Corona Virus Infection, COVID-19, Pneumonia, Viral, Respiratory Disease, SARS-CoV 2
Conditions
Brief summary
The purpose of this open label, 2-phase, study is to obtain information on the safety of 80 ppm and the safety and efficacy of 150 ppm Nitric Oxide given in addition to the standard of care of patients with COVID-19 caused by SARS-CoV-2.
Interventions
COMBINATION_PRODUCT150 ppm Nitric Oxide delivered through LungFit Delivery System
Nitric Oxide delivered via LungFit system. Patients will receive inhalations of 150 ppm for 40 minutes 4 time per day plus standard supportive care.
COMBINATION_PRODUCT80 ppm Nitric Oxide delivered through LungFit Delivery System
Nitric Oxide delivered via LungFit system. Patients will receive inhalations of 80 ppm for 40 minutes 4 time per day plus standard supportive care.
Sponsors
Beyond Air Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a two phase study. The first 10 subjects will be treated with 80ppm NO; The remaining 40 subjects will be randomized in 1:1 ratio with subjects receiving 150 NO+SST or the SST alone.
Eligibility
Sex/Gender
ALL
Age
22 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Patients (male and female) admitted to the hospital for COVID-19 2. Patients with oxygen saturation less than 93 % on room air 3. Shortness of breath, with symptom onset within the previous 8 days. 4. Ability to understand and comply with study requirements . 5. Signed informed consent by subject
Exclusion criteria
1. Patients who are treated with or require high flow nasal cannula, CPAP, intubation, mechanical ventilation, or tracheostomy 2. Diagnosis of acute respiratory distress syndrome 3. Breastfeeding or pregnancy as evidenced by a positive pregnancy test. 4. 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 5. History of frequent epistaxis (\>1 episode/month). 6. Significant hemoptysis during the last 30 days prior to enrollment 7. Methemoglobin level \>3% at screening 8. Patients on systemic steroids (any formulation) within 30 days prior to enrollment. 9. History of daily, continuous oxygen supplementation 10. Patients with BMI greater than or equal to 36 11. Patient receiving drugs that have a contraindication with NO, 12. Patients with clinically significant anemia, e.g., Hb \<100 g/L and thrombocytopenia, e.g., Platelets \<75 thousand cells/mcL. 13. 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. 14. The subject is identified by the investigator as being unable or unwilling to perform study procedures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to deterioration | up to 14 days | Time to deterioration as measured by any one of the following: * need for non-invasive ventilation * need for high flow nasal cannula (HFNC) or * need for intubation * Death from any cause |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to stable oxygen saturation | up to 14 days | Time to patient having stable oxygen saturation (SpO2) of greater than 92% for longer than 3 hr on room air |
Other
| Measure | Time frame | Description |
|---|---|---|
| Treatment Emergent Adverse Events and SAEs | 30 days after last inhalation treatment | Treatment Emergent Adverse Events and SAEs - safety evaluation for 30 days after last inhalation treatment |
Outcome results
None listed