On Apr. 27, 2020, Atossa Therapeutics announced that it had contracted with NYC Health + Hospitals/Metropolitan in New York City to conduct the NY HOPE Study of Atossa’s proprietary combination drug therapy called AT-H201. The NY HOPE Study evaluated AT-H201 in COVID-19 patients on ventilators with the goal of reducing the amount of time on ventilators.

The NY 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: Thirty-nine patients will be enrolled in the active treatment group and compared to the outcomes 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 during 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 and system function. The NY HOPE Study is currently pending IRB approval and will not commence without IRB and all necessary regulatory approvals, including FDA. Atossa has filed comprehensive provisional patent applications related to AT-H201.