Inhaled ZYESAMI™ (Aviptadil Acetate) for the Treatment of Severe COVID-19

Stopped early · Phase 2/Phase 3 · Has a placebo group

Conditions studied: SARS-CoV 2, COVID, ARDS, ALI, Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS), Dyspnea

In brief

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.

Key facts

Study ID

NCT04360096

Run by

APR Applied Pharma Research s.a.

People needed

144

Starts

2021-02-15

Expected to finish

2021-12-31

Last updated by the study team

2023-02-03

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Severe COVID-19 , as defined by clinical signs indicative of severe systemic illness with COVID-19, being given oxygenation and meeting
• ONE of the following:
• Respiratory rate ≥ 30 per minute Heart rate ≥ 125 per minute SpO2 ≤ 93% on room air at sea level PaO2/FiO2 < 300 mmHg or SpO2/FiO2 < 315 mmHg
• 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

You may not qualify if…

• 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
• Recent history of venous thrombotic events (PE / DVT) within the last 3 months.
• New diagnosis of atrial fibrillation within the last 3 months. Acceptable if greater than 3 months and well controlled in the opinion of the investigator
• Watery diarrhea requiring replacement of 1 liter or more of iv fluids and electrolytes
• Pregnancy

Where it is running

• St. Jude Medical Center — Fullerton, California, United States
• University of California - Irvine — Irvine, California, United States
• University of Miami Leonard M. Miller School of Medicine (UMMSM) — Miami, Florida, United States
• Advent Health Research Institute — Orlando, Florida, United States
• Northwestern Medical Group — Winfield, Illinois, United States
• University of Louisville Hospital — Louisville, Kentucky, United States
• Great Plains Health — North Platte, Nebraska, United States
• University Medical Center — Las Vegas, Nevada, United States
• Holy Name Medical Center — Teaneck, New Jersey, United States
• Kettering Health Network — Kettering, Ohio, United States
• Doylestown Hospital — Doylestown, Pennsylvania, United States
• Self Regional Healthcare — Greenwood, South Carolina, United States
• University of Texas San Antonio Medical Arts and Research Center — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.