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Expanded Access to INOpulse® Inhaled Nitric Oxide Therapy for Patients with Confirmed or Suspected COVID-19 Who Require Supplemental Oxygen

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Overview

This study will examine the use of the Bellerophon INOpulse® system to deliver calibrated doses of inhaled nitric oxide (iNO) as a vasodilator and suppressor of viral replication in spontaneously breathing COVID-19 patients on supplemental oxygen, with the ultimate goal of slowing or preventing disease progression. This is an investigational treatment made available through the FDA’s Emergency Expanded Access program.
 
INOpulse® is currently being evaluated to treat chronic pulmonary hypertension associated with pulmonary fibrosis and other respiratory related diseases. Access to INOpulse® was expanded because NO may also inhibit replication of the SARS-CoV-2 virus and may improve survival of infected cells in in vitro studies. This INOpulse® expanded access study is recommended for patients with a confirmed diagnosis or strong clinical suspicion of COVID-19 who are on supplemental oxygen < 10 L/min and do not require assisted ventilation.

The primary objective of this study is to evaluate disease progression in spontaneously breathing COVID-19 patients receiving INOpulse® treatment. Enrolled patients will receive pulsed, inhaled nitric oxide 125 mcg/kg IBW/hr (iNO125) for at least 8 hours and up to 24 hours daily for 3 to 14 days or until resolution or discharge.

This study is NOT appropriate for COVID-19 patients with poor left ventricular function (LVEF < 40%) and/or hemodynamic instability.

For More Information

This is NOT a clinical trial. Rather, it is an investigational treatment made available through the FDA's Emergency Expanded Access program. For more information, please call 215-707-1359 or email breathe@tuhs.temple.edu.