New Study to Assess Effectiveness of Inhaled Nitric Oxide as Treatment for SARS in COVID-19 Patients

An investigator-initiated clinical study at Massachusetts General Hospital is evaluating the potential benefits of inhaled nitric oxide as a treatment for pulmonary complications in patients infected with COVID-19.

Mallinckrodt plc (Staines-upon-Thames, UK), a global biopharmaceutical company, is providing funding as well as INOmax (nitric oxide) gas, for inhalation, to facilitate the study titled “Inhaled Nitric Oxide Gas Therapy in Mechanically Ventilated Patients with Severe Acute Respiratory Syndrome in COVID-19.” Mallinckrodt, along with Novoteris LLC, a clinical stage medical device and pharmaceutical developer, has also received approval from Health Canada to begin a pilot trial of high-dose inhaled nitric oxide therapy to treat the COVID-19 infection and associated lung complications.

INOmax has been on the market in the US since 2000 and is indicated for the treatment of term and near-term neonates with hypoxic respiratory failure associated with pulmonary hypertension. More than 170 hospitals and health systems in the US have reported using INOmax as an experimental treatment for pulmonary complications of COVID-19 patients. However, the safety and efficacy of INOmax to treat COVID-19 infections and associated lung complications have not been established by the US Food and Drug Administration.

The current trial will enable formal data collection in a structured study of the efficacy and safety of inhaled nitric oxide in patients with pulmonary complications of COVID-19. The primary focus of the study is to assess the potential efficacy of inhaled nitric oxide to rapidly reverse hypoxemia (abnormally low oxygen levels in the blood) in patients with severe COVID-19 lung complications. Specifically, it will determine the difference in oxygenation in patients after 48 hours of treatment. Secondary objectives include evaluating the time it takes for patients who are breathing air to reach normoxia (normal oxygen levels in the blood) for at least 24 hours; the proportion of patients who achieve normoxia during the first 28 days after enrollment; and the patient survival rate at 28 days and 90 days, among other objectives.

“Patients around the world are in need of science-based therapies that can effectively fight this life-threatening disease, and Mallinckrodt is committed to assisting health providers and government agencies to research and identify possible solutions to help relieve this global crisis,” said Steven Romano, M.D., Executive Vice President and Chief Science Officer at Mallinckrodt. “We are extremely pleased to support Massachusetts General Hospital in these research efforts to potentially bring a new therapeutic option to physicians and patients who need it most.”