Massachusetts Hospital to Assess Mallinckrodt’s Nitric Oxide Treatment for COVID-19

Mallinckrodt and Massachusetts General Hospital teamed up to evaluate the potential benefits of inhaled nitric oxide as a treatment for pulmonary complications in patients infected with COVID-19.

The partnership will assess the benefit of INOmax (nitric oxide) gas in mechanically ventilated patients who have Severe Acute Respiratory Syndrome caused by COVID-19. The primary focus of the study is to assess the potential efficacy of inhaled nitric oxide to rapidly reverse hypoxemia, which is abnormally low oxygen levels in the blood, in patients with severe COVID-19 lung complications. Specifically, Mallinckrodt said the study will focus on improvement in oxygenation in patients after 48 hours of treatment. Secondary endpoints include evaluating the time it takes for patients who are breathing air to reach normal oxygen levels in the blood (normaxia) for at least 24 hours, as well as the proportion of patients who achieve normoxia during the first 28 days after enrollment. Also, the study will look at patient survival rate at 28 days and 90 days, Mallinckrodt said.

“Data suggest that inhaled nitric oxide may have an important role in helping patients with acute respiratory distress syndrome (ARDS) to achieve normal oxygen levels in the blood,” Lorenzo Berra, Medical Director of Respiratory Care at Massachusetts General Hospital said in a statement. “The trial we are conducting will help us gain critical insights into the potential effectiveness of INOmax in treating ARDS in critically ill COVID-19 patients.”

More than 170 hospitals and health systems in the U.S. have reported using INOmax as an experimental treatment for pulmonary complications of COVID-19 patients, Mallinckrodt said in its announcement.

Mallinckrodt Chief Science Officer Steven Romano said the company is committed to working with the scientific community to research and identify possible solutions to COVID-19, such as INOmax, which has been on the market in the U.S. since 2000 and is indicated for the treatment of term and near-term neonates with hypoxic respiratory failure associated with pulmonary hypertension.

“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,” Romano said in a statement.

Mallinckrodt’s INOmax isn’t the only nitric oxide therapy being assessed against COVID-19. In April, New Jersey-based Bellerophon Therapeutics submitted an Investigational New Drug Application to the FDA to study the INOpulse inhaled nitric oxide system for the treatment of patients infected with COVID-19. INOpulse is the only therapy to deliver targeted nitric oxide by autonomously adjusting to the patient’s breathing pattern to ensure accurate and consistent drug delivery into the airways, the company said. The IND submission follows an agreement by the FDA to allow treatment with INOpulse for COVID-19 patients under an emergency expanded access program.

The partnership with Massachusetts General Hospital came one month after Mallinckrodt and Novoteris LLC received the green light from Canada Health to being a pilot trial of high-dose inhaled nitric oxide therapy to treat the COVID-19 infection and associated lung complications.