Clinical trial NCT04456088: 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
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: COVID-19
SARS-CoV 2
Respiratory Disease
Pneumonia, Viral
Corona Virus Infection
Lead sponsor: Beyond Air Inc.
Sponsor class: INDUSTRY
First posted: 2020-07-02
Enrollment: 0
Sex: ALL
Minimum age (years): 22
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Time to deterioration
timeFrame: up to 14 days
Secondary outcomes:
measure: Time to stable oxygen saturation
timeFrame: up to 14 days
Other outcomes:
measure: Treatment Emergent Adverse Events and SAEs
timeFrame: 30 days after last inhalation treatment
Locations:
Study officials:
affiliation: Beyond Air
name: Asher Tal, MD
role: STUDY_DIRECTOR
References: