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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: COVID-19; Pneumonia, Viral; SARS-CoV 2; Corona Virus Infection; Respiratory Disease
• Intervention / Treatment: Combination product: 80 ppm Nitric Oxide delivered through LungFit Delivery System; Combination product: 150 ppm Nitric Oxide delivered through LungFit Delivery System

• Study Type: Interventional
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Emergent Adverse Events and SAEs	Treatment Emergent Adverse Events and SAEs - safety evaluation for 30 days after last inhalation treatment	30 days after last inhalation treatment

Collaborators and Investigators

• Sponsor: Beyond Air Inc.
• Investigators: Study Director: Asher Tal, MD, Beyond Air

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 15, 2020
• Primary Completion (ANTICIPATED): November 15, 2020
• Study Completion (ANTICIPATED): December 15, 2020

Study Registration Dates

• First Submitted: July 1, 2020
• First Submitted That Met QC Criteria: July 1, 2020
• First Posted (ACTUAL): July 2, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 22, 2021
• Last Update Submitted That Met QC Criteria: January 21, 2021
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Pneumonia; Lung Diseases; COVID-19; Coronavirus Infections; Pneumonia, Viral; Respiration Disorders; Respiratory Tract Diseases; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Protective Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Antioxidants; Free Radical Scavengers; Endothelium-Dependent Relaxing Factors; Gasotransmitters; Nitric Oxide
• Other Study ID Numbers: BAI_COV19_01_CAN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No