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

Beyond Air

Status and phase: Withdrawn; Phase 2

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

Treatments: Combination Product: 150 ppm Nitric Oxide delivered through LungFit Delivery System; Combination Product: 80 ppm Nitric Oxide delivered through LungFit Delivery System

Study type: Interventional

Funder types: Industry

Identifiers

NCT04456088

BAI_COV19_01_CAN

Details and patient eligibility

About

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.

Sex: All

Ages: 22 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 3 patient groups

Phase 1- Nitric oxide treatment- 80ppm

Experimental group

Treatment:

Combination Product: 80 ppm Nitric Oxide delivered through LungFit Delivery System

Phase 2- Group 1- Nitric oxide treatment- 150ppm

Experimental group

Treatment:

Combination Product: 150 ppm Nitric Oxide delivered through LungFit Delivery System

Phase 2- Group 2- control

No Intervention group

Description:

Standard of Care