Inhaled NO for the Treatment of COVID-19 Caused by SARS-CoV-2 (CANADA Trial)
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ClinicalTrials.gov Identifier: NCT04456088 |
Recruitment Status :
Withdrawn
(Terminated (halted prematurely))
First Posted : July 2, 2020
Last Update Posted : January 22, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
COVID-19 SARS-CoV 2 Respiratory Disease Pneumonia, Viral Corona Virus Infection | Combination Product: 150 ppm Nitric Oxide delivered through LungFit Delivery System Combination Product: 80 ppm Nitric Oxide delivered through LungFit Delivery System | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
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. |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Inhaled NO for the Treatment of COVID-19 Caused by SARS-CoV-2 |
Estimated Study Start Date : | July 15, 2020 |
Estimated Primary Completion Date : | November 15, 2020 |
Estimated Study Completion Date : | December 15, 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: Phase 1- Nitric oxide treatment- 80ppm |
Combination Product: 80 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. |
Experimental: Phase 2- Group 1- Nitric oxide treatment- 150ppm |
Combination Product: 150 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. |
No Intervention: Phase 2- Group 2- control
Standard of Care
|
- Time to deterioration [ Time Frame: 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
- Time to stable oxygen saturation [ Time Frame: up to 14 days ]Time to patient having stable oxygen saturation (SpO2) of greater than 92% for longer than 3 hr on room air
- Treatment Emergent Adverse Events and SAEs [ Time Frame: 30 days after last inhalation treatment ]Treatment Emergent Adverse Events and SAEs - safety evaluation for 30 days after last inhalation treatment

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Ages Eligible for Study: | 22 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04456088
Study Director: | Asher Tal, MD | Beyond Air |
Responsible Party: | Beyond Air Inc. |
ClinicalTrials.gov Identifier: | NCT04456088 |
Other Study ID Numbers: |
BAI_COV19_01_CAN |
First Posted: | July 2, 2020 Key Record Dates |
Last Update Posted: | January 22, 2021 |
Last Verified: | July 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
COVID-19 Coronavirus Infections Pneumonia, Viral Respiration Disorders Respiratory Tract Diseases Respiratory Tract Infections Infections Pneumonia Virus Diseases Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Nitric Oxide |
Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents Free Radical Scavengers Antioxidants Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Endothelium-Dependent Relaxing Factors Vasodilator Agents Gasotransmitters Protective Agents |