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

Sponsor

Bellerophon (Industry)

Overall Status

No longer available

CT.gov ID

NCT04358588

Collaborator

(none)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronavirus Infection COVID-19 Pneumonia, Viral	Drug: iNO (inhaled nitric oxide) delivered via the INOpulse Delivery System

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 Design

Study Type:

Expanded Access

Official Title:

Expanded Access: Pulsed, Inhaled Nitric Oxide (iNO) for the Treatment of Patients With Mild or Moderate Coronavirus Disease (COVID-19)

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 95 Years

Sexes Eligible for Study:

All

Inclusion Criteria:

Signed Informed Consent Form (and assent as appropriate) prior to the initiation of any study mandated procedures or assessments.
At least 18 years old
Patients with proven or high suspicion of SARS-CoV-2 infection and on supplemental oxygen ≤ 10 L/minute
Suspected or proven pneumonia on chest imaging
Female patients of childbearing potential must have a negative pre-treatment pregnancy test (serum or urine). All female patients should take adequate precaution to avoid pregnancy.
Willing and able to comply with treatment schedule and study procedures.

Exclusion Criteria:

Participating in any other clinical trial of an experimental treatment for COVID-19
Gas exchange and ventilation requiring the use of any continuous positive airway pressure (CPAP), or any system of Non Invasive Ventilation (NIV), with Positive End-Expiratory Pressure (PEEP) ≤ 10 cmH2O prior to initiation of iNO
Pregnancy, or positive pregnancy test in a pre-dose examination
Open tracheostomy
Clinical contra-indication, as deemed by the attending physician
Use of a nitric oxide donor agent such as nitroglycerin or drugs known to increase methemoglobin such as lidocaine, prilocaine, benzocaine or dapsone at screening
Known history or clinical evidence of heart failure, left ventricular dysfunction (LVEF < 40 %)
Patients reporting hemoptysis