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

Sponsor
Beyond Air Inc. (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT04456088
Collaborator
(none)
0
3
5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Combination Product: 150 ppm Nitric Oxide delivered through LungFit Delivery System
  • Combination Product: 80 ppm Nitric Oxide delivered through LungFit Delivery System
Phase 2

Study Design

Study Type:
Interventional
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.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
Anticipated Study Start Date :
Jul 15, 2020
Anticipated Primary Completion Date :
Nov 15, 2020
Anticipated Study Completion Date :
Dec 15, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Time to deterioration [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 [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 [30 days after last inhalation treatment]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
22 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Beyond Air Inc.

Investigators

  • Study Director: Asher Tal, MD, Beyond Air

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Beyond Air Inc.
ClinicalTrials.gov Identifier:
NCT04456088
Other Study ID Numbers:
  • BAI_COV19_01_CAN
First Posted:
Jul 2, 2020
Last Update Posted:
Jan 22, 2021
Last Verified:
Jul 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 22, 2021