On Apr. 20, 2020, Atossa Therapeutics announced that it had applied to the FDA for approval to commence a clinical study of its proprietary drug, AT-H201, in COVID-19 patients on mechanical ventilation. AT-H201 is a novel formulation of two pharmaceuticals previously approved by the FDA for other diseases. The goal of the clinical trial, called the HOPE Study, was to demonstrate improved lung function and reduce the amount of time that COVID-19 patients are on ventilators.

“One of the most tragic clinical features of the COVID-19 pandemic is the very high mortality rate for patients who require mechanical ventilation,” stated Dr. Steven Quay, Atossa’s President and CEO. “It is our hope that AT-H201 can have an impact in this clinical setting, both to save lives and to get patients off of the ventilator. Although there are over 100 clinical trials for COVID-19 being conducted in the United States, this is the first trial that I am aware of that is testing nebulized pharmaceuticals for patients on mechanical ventilation. Atossa looks forward to working on this important medical need and to reduce the death toll of COVID-19.”

The HOPE Study will assess the safety and efficacy of AT-H201 administered via inhalation in COVID-19 patients on mechanical ventilation support. Subject to FDA and IRB input, the study is currently designed as follows: At least thirty-nine patients will be enrolled in the active treatment group and compared to the outcome of 66 patients in a matched retrospective control group. Patients will be dosed with AT-H201 each day in addition to the standard of care while on mechanical ventilation for up to seven days and will be followed up throughout hospitalization and for 28 days after discharge. The primary objectives are to determine the number of ventilator-free days after patients are removed from ventilators following the initial airway intervention; oxygenation levels; and survival rates. Secondary efficacy endpoints include a variety of lung function parameters and time in ICU. Secondary safety endpoints include markers of coagulation.