Inhaled NO for the Treatment of Viral Pneumonia in Adults

Beyond Air Inc. (Industry)
Overall Status
Recruiting ID

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
  • Device: LungFit™

Study Design

Study Type:
Anticipated Enrollment :
90 participants
Intervention Model:
Parallel Assignment
None (Open Label)
Primary Purpose:
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

Outcome Measures

Primary Outcome Measures

  1. incidence of Serious Adverse Events [30 days]

    Clinical safety will be assessed by incidence of Serious Adverse Events (SAEs)

Secondary Outcome Measures

  1. fever resolution [Baseline to 30 days]

    Time to fever resolution

  2. ICU admission [Baseline to 30 days]

    Number of patients requiring admission to ICU

  3. Oxygen support [Baseline to 30 days]

    Time until patient no longer requires supportive oxygen

  4. 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


Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
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:
  1. WBC of more than 15,000

  2. Lobar pneumonia

  3. 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.

Contacts and Locations


Site City State Country Postal Code
1 Shaare Zedek Medical Center Jerusalem Israel
2 Hasharon Medical Center Petah Tikva Israel
3 Rabin Medical Center Petah Tikva Israel

Sponsors and Collaborators

  • Beyond Air Inc.


  • Study Director: Asher Tal, Beyond Air

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
Beyond Air Inc. Identifier:
Other Study ID Numbers:
  • BA_VPLF_01
First Posted:
Oct 28, 2020
Last Update Posted:
Feb 1, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Product Manufactured in and Exported from the U.S.:
Keywords provided by Beyond Air Inc.
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 1, 2022