Back to resultsInhaled NO for the Treatment of Viral Pneumonia in Adults
Primary Purpose
Viral Pneumonia, Nitric Oxide, Respiratory Disease
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
LungFit™
Sponsored by
About this trial
This is an interventional treatment trial for Viral Pneumonia focused on measuring Inhaled Nitric Oxide, iNO, Virus, Respiratory Disease, Viral Pneumonia, COVID-19, SARS-CoV-2
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
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.
- 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.
Sites / Locations
- Shaare Zedek Medical Center
- Hasharon Medical Center
- Rabin Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Treatment
Standard of care
Arm Description
Inhaled NO delivered using LungFit™ in addition to standard of care
Standard of care
Outcomes
Primary Outcome Measures
incidence of Serious Adverse Events
Clinical safety will be assessed by incidence of Serious Adverse Events (SAEs)
Secondary Outcome Measures
fever resolution
Time to fever resolution
ICU admission
Number of patients requiring admission to ICU
Oxygen support
Time until patient no longer requires supportive oxygen
Stable room air saturation
b.d. Stable room air saturation of 93% and above or returning to baseline saturation, whichever is lower
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04606407
Brief Title
Inhaled NO for the Treatment of Viral Pneumonia in Adults
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
November 25, 2020 (Actual)
Primary Completion Date
August 7, 2022 (Actual)
Study Completion Date
August 7, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beyond Air Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Viral Pneumonia, Nitric Oxide, Respiratory Disease, Pneumonia, Viral, Inhaled Nitric Oxide, Covid19, SARS-CoV Infection
Keywords
Inhaled Nitric Oxide, iNO, Virus, Respiratory Disease, Viral Pneumonia, COVID-19, SARS-CoV-2
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Inhaled NO delivered using LungFit™ in addition to standard of care
Arm Title
Standard of care
Arm Type
No Intervention
Arm Description
Standard of care
Intervention Type
Device
Intervention Name(s)
LungFit™
Intervention Description
Patients will receive inhalations of 150 ppm for 40 min 4 times a day, up to 7 days (maximum 28 treatments)
Primary Outcome Measure Information:
Title
incidence of Serious Adverse Events
Description
Clinical safety will be assessed by incidence of Serious Adverse Events (SAEs)
Time Frame
30 days
Secondary Outcome Measure Information:
Title
fever resolution
Description
Time to fever resolution
Time Frame
Baseline to 30 days
Title
ICU admission
Description
Number of patients requiring admission to ICU
Time Frame
Baseline to 30 days
Title
Oxygen support
Description
Time until patient no longer requires supportive oxygen
Time Frame
Baseline to 30 days
Title
Stable room air saturation
Description
b.d. Stable room air saturation of 93% and above or returning to baseline saturation, whichever is lower
Time Frame
Baseline to 30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Asher Tal
Organizational Affiliation
Beyond Air
Official's Role
Study Director
Facility Information:
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
Country
Israel
Facility Name
Hasharon Medical Center
City
Petah Tikva
Country
Israel
Facility Name
Rabin Medical Center
City
Petah Tikva
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Inhaled NO for the Treatment of Viral Pneumonia in Adults
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