Covid19, Inhaled Nitric Oxide, Nitric Oxide, Pneumonia, Viral, Respiratory Disease, SARS-CoV Infection, Viral Pneumonia
Conditions
Keywords
Inhaled Nitric Oxide, iNO, Virus, Respiratory Disease, Viral Pneumonia, COVID-19, SARS-CoV-2
Brief summary
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
Interventions
DEVICELungFit™
Patients will receive inhalations of 150 ppm for 40 min 4 times a day, up to 7 days (maximum 28 treatments)
Sponsors
Beyond Air Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| incidence of Serious Adverse Events | 30 days | Clinical safety will be assessed by incidence of Serious Adverse Events (SAEs) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| fever resolution | Baseline to 30 days | Time to fever resolution |
| ICU admission | Baseline to 30 days | Number of patients requiring admission to ICU |
| Oxygen support | Baseline to 30 days | Time until patient no longer requires supportive oxygen |
| Stable room air saturation | Baseline to 30 days | b.d. Stable room air saturation of 93% and above or returning to baseline saturation, whichever is lower |
Countries
Israel
Outcome results
None listed