Inhaled ZYESAMI™ (Aviptadil Acetate) for the Treatment of Severe COVID-19
Status:
Recruiting
Trial end date:
2021-12-31
Target enrollment:
Participant gender:
Summary
Brief Summary:
SARS-CoV-2 virus infection is known to cause Lung Injury that begins as dyspnea and exercise
intolerance, but may rapidly progress to Critical COVID-19 with Respiratory Failure and the
need for noninvasive or mechanical ventilation. Mortality rates as high as 80% have been
reported among those who require mechanical ventilation, despite best available intensive
care.
Patients with severe COVID-19 by FDA definition who have not developed respiratory failure be
treated with nebulized ZYESAMI™ (aviptadil acetate, a synthetic version of Vasoactive
Intestinal Polypeptide (VIP)) 100 μg 3x daily plus Standard of Care vs. placebo + Standard of
Care using an FDA 501(k) cleared mesh nebulizer.
The primary outcome will be progression in severity of COVID-19 (i.e. critical OR severe
progressing to critical) over 28 days. Secondary outcomes will include blood oxygenation as
measured by pulse oximetry, dyspnea, exercise tolerance, and levels of TNFα IL-6 and other
cytokines.