Inhaled NO for the Treatment of COVID-19 Caused by SARS-CoV-2 (CANADA Trial)

Study Overview
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Brief Summary
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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.

Official Title
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Inhaled NO for the Treatment of COVID-19 Caused by SARS-CoV-2

Conditions
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COVID-19, SARS-CoV 2, Respiratory Disease, Pneumonia, Viral, Corona Virus Infection

Intervention / Treatment
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* Combination Product: 150 ppm Nitric Oxide delivered through LungFit Delivery System
* Combination Product: 80 ppm Nitric Oxide delivered through LungFit Delivery System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients (male and female) admitted to the hospital for COVID-19 Patients with oxygen saturation less than 93 % on room air Shortness of breath, with symptom onset within the previous 8 days. Ability to understand and comply with study requirements . Signed informed consent by 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 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 History of frequent epistaxis (>1 episode/month). Significant hemoptysis during the last 30 days prior to enrollment Methemoglobin level >3% at screening Patients on systemic steroids (any formulation) within 30 days prior to enrollment. History of daily, continuous oxygen supplementation Patients with BMI greater than or equal to 36 Patient receiving drugs that have a contraindication with NO, Patients with clinically significant anemia, e.g., Hb <100 g/L and thrombocytopenia, e.g., Platelets <75 thousand cells/mcL. 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.

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Phase 1- Nitric oxide treatment- 80ppm<br> | Combination Product: 80 ppm Nitric Oxide delivered through LungFit Delivery System<br>* Nitric Oxide delivered via LungFit system. Patients will receive inhalations of 80 ppm for 40 minutes 4 time per day plus standard supportive care.<br>|
| Experimental: Phase 2- Group 1- Nitric oxide treatment- 150ppm<br> | Combination Product: 150 ppm Nitric Oxide delivered through LungFit Delivery System<br>* Nitric Oxide delivered via LungFit system. Patients will receive inhalations of 150 ppm for 40 minutes 4 time per day plus standard supportive care.<br>|
| No Intervention: Phase 2- Group 2- control<br>Standard of Care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to deterioration | 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 | up to 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to stable oxygen saturation | Time to patient having stable oxygen saturation (SpO2) of greater than 92% for longer than 3 hr on room air | up to 14 days |