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May 1, 2020

Mallinckrodt to fund nitric oxide therapy trial in Covid-19 patients

Mallinckrodt has agreed to fund a clinical trial conducted by US researchers to assess the use of its inhaled nitric oxide therapy, INOmax, to treat lung complications in Covid-19 patients.

Mallinckrodt has agreed to fund a clinical trial conducted by US researchers to assess the use of its inhaled nitric oxide therapy, INOmax, to treat lung complications in Covid-19 patients.

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The company would offer funding support, as well as INOmax, for the investigator-initiated trial at Massachusetts General Hospital.

The primary objective of the study is the potential efficacy of inhaled nitric oxide in reversing abnormally low oxygen levels in the blood of Covid-19 patients with severe lung complications.

The trial aims to track the difference in oxygenation following 48 hours of treatment.

Secondary objectives include the time taken for reaching normal oxygen levels in the blood for at least 24 hours and the proportion of patients achieving normal levels during the initial 28 days after enrolment.

The trial will also monitor the patient survival rate at 28 days and 90 days, among other objectives.

Mallinckrodt noted that more than 170 hospitals in the US have reported using INOmax to potentially treat lung complications in Covid-19 patients.

Since 2000, INOmax has been available in the US to treat term and near-term neonates with hypoxic respiratory failure caused by pulmonary hypertension.

Massachusetts General Hospital respiratory care medical director Lorenzo Berra 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.

“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.”

Last month, Mallinckrodt secured approval from Canada’s health regulator to conduct a clinical study in partnership with Novoteris.

The Canadian trial will asses a high dose of nitric oxide therapy for Covid-19 infection and related lung complications. The companies expect to start enrolment in the coming days.

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