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

• ClinicalTrials.gov Identifier: NCT04456088
• Recruitment Status: Withdrawn
• First Posted: July 2, 2020
• Last Update Posted: January 22, 2021
• Sponsor: Beyond Air Inc.
• Information provided by (Responsible Party): Beyond Air Inc.

Study Description

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.

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 Design

• 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

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. 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

Other Outcome Measures:

1. 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

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Sponsors and Collaborators

Beyond Air Inc.

Investigators

• Study Director: Asher Tal, MD; Beyond Air

More Information

• Responsible Party: Beyond Air Inc.
• ClinicalTrials.gov Identifier: NCT04456088
• Other Study ID Numbers: BAI_COV19_01_CAN
• First Posted: July 2, 2020
• 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

Additional relevant MeSH terms:

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