An expanded access record providing iNO (inhaled nitric oxide) delivered via the INOpulse Delivery System in Coronavirus Infection, COVID-19 and Pneumonia, Viral, sponsored by Bellerophon. No longer available. Open to participants aged 18 Years to 95 Years. Per ClinicalTrials.gov, last updated 2023-02-21.
Sponsored by Bellerophon · Expanded access
The search for novel therapies to address the ongoing coronavirus (COVID-19) pandemic is ongoing. No proven therapies have been identified to prevent progression of the virus. Preliminary data suggest that inhaled nitric oxide (iNO) could have benefit in preventing viral progression and reducing reliance on supplemental oxygen and ventilator support.
Expanded access allows for iNO to be delivered via the portable INOpulse delivery system for the treatment of COVID-19.
NO is a naturally produced molecule that is critical to the immune response to defend against pathogens and infections. In vitro studies have shown that NO inhibits the replication of severe acute respiratory syndrome-related coronavirus (SARS-CoV) and improves survival for cells infected with SARS-CoV. Additionally, in a clinical study of patients infected with SARS-CoV, iNO demonstrated improvements in arterial oxygenation, a reduction in ventilation support and an improvement in lung infiltrates observed on chest radiography. Based on the genetic similarities between the two coronaviruses, the data in SARS-CoV support the potential for iNO to provide meaningful benefit for patients infected with COVID-19.
The clinical spectrum of the COVID-19 infection ranges from mild signs of upper respiratory tract infection to severe pneumonia and death. Preventing disease progression in patients with mild or moderate disease would improve morbidity/mortality and significantly reduce the impact on limited healthcare resources.
Expanded access allows for iNO to be delivered via the INOpulse delivery system for the treatment of COVID-19. INOpulse technology provides targeted pulsatile delivery of iNO via portable INOpulse delivery system.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
Browse COVID-19 studies →Bellerophon is the lead sponsor of 6 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Patients will be treated by means of an INOpulse device and cannula. The active study drug, nitric oxide for inhalation (iNO), will be provided in size 0.074 liter aluminum cartridge at a concentration of 6.0 mg/L (4880 ppm).
No study locations are listed for this record.
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