The purpose of this multi center, open label, randomized, study is to obtain information on the safety and efficacy of 150 ppm Nitric Oxide given in addition to the standard of care of patients with viral pneumonia
Device: LungFit™
Patients will receive inhalations of 150 ppm for 40 min 4 times a day, up to 7 days (maximum 28 treatments)
Inclusion Criteria:
- Patients (male and female) admitted to the hospital for clinical diagnosis of viral
pneumonia including COVID-19 patients that have a positive nasal swab.
- Age 18 to 80 years
- Female subjects must be willing to use medically acceptable contraception from
screening to Day 30 (acceptable forms of contraception: abstinence, hormonal birth
control, intrauterine device, or barrier method plus a spermicidal agent).
- Ability to understand and comply with study requirements.
- Signed informed consent by subject
Exclusion Criteria:
- Patients with pneumonia with two or more of the following:
1. WBC of more than 15,000
2. Lobar pneumonia
3. Pleural effusion
- Patients who are treated with or require high flow nasal cannula, CPAP, intubation,
mechanical ventilation, or tracheostomy
- Breastfeeding or pregnancy as evidenced by a positive pregnancy test.
- Subjects diagnosed with immunodeficiency, with history of congestive or unstable heart
disease, left ventricular dysfunction (LVEF <40%) or myocardial damage, severe
pulmonary hypertension and/or unstable hypertension
- Use of an investigational drug during the last 30 days prior enrollment
- Methemoglobin level >3% at screening
- Patients on chronic (over two weeks of treatment) systemic steroids (any formulation,
excluding Dexamethasone or Prednisone) within 30 days prior to enrollment.
- History of daily, continuous oxygen supplementation
- Patients with BMI greater than or equal to 40
- Patients with clinically significant anemia, e.g., Hb <10.0 and/or thrombocytopenia,
e.g., Platelets <75.
- Smokers who are unwilling to refrain from smoking during hospitalization
- Presence of a condition or abnormality that in the opinion of the Investigator would
compromise the safety of the subject or the quality of the data, e.g., known or
suspected thalassemia, sickle cell disease or other diseases associated with poor
oxygen carrying capacity.
- The subject is identified by the investigator as being unable or unwilling to perform
study procedures.
Shaare Zedek Medical Center
Jerusalem, Israel
Hasharon Medical Center
Petah Tikva, Israel
Rabin Medical Center
Petah Tikva, Israel
Asher Tal, Study Director
Beyond Air