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

Launched by BELLEROPHON · Apr 22, 2020

Keywords

ClinConnect Summary

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 coronaviruse...

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Eligibility criteria

• Inclusion Criteria:
• • 1. Signed Informed Consent Form (and assent as appropriate) prior to the initiation of any study mandated procedures or assessments.
• • 2. At least 18 years old
• • 3. Patients with proven or high suspicion of SARS-CoV-2 infection and on supplemental oxygen ≤ 10 L/minute
• • 4. Suspected or proven pneumonia on chest imaging
• • 5. 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.
• • 6. Willing and able to comply with treatment schedule and study procedures.
• Exclusion Criteria:
• • 1. Participating in any other clinical trial of an experimental treatment for COVID-19
• • 2. 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
• • 3. Pregnancy, or positive pregnancy test in a pre-dose examination
• • 4. Open tracheostomy
• • 5. Clinical contra-indication, as deemed by the attending physician
• • 6. 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
• • 7. Known history or clinical evidence of heart failure, left ventricular dysfunction (LVEF \< 40 %)
• • 8. Patients reporting hemoptysis