COVID-19Phase 2NCT04456088
Inhaled NO for the Treatment of COVID-19 Caused by SARS-CoV-2 (CANADA Trial)
A Phase 2 study testing 150 ppm Nitric Oxide delivered through LungFit Delivery System and 80 ppm Nitric Oxide delivered through LungFit Delivery System in people with COVID-19 and SARS-CoV 2, run by Beyond Air Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 75 years
- Conditions the study is for
- COVID-19, SARS-CoV 2, Respiratory Disease
- What is being tested?
- 150 ppm Nitric Oxide delivered through LungFit Delivery System and 80 ppm Nitric Oxide delivered through LungFit Delivery System
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2020to 15 Dec 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
About this study
Official title: Inhaled NO for the Treatment of COVID-19 Caused by SARS-CoV-2
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.
- Being tested
- 150 ppm Nitric Oxide delivered through LungFit Delivery System, 80 ppm Nitric Oxide delivered through LungFit Delivery System
- Medical subject headings
- COVID-19, Respiration Disorders, Pneumonia, Viral, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
150 ppm Nitric Oxide delivered through LungFit Delivery SystemCombination 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.
80 ppm Nitric Oxide delivered through LungFit Delivery SystemCombination 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.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1- Nitric oxide treatment- 80ppm | Experimental | Not described Receives: Combination Product: 80 ppm Nitric Oxide delivered through LungFit Delivery System |
| Phase 2- Group 1- Nitric oxide treatment- 150ppm | Experimental | Not described Receives: Combination Product: 150 ppm Nitric Oxide delivered through LungFit Delivery System |
| Phase 2- Group 2- control | No intervention | Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 14 days
Secondary outcomes (1)
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
Measured: up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2020
- Study start15 Jul 2020 (estimated)
- Primary completion15 Nov 2020 (estimated)
- Study completion15 Dec 2020 (estimated)
Why it stopped: Terminated (halted prematurely)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beyond Air Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Asher Tal, MD, Study director, Beyond Air
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04456088
- Sponsor's protocol ID
- BAI_COV19_01_CAN
- Status last verified
- Jul 2020
- First submitted
- 1 Jul 2020
- Last updated
- 22 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inhaled NO for the Treatment of COVID-19 Caused by SARS-CoV-2
- ClinicalTrials.gov ID
- NCT04456088
- Acronym / sponsor ID
- BAI_COV19_01_CAN
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Terminated (halted prematurely)
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Beyond Air Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Jul 2020 (estimated)
- Primary completion
- 15 Nov 2020 (estimated)
- Study completion
- 15 Dec 2020 (estimated)
- First posted
- 2 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 22 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 150 ppm Nitric Oxide delivered through LungFit Delivery SystemNitric Oxide delivered via LungFit system. Patients will receive inhalations of 150 ppm for 40 minutes 4 time per day plus standard supportive care. | Combination product | Phase 2- Group 1- Nitric oxide treatment- 150ppm |
| 80 ppm Nitric Oxide delivered through LungFit Delivery SystemNitric Oxide delivered via LungFit system. Patients will receive inhalations of 80 ppm for 40 minutes 4 time per day plus standard supportive care. | Combination product | Phase 1- Nitric oxide treatment- 80ppm |
Primary outcome
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
1 secondary outcome
Time to stable oxygen saturation
Time frame: up to 14 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Asher Tal, MD study director
Beyond Air
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 150 ppm Nitric Oxide delivered through LungFit Delivery System and 80 ppm Nitric Oxide delivered through LungFit Delivery System in people with COVID-19 and SARS-CoV 2, run by Beyond Air Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to deterioration (time frame: up to 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2021.