Mallinckrodt has launched a retrospective chart review study which will collect real-world data on the use of INOmax (nitric oxide) gas for inhalation therapy in patients with respiratory complications associated with COVID-19.
INOmax is already indicated for the treatment of term and near-term neonates with hypoxic respiratory failure associated with pulmonary hypertension.
Mallinckrodt will partner with Pharmerit to collect data from around 200 hospitalised adult patients with a confirmed COVID-19 diagnosis, who were treated with INOmax for pulmonary complications associated with COVID-19 for at least 24 hours between 1 January 2020 and 31 July 2020.
The study will aim to describe the disease course of patients initiating INOmax for management of COVID-19 symptoms, as well as assess the clinical outcomes of patients who received INOmax early versus late.
Other objectives of the study include describing the demographic and clinical characteristics of patients hospitalised with COVID-19 and treated with INOmax.
In addition, Mallinckrodt’s stud y will aim to describe treatments and procedures, and during the initial hospitalisation, and survival at 30 days post-discharge in patients who are treated with INOmax.
“We hope this retrospective chart review will help to further extend our understanding of the use of inhaled nitric oxide,” said Steven Romano, executive vice president and chief scientific officer at Mallinckrodt.