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

Phase 2

Withdrawn

• Conditions: SARS-CoV 2; Corona Virus Infection; COVID-19; Pneumonia, Viral; Respiratory Disease
• Interventions: Combination Product: 150 ppm Nitric Oxide delivered through LungFit Delivery System; Combination Product: 80 ppm Nitric Oxide delivered through LungFit Delivery System

• Registration Number: NCT04456088
• Lead Sponsor: Beyond Air Inc.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-07
• Study First Submitted: 2020-07-01
• Study First Submitted QC: 2020-07-01
• Study First Posted: 2020-07-02
• Study Start: 2020-07-15
• Primary Completion: 2020-11-15
• Study Completion: 2020-12-15
• Last Update Submitted: 2021-01-21
• Last Update Posted: 2021-01-22

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Phase 2- Group 1- Nitric oxide treatment- 150ppm	150 ppm Nitric Oxide delivered through LungFit Delivery System	-
Phase 1- Nitric oxide treatment- 80ppm	80 ppm Nitric Oxide delivered through LungFit Delivery System	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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