Inhaled ZYESAMI (Aviptadil Acetate) for Treatment of Severe COVID-19 (NCT05137795) | Clinical Trial Compass
WithdrawnPhase 3
Inhaled ZYESAMI (Aviptadil Acetate) for Treatment of Severe COVID-19
Stopped: Sponsor decision
0Started 2021-12-15
Plain-language 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.
Who can participate
Age range18 Years – 85 Years
SexALL
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Inclusion criteria
✓. Severe COVID-19 , as defined by clinical signs indicative of severe systemic illness with COVID-19, being given oxygenation and meeting
✓. Positive test by standard RT-PCR assay or equivalent within last 7 days
✓. Physician determination that patient is on SOC therapy, and will receive standard of care if patient progresses to Critical COVID-19, patient must be full CODE
Exclusion criteria
✕. Evidence of Critical COVID-19
✕. Inability to utilize nebulized drugs, or history of bronchospasm with inhaled medications
✕. Age \<12 years;
✕. Mean arterial pressure \< 65 mm Hg after initial hospital stabilization,
✕. Non-COVID-19 irreversible underlying condition with projected fatal course within 6 months or with high risk of mortality;
✕. Immunosuppressive treatment for transplant or other diseases associated with high mortality;
✕. Stage IV cancer or cancer on active treatment with chemotherapy immunotherapy or checkpoint inhibitors; acute renal failure or chronic renal insufficiency with GFR less than 30; CHF New York Heart Association class III or IV, new neurologic disorder in the last 3 months or chronic neurologic disorder or other that would impact on assessing the resolution of severe COVID-19 respiratory failure
✕. Myocardial Infarction in previous six months or troponin \>0.5