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Pulsed Inhaled Nitric Oxide for the Treatment of Patients With Mild or Moderate COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04358588
Expanded Access Status : No longer available
First Posted : April 24, 2020
Last Update Posted : June 12, 2020
Sponsor:
Information provided by (Responsible Party):
Bellerophon

Tracking Information
First Submitted Date April 21, 2020
First Posted Date April 24, 2020
Last Update Posted Date June 12, 2020
 
Descriptive Information
Brief Title Pulsed Inhaled Nitric Oxide for the Treatment of Patients With Mild or Moderate COVID-19
Brief Summary

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.

Detailed Description

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.

Study Type Expanded Access
Expanded Access Type Intermediate-size Population
Intervention Drug: iNO (inhaled nitric oxide) delivered via the INOpulse Delivery System
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).
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Expanded Access Status No longer available
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT04358588
Responsible Party Bellerophon
Study Sponsor Bellerophon
Collaborators Not Provided
Investigators
Study Director: Hunter Gilles, MD Acting Chief Medical Officer
PRS Account Bellerophon
Verification Date June 2020