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

NCT04456088 | Withdrawn Phase 2

• 1 other identifier: BAI_COV19_01_CAN
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Time to stable oxygen saturation

  up to 14 days

Other Outcomes (1)

• Treatment Emergent Adverse Events and SAEs

  30 days after last inhalation treatment

Study Arms (3)

Phase 1- Nitric oxide treatment- 80ppm

EXPERIMENTAL

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

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

EXPERIMENTAL

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

Phase 2- Group 2- control

NO INTERVENTION

Standard of Care

Interventions

150 ppm Nitric Oxide delivered through LungFit Delivery System COMBINATION_PRODUCT

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

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

80 ppm Nitric Oxide delivered through LungFit Delivery System COMBINATION_PRODUCT

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

Phase 1- Nitric oxide treatment- 80ppm

Eligibility Criteria

• Age: 22 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beyond Air Inc.: lead

MeSH Terms

Conditions

COVID-19; Respiration Disorders; Pneumonia, Viral; Coronavirus Infections

Condition Hierarchy (Ancestors)

Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Asher Tal, MD

  Beyond Air

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 1, 2020
• First Posted: July 2, 2020
• Study Start: July 15, 2020
• Primary Completion: November 15, 2020
• Study Completion: December 15, 2020
• Last Updated: January 22, 2021

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share