Corona Virus InfectionNCT04397692
Inhaled NO for the Treatment of COVID-19 Caused by SARS-CoV-2 (US Trial)
A study testing Nitric Oxide delivered via LungFit™ system in people with Corona Virus Infection and COVID-19, run by Beyond Air Inc. at 1 site in United States.
Trial summary
The purpose of this open label, randomized, study is to obtain information on the safety and efficacy of 80 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 65 years
- Conditions the study is for
- Corona Virus Infection, COVID-19, SARS-CoV 2
- What is being tested?
- Nitric Oxide delivered via LungFit™ system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jun 2020to 30 Sep 2020
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Enrollment within 24 hours of hospital admission of patients diagnosed with COVID-19
- Patients with oxygen saturation less than 93 % on room air
- Shortness of breath, with symptom onset within the previous 8 days.
- Female subjects of childbearing potential should take adequate measures to avoid pregnancy
- Signed informed consent by the 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
- Subjects diagnosed with immunodeficiency, with history of congestive or unstable heart disease, left ventricular dysfunction or myocardial damage, severe pulmonary hypertension and/or unstable hypertension
- Patients receiving drugs that have contraindications with NO.
- Breastfeeding or pregnancy as evidenced by a positive pregnancy test.
- Patients with active pulmonary malignancy or lung transplant
- Patients with a history of frequent epistaxis or significant hemoptysis
Trial locations and contacts
1 site in 1 country.
United States1 site
Baptist Health Center for Clinical Research
Little Rock, Arkansas, 72205
About this study
The purpose of this open label, randomized, study is to obtain information on the safety and efficacy of 80 ppm Nitric Oxide given in addition to the standard of care of patients with COVID-19 caused by SARS-CoV-2.
Read the detailed description
Nitric Oxide (NO) is a small endogenously produced molecule recognized to play a critical role in the function of several body systems including the vasodilatation of smooth muscle, neurotransmission, regulation of wound healing and inhibition of pathogens. In-vitro studies have shown that NO inhibits the replication cycle of the severe acute respiratory syndrome coronavirus (SARS CoV) in vitro. The suggested mechanisms of actions of NO on SARS are an effect on the fusion between the S protein and its cognate receptor, ACE2, and reduction in viral RNA production in the early steps of viral replication. The primary aim of this feasibility study is to investigate the safety of intermittent NO, delivered via inhalation, in hospitalized patients with COVID-19. The primary endpoint in the study will be time to deterioration of respiratory symptoms determined by escalation to either non-invasive ventilation (NIV), high-flow nasal cannula (HFNC), or intubation.
- Conditions
- Corona Virus Infection, COVID-19, SARS-CoV 2, Nitric Oxide, Respiratory Disease, Pneumonia, Viral
- Being tested
- Nitric Oxide delivered via LungFit™ system
- Keywords
- COVID-19, Coronavirus, Inhaled Nitric Oxide, iNO, SARS-coronavirus, Virus
- Medical subject headings
- Coronavirus Infections, COVID-19, Respiration Disorders, Pneumonia, Viral, Severe Acute Respiratory Syndrome, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitric Oxide delivered via LungFit™ systemDevice
Patients will receive inhalations of 80 ppm for 40 min 4 times a day
| Study group | Role | What they receive |
|---|---|---|
| Inhaled NO delivered using LungFit™ in addition to SST | Experimental | Patients will receive 80 ppm iNO for 40 min 4 times a day using LungFit™ device in addition to the standard of care. Receives: Device: Nitric Oxide delivered via LungFit™ system |
| Standard of care | No intervention | Control - 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 measured by need for NIV, HFNC or intubation
Measured: 14 Days
Secondary outcomes (4)
Time to NIV
Time to non-invasive ventilation
Measured: 14 Days
Time to HFNC
Time to high flow nasal cannula
Measured: 14 Days
Time to intubation
Time to intubation
Measured: 14 days
Time to patient having stable oxygen saturation (SpO2) of greater than or equal to 93%
Time to patient having stable oxygen saturation (SpO2) of greater than or equal to 93%
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study start13 Jun 2020
- Primary completion30 Sep 2020
- Study completion30 Sep 2020
Why it stopped: Slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corona Virus InfectionStudies 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 N/A
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beyond Air Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ashik Tal, MD, Study director, Beyond Air
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04397692
- Sponsor's protocol ID
- BAI_COV19_01_US
- Status last verified
- Dec 2022
- First submitted
- 19 May 2020
- Last updated
- 16 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2022. 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 (US Trial)
- ClinicalTrials.gov ID
- NCT04397692
- Acronym / sponsor ID
- BAI_COV19_01_US
- Conditions
- Corona Virus Infection, COVID-19, SARS-CoV 2, Nitric Oxide, Respiratory Disease, Pneumonia, Viral
- Keywords
- COVID-19, Coronavirus, Inhaled Nitric Oxide, iNO, SARS-coronavirus, Virus
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recruitment
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Beyond Air Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Jun 2020 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 21 May 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, randomized, study is to obtain information on the safety and efficacy of 80 ppm Nitric Oxide given in addition to the standard of care of patients with COVID-19 caused by SARS-CoV-2.
Detailed description
Nitric Oxide (NO) is a small endogenously produced molecule recognized to play a critical role in the function of several body systems including the vasodilatation of smooth muscle, neurotransmission, regulation of wound healing and inhibition of pathogens. In-vitro studies have shown that NO inhibits the replication cycle of the severe acute respiratory syndrome coronavirus (SARS CoV) in vitro. The suggested mechanisms of actions of NO on SARS are an effect on the fusion between the S protein and its cognate receptor, ACE2, and reduction in viral RNA production in the early steps of viral replication. The primary aim of this feasibility study is to investigate the safety of intermittent NO, delivered via inhalation, in hospitalized patients with COVID-19. The primary endpoint in the study will be time to deterioration of respiratory symptoms determined by escalation to either non-invasive ventilation (NIV), high-flow nasal cannula (HFNC), or intubation.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inhaled NO delivered using LungFit™ in addition to SST | Experimental | Device: Nitric Oxide delivered via LungFit™ systemPatients will receive 80 ppm iNO for 40 min 4 times a day using LungFit™ device in addition to the standard of care. |
| Standard of care | No intervention | –Control - Standard of care |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Enrollment within 24 hours of hospital admission of patients diagnosed with COVID-19
- Patients with oxygen saturation less than 93 % on room air
- Shortness of breath, with symptom onset within the previous 8 days.
- Female subjects of childbearing potential should take adequate measures to avoid pregnancy
- Signed informed consent by the subject
Key exclusion criteria (7 listed)
- Patients who are treated with or require high flow nasal cannula, CPAP, intubation, mechanical ventilation, or tracheostomy
- Diagnosis of acute respiratory distress syndrome
- Subjects diagnosed with immunodeficiency, with history of congestive or unstable heart disease, left ventricular dysfunction or myocardial damage, severe pulmonary hypertension and/or unstable hypertension
- Patients receiving drugs that have contraindications with NO.
- Breastfeeding or pregnancy as evidenced by a positive pregnancy test.
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 |
|---|---|---|
| Nitric Oxide delivered via LungFit™ systemPatients will receive inhalations of 80 ppm for 40 min 4 times a day | Device | Inhaled NO delivered using LungFit™ in addition to SST |
Primary outcome
Time to deterioration
Time frame: 14 Days
Time to deterioration measured by need for NIV, HFNC or intubation
4 secondary outcomes
Time to NIV
Time frame: 14 Days
Time to HFNC
Time frame: 14 Days
Time to intubation
Time frame: 14 days
Time to patient having stable oxygen saturation (SpO2) of greater than or equal to 93%
Time frame: 14 days
Results and safety
The study was stopped early (reason given: Slow recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2022.
- 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.
Ashik Tal, MD study director
Beyond Air
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nitric Oxide delivered via LungFit™ system in people with Corona Virus Infection and COVID-19, run by Beyond Air Inc. at 1 site in United States.
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 7 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: stopped early, as of the sponsor's last update on 16 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study was stopped early (reason given: Slow recruitment). Results are not available in the source record.
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: 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 16 Dec 2022.