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

Primary Purpose

COVID-19, SARS-CoV 2, Respiratory Disease

Status

Withdrawn

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

150 ppm Nitric Oxide delivered through LungFit Delivery System

80 ppm Nitric Oxide delivered through LungFit Delivery System

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

22 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients (male and female) admitted to the hospital for COVID-19
Patients with oxygen saturation less than 93 % on room air
Shortness of breath, with symptom onset within the previous 8 days.
Ability to understand and comply with study requirements .
Signed informed consent by subject

Exclusion Criteria:

Patients who are treated with or require high flow nasal cannula, CPAP, intubation, mechanical ventilation, or tracheostomy
Diagnosis of acute respiratory distress syndrome
Breastfeeding or pregnancy as evidenced by a positive pregnancy test.
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
History of frequent epistaxis (>1 episode/month).
Significant hemoptysis during the last 30 days prior to enrollment
Methemoglobin level >3% at screening
Patients on systemic steroids (any formulation) within 30 days prior to enrollment.
History of daily, continuous oxygen supplementation
Patients with BMI greater than or equal to 36
Patient receiving drugs that have a contraindication with NO,
Patients with clinically significant anemia, e.g., Hb <100 g/L and thrombocytopenia, e.g., Platelets <75 thousand cells/mcL.
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.
The subject is identified by the investigator as being unable or unwilling to perform study procedures.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Arm Label

Phase 1- Nitric oxide treatment- 80ppm

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

Phase 2- Group 2- control

Arm Description

Standard of Care

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT04456088

First Posted

July 1, 2020

Last Updated

January 21, 2021

Sponsor

Beyond Air Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04456088

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Withdrawn

Why Stopped

Terminated (halted prematurely)

Study Start Date

July 15, 2020 (Anticipated)

Primary Completion Date

November 15, 2020 (Anticipated)

Study Completion Date

December 15, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Beyond Air Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

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)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Phase 1- Nitric oxide treatment- 80ppm

Arm Type

Experimental

Arm Title

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

Arm Type

Experimental

Arm Title

Phase 2- Group 2- control

Arm Type

No Intervention

Arm Description

Standard of Care

Intervention Type

Combination Product

Intervention Name(s)

150 ppm Nitric Oxide delivered through LungFit Delivery System

Intervention Description

Nitric Oxide delivered via LungFit system. Patients will receive inhalations of 150 ppm for 40 minutes 4 time per day plus standard supportive care.

Intervention Type

Combination Product

Intervention Name(s)

80 ppm Nitric Oxide delivered through LungFit Delivery System

Intervention Description

Nitric Oxide delivered via LungFit system. Patients will receive inhalations of 80 ppm for 40 minutes 4 time per day plus standard supportive care.

Primary Outcome Measure Information:

Title

Time to deterioration

Description

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

Time Frame

up to 14 days

Secondary Outcome Measure Information:

Title

Time to stable oxygen saturation

Description

Time to patient having stable oxygen saturation (SpO2) of greater than 92% for longer than 3 hr on room air

Time Frame

up to 14 days

Other Pre-specified Outcome Measures:

Title

Treatment Emergent Adverse Events and SAEs

Description

Treatment Emergent Adverse Events and SAEs - safety evaluation for 30 days after last inhalation treatment

Time Frame

30 days after last inhalation treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

22 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients (male and female) admitted to the hospital for COVID-19 Patients with oxygen saturation less than 93 % on room air Shortness of breath, with symptom onset within the previous 8 days. Ability to understand and comply with study requirements . Signed informed consent by subject Exclusion Criteria: Patients who are treated with or require high flow nasal cannula, CPAP, intubation, mechanical ventilation, or tracheostomy Diagnosis of acute respiratory distress syndrome Breastfeeding or pregnancy as evidenced by a positive pregnancy test. 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 History of frequent epistaxis (>1 episode/month). Significant hemoptysis during the last 30 days prior to enrollment Methemoglobin level >3% at screening Patients on systemic steroids (any formulation) within 30 days prior to enrollment. History of daily, continuous oxygen supplementation Patients with BMI greater than or equal to 36 Patient receiving drugs that have a contraindication with NO, Patients with clinically significant anemia, e.g., Hb <100 g/L and thrombocytopenia, e.g., Platelets <75 thousand cells/mcL. 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. The subject is identified by the investigator as being unable or unwilling to perform study procedures.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Asher Tal, MD

Organizational Affiliation

Beyond Air

Official's Role

Study Director

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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