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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04456088
• Other study ID #: BAI_COV19_01_CAN
• Status: Withdrawn
• Phase: Phase 2
• Start date: July 15, 2020
• Est. completion date: December 15, 2020

Study information

• Verified date: July 2020
• Source: Beyond Air Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 15, 2020
• Est. primary completion date: November 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Corona Virus Infection
• Coronavirus Infections
• COVID-19
• Pneumonia
• Pneumonia, Viral
• Respiration Disorders
• Respiratory Disease
• Respiratory Tract Diseases
• SARS-CoV 2
• Severe Acute Respiratory Syndrome

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Beyond Air Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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