The Food and Drug Administration has cleared the initiation of a phase 3 trial evaluating INOpulse® inhaled nitric oxide (iNO) therapy (Bellerophon Therapeutics) in patients with coronavirus disease 2019 (COVID-19).

Previous research has suggested that the use of nitric oxide could potentially prevent viral replication, as well as improve arterial oxygenation and reduce the need for ventilation support in patients with severe acute respiratory syndrome coronavirus (SARS-CoV). 

The randomized, placebo-controlled PULSE-CVD19-001 trial is expected to include up to 500 patients and will investigate the safety and efficacy of INOpulse in patients with COVID-19 who need supplemental oxygen but before their disease has progressed to requiring mechanical ventilation. The primary end point of the study will be an assessment of the proportion of patients who progress to respiratory failure or death.

In addition to the phase 3 trial, INOpulse therapy is currently being investigated under an emergency expanded access program, which to date, has included 50 patients with COVID-19. “We have been encouraged by the improvements in patients with COVID-19 treated with INOpulse, reinforcing the potential for our proprietary therapy to improve oxygenation in patients and halt the progression of the virus,” said Fabian Tenenbaum, Chief Executive Officer at Bellerophon Therapeutics.

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The INOpulse delivery system is a portable device designed to deliver nitric oxide via a proprietary triple-lumen nasal cannula directly to the well-ventilated parts of the lung matching ventilation to perfusion (V/Q matching) and improving oxygenation.

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