The purpose of this open label, randomized, study is to obtain information on the safety and efficacy of 80 ppm Nitric Oxide given in addition to the standard of care of patients with COVID-19 caused by SARS-CoV-2.
Nitric Oxide (NO) is a small endogenously produced molecule recognized to play a critical
role in the function of several body systems including the vasodilatation of smooth muscle,
neurotransmission, regulation of wound healing and inhibition of pathogens. In-vitro studies
have shown that NO inhibits the replication cycle of the severe acute respiratory syndrome
coronavirus (SARS CoV) in vitro. The suggested mechanisms of actions of NO on SARS are an
effect on the fusion between the S protein and its cognate receptor, ACE2, and reduction in
viral RNA production in the early steps of viral replication. The primary aim of this
feasibility study is to investigate the safety of intermittent NO, delivered via inhalation,
in hospitalized patients with COVID-19. The primary endpoint in the study will be time to
deterioration of respiratory symptoms determined by escalation to either non-invasive
ventilation (NIV), high-flow nasal cannula (HFNC), or intubation.
Device: Nitric Oxide delivered via LungFit™ system
Patients will receive inhalations of 80 ppm for 40 min 4 times a day
Inclusion Criteria:
- Enrollment within 24 hours of hospital admission of patients diagnosed with COVID-19
- Patients with oxygen saturation less than 93 % on room air
- Shortness of breath, with symptom onset within the previous 8 days.
- Female subjects of childbearing potential should take adequate measures to avoid
pregnancy
- Signed informed consent by the subject
Exclusion Criteria:
- Patients who are treated with or require high flow nasal cannula, CPAP, intubation,
mechanical ventilation, or tracheostomy
- Diagnosis of acute respiratory distress syndrome
- Subjects diagnosed with immunodeficiency, with history of congestive or unstable heart
disease, left ventricular dysfunction or myocardial damage, severe pulmonary
hypertension and/or unstable hypertension
- Patients receiving drugs that have contraindications with NO.
- Breastfeeding or pregnancy as evidenced by a positive pregnancy test.
- Patients with active pulmonary malignancy or lung transplant
- Patients with a history of frequent epistaxis or significant hemoptysis
Baptist Health Center for Clinical Research
Little Rock, Arkansas, United States
Ashik Tal, MD, Study Director
Beyond Air