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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04456088
Recruitment Status : Withdrawn (Terminated (halted prematurely))
First Posted : July 2, 2020
Last Update Posted : January 22, 2021
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
COVID-19 SARS-CoV 2 Respiratory Disease Pneumonia, Viral Corona Virus Infection Combination Product: 150 ppm Nitric Oxide delivered through LungFit Delivery System Combination Product: 80 ppm Nitric Oxide delivered through LungFit Delivery System Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Inhaled NO for the Treatment of COVID-19 Caused by SARS-CoV-2
Estimated Study Start Date : July 15, 2020
Estimated Primary Completion Date : November 15, 2020
Estimated Study Completion Date : December 15, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Phase 1- Nitric oxide treatment- 80ppm Combination Product: 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.

Experimental: Phase 2- Group 1- Nitric oxide treatment- 150ppm 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.

No Intervention: Phase 2- Group 2- control
Standard of Care



Primary Outcome Measures :
  1. Time to deterioration [ Time Frame: 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 :
  1. Time to stable oxygen saturation [ Time Frame: up to 14 days ]
    Time to patient having stable oxygen saturation (SpO2) of greater than 92% for longer than 3 hr on room air


Other Outcome Measures:
  1. Treatment Emergent Adverse Events and SAEs [ Time Frame: 30 days after last inhalation treatment ]
    Treatment Emergent Adverse Events and SAEs - safety evaluation for 30 days after last inhalation treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04456088


Sponsors and Collaborators
Beyond Air Inc.
Investigators
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Study Director: Asher Tal, MD Beyond Air
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Responsible Party: Beyond Air Inc.
ClinicalTrials.gov Identifier: NCT04456088    
Other Study ID Numbers: BAI_COV19_01_CAN
First Posted: July 2, 2020    Key Record Dates
Last Update Posted: January 22, 2021
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronavirus Infections
Pneumonia, Viral
Pneumonia
Respiration Disorders
Respiratory Tract Diseases
Lung Diseases
Respiratory Tract Infections
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Gasotransmitters
Protective Agents