Viral PneumoniaNCT04606407
Inhaled NO for the Treatment of Viral Pneumonia in Adults
A study testing LungFit™ in people with Viral Pneumonia and Nitric Oxide, run by Beyond Air Inc. at 3 sites in Israel.
Trial summary
The purpose of this multi center, open label, randomized, study is to obtain information on the safety and efficacy of 150 ppm Nitric Oxide given in addition to the standard of care of patients with viral pneumonia Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Viral Pneumonia, Nitric Oxide, Respiratory Disease
- What is being tested?
- LungFit™
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesIsrael
- Study dates
- 25 Nov 2020to 7 Aug 2022
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients (male and female) admitted to the hospital for clinical diagnosis of viral pneumonia including COVID-19 patients that have a positive nasal swab.
- Age 18 to 80 years
- Female subjects must be willing to use medically acceptable contraception from screening to Day 30 (acceptable forms of contraception: abstinence, hormonal birth control, intrauterine device, or barrier method plus a spermicidal agent).
- Ability to understand and comply with study requirements.
- Signed informed consent by subject
Who cannot join
- Patients with pneumonia with two or more of the following:
- WBC of more than 15,000
- Lobar pneumonia
- Pleural effusion
- Patients who are treated with or require high flow nasal cannula, CPAP, intubation, mechanical ventilation, or tracheostomy
- Breastfeeding or pregnancy as evidenced by a positive pregnancy test.
Show all 16Show fewer
- 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
- Use of an investigational drug during the last 30 days prior enrollment
- Methemoglobin level >3% at screening
- Patients on chronic (over two weeks of treatment) systemic steroids (any formulation, excluding Dexamethasone or Prednisone) within 30 days prior to enrollment.
- History of daily, continuous oxygen supplementation
- Patients with BMI greater than or equal to 40
- Patients with clinically significant anemia, e.g., Hb <10.0 and/or thrombocytopenia, e.g., Platelets <75.
- Smokers who are unwilling to refrain from smoking during hospitalization
- 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.
Trial locations and contacts
3 sites in 1 country.
Israel3 sites
Shaare Zedek Medical Center
Jerusalem
Hasharon Medical Center
Petah Tikva
Rabin Medical Center
Petah Tikva
About this study
Official title: Prospective, Open-label, Randomized, Multi-Center Study for Safety and Efficacy Evaluation of Inhaled Nitric Oxide (NO) Given Intermittently to Adults With Viral Pneumonia
The purpose of this multi center, open label, randomized, study is to obtain information on the safety and efficacy of 150 ppm Nitric Oxide given in addition to the standard of care of patients with viral pneumonia
- Conditions
- Viral Pneumonia, Nitric Oxide, Respiratory Disease, Pneumonia, Viral, Inhaled Nitric Oxide, Covid19
- Being tested
- LungFit™
- Keywords
- Inhaled Nitric Oxide, iNO, Virus, Respiratory Disease, Viral Pneumonia, COVID-19, SARS-CoV-2
- Medical subject headings
- Pneumonia, Viral, Respiration Disorders, COVID-19, 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.
LungFit™Device
Patients will receive inhalations of 150 ppm for 40 min 4 times a day, up to 7 days (maximum 28 treatments)
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Inhaled NO delivered using LungFit™ in addition to standard of care Receives: Device: LungFit™ |
| Standard of care | No intervention | Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of Serious Adverse Events
Clinical safety will be assessed by incidence of Serious Adverse Events (SAEs)
Measured: 30 days
Secondary outcomes (4)
fever resolution
Time to fever resolution
Measured: Baseline to 30 days
ICU admission
Number of patients requiring admission to ICU
Measured: Baseline to 30 days
Oxygen support
Time until patient no longer requires supportive oxygen
Measured: Baseline to 30 days
Stable room air saturation
b.d. Stable room air saturation of 93% and above or returning to baseline saturation, whichever is lower
Measured: Baseline to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2020
- Study start25 Nov 2020
- Primary completion7 Aug 2022
- Study completion7 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Viral PneumoniaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beyond Air Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Asher Tal, Study director, Beyond Air
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04606407
- Sponsor's protocol ID
- BA_VPLF_01
- Status last verified
- Dec 2022
- First submitted
- 22 Oct 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
- Prospective, Open-label, Randomized, Multi-Center Study for Safety and Efficacy Evaluation of Inhaled Nitric Oxide (NO) Given Intermittently to Adults With Viral Pneumonia
- ClinicalTrials.gov ID
- NCT04606407
- Acronym / sponsor ID
- BA_VPLF_01
- Conditions
- Viral Pneumonia, Nitric Oxide, Respiratory Disease, Pneumonia, Viral, Inhaled Nitric Oxide, Covid19
- Keywords
- Inhaled Nitric Oxide, iNO, Virus, Respiratory Disease, Viral Pneumonia, COVID-19, SARS-CoV-2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Beyond Air Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Nov 2020 (actual)
- Primary completion
- 7 Aug 2022 (actual)
- Study completion
- 7 Aug 2022 (actual)
- First posted
- 28 Oct 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 multi center, open label, randomized, study is to obtain information on the safety and efficacy of 150 ppm Nitric Oxide given in addition to the standard of care of patients with viral pneumonia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: LungFit™Inhaled NO delivered using LungFit™ in addition to standard of care |
| Standard of care | No intervention | –Standard of care |
Who may qualify
- Ages
- 18 to 80 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 clinical diagnosis of viral pneumonia including COVID-19 patients that have a positive nasal swab.
- Age 18 to 80 years
- Female subjects must be willing to use medically acceptable contraception from screening to Day 30 (acceptable forms of contraception: abstinence, hormonal birth control, intrauterine device, or barrier method plus a spermicidal agent).
- Ability to understand and comply with study requirements.
- Signed informed consent by subject
Key exclusion criteria (16 listed)
- Patients with pneumonia with two or more of the following:
- Patients who are treated with or require high flow nasal cannula, CPAP, intubation, mechanical ventilation, or tracheostomy
- 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
- Use of an investigational drug during the last 30 days prior enrollment
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 |
|---|---|---|
| LungFit™Patients will receive inhalations of 150 ppm for 40 min 4 times a day, up to 7 days (maximum 28 treatments) | Device | Treatment |
Primary outcome
incidence of Serious Adverse Events
Time frame: 30 days
Clinical safety will be assessed by incidence of Serious Adverse Events (SAEs)
4 secondary outcomes
fever resolution
Time frame: Baseline to 30 days
ICU admission
Time frame: Baseline to 30 days
Oxygen support
Time frame: Baseline to 30 days
Stable room air saturation
Time frame: Baseline to 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2022.
- Individual participant dataSharing planned: No
Related trials for Viral Pneumonia
RecruitingPhase 3
A Study to Learn About a Study Medicine Called Ibuzatrelvir in Adult and Adolescent Patients With COVID-19 Who Are Not Hospitalized But Are at Risk For Severe Disease
COVID-19 SARS-CoV-2 Infection
RecruitingPhase 3
A Study to Learn About the Study Medicine Ibuzatrelvir in Adults With COVID-19 Who Are Severely Immunocompromised
COVID-19 Infection
Active, not recruitingPhase 2
Phase 2a Multiple Ascending Dose Study in Hospitalized Patients With Pneumonia.
Acute Respiratory Distress Syndrome, Viral or Bacterial Infections
RecruitingPhase 3
A Study of COVID-19 Vaccine(s) in Children and Adults
COVID-19 Vaccines
Active, not recruitingObservational study
RSV, Influenza, and SARS-CoV-2 Outcomes in Severely Immunosuppressed Adults
Respiratory Syncytial Virus Infections, Immunocompromised Host
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 study director
Beyond Air
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LungFit™ in people with Viral Pneumonia and Nitric Oxide, run by Beyond Air Inc. at 3 sites in Israel.
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 16 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: finished, 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 3 sites in Israel. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
incidence of Serious Adverse Events (time frame: 30 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; AzTrials last refreshed its copy on 8 Nov 2026.