A total of 40 eligible subject will be enrolled and randomized in a 1:1 ratio to receive either dupilumab or placebo, stratifying on the disease severity measured by the required oxygen ≤ 15L or > 15L by nasal cannula. Both arms will receive standard of care management per current National Institutes of Health (NIH) COVID-19 treatment guidelines (8) in addition to their randomized treatments. Patients will be followed prospectively for up to 360 days after enrollment.~As an extension to the randomized double-blind placebo-controlled trial assessing dupilumab for treatment of those hospitalized with acute moderate to severe COVID-19, this 1 year follow up assessment of this study cohort post recovery from COVID-19 for evaluation of pulmonary function testing (PFT), pulmonary imaging, immune biomarkers and symptoms.
This is a randomized, double-blind, placebo-controlled, superiority phase IIa trial to assess the safety and efficacy of dupilumab use in hospitalized patients with moderate to severe COVID-19 infection.~We are also conducting a 1 year follow-up study. This study aims to determine the difference in post recovery pulmonary function between those randomized to dupilumab arm versus placebo for acute moderate to severe COVID-19.