Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Inhaled NO delivered using LungFitâ„¢ in addition to standard of care |
|
| Standard of care | No Intervention | Standard of care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LungFitâ„¢ | Device | Patients will receive inhalations of 150 ppm for 40 min 4 times a day, up to 7 days (maximum 28 treatments) |
|
| Measure | Description | Time Frame |
|---|---|---|
| incidence of Serious Adverse Events | Clinical safety will be assessed by incidence of Serious Adverse Events (SAEs) | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| fever resolution | Time to fever resolution | Baseline to 30 days |
| ICU admission | Number of patients requiring admission to ICU | Baseline to 30 days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Patients with pneumonia with two or more of the following:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Asher Tal | Beyond Air | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shaare Zedek Medical Center | Jerusalem | Israel | ||||
| Hasharon Medical Center |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D012120 | Respiration Disorders |
| D000086382 | COVID-19 |
| D045169 | Severe Acute Respiratory Syndrome |
| D014777 | Virus Diseases |
| ID | Term |
|---|---|
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Oxygen support | Time until patient no longer requires supportive oxygen | Baseline to 30 days |
| Stable room air saturation | b.d. Stable room air saturation of 93% and above or returning to baseline saturation, whichever is lower | Baseline to 30 days |
| Petah Tikva |
| Israel |
| Rabin Medical Center | Petah Tikva | Israel |
| D012140 |
| Respiratory Tract Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |