
team hypothesizes that aldose reductase inhibition with AT-001 (caficrestat) might represent
a novel therapeutic approach to reduce inflammation and risk of adverse outcomes in diabetic
patients with COVID-19.
An open-label pilot study to assess safety, tolerability and efficacy of AT-001 in
hospitalized COVID-19 patients with history of diabetes mellitus and heart disease will be
conducted. Eligible participants will be treated with AT-001 1500 mg twice daily for up to 14
days. Safety, tolerability, survival and length of hospital stay data were compared with
matched controls from a contemporaneous registry of COVID-19 patients.