Inhaled NO for the Treatment of Viral Pneumonia in Adults

Sponsor

Beyond Air Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04606407

Collaborator

(none)

Enrollment

Locations

Arms

21.4

Anticipated Duration (Months)

Patients Per Site

1.4

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Viral Pneumonia Nitric Oxide Respiratory Disease Pneumonia, Viral Inhaled Nitric Oxide Covid19 SARS-CoV Infection	Device: LungFit™	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Nov 25, 2020

Anticipated Primary Completion Date :

Sep 7, 2022

Anticipated Study Completion Date :

Sep 7, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment Inhaled NO delivered using LungFit™ in addition to standard of care	Device: LungFit™ Patients will receive inhalations of 150 ppm for 40 min 4 times a day, up to 7 days (maximum 28 treatments)
No Intervention: Standard of care Standard of care

Arm

Intervention/Treatment

Experimental: Treatment

Inhaled NO delivered using LungFit™ in addition to standard of care

Device: LungFit™

Patients will receive inhalations of 150 ppm for 40 min 4 times a day, up to 7 days (maximum 28 treatments)

No Intervention: Standard of care

Standard of care

Outcome Measures

Primary Outcome Measures

incidence of Serious Adverse Events [30 days]
Clinical safety will be assessed by incidence of Serious Adverse Events (SAEs)

Secondary Outcome Measures

fever resolution [Baseline to 30 days]
Time to fever resolution
ICU admission [Baseline to 30 days]
Number of patients requiring admission to ICU
Oxygen support [Baseline to 30 days]
Time until patient no longer requires supportive oxygen
Stable room air saturation [Baseline to 30 days]
b.d. Stable room air saturation of 93% and above or returning to baseline saturation, whichever is lower

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.