Inhaled NO for the Treatment of Viral Pneumonia in Adults

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

Study Overview

• Status: Completed
• Conditions: Pneumonia, Viral; Covid19; SARS-CoV Infection; Nitric Oxide; Respiratory Disease; Viral Pneumonia; Inhaled Nitric Oxide
• Intervention / Treatment: Device: LungFit™

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Jerusalem, Israel
    • Shaare Zedek Medical Center
  • Petah Tikva, Israel
    • Rabin Medical Center
  • Petah Tikva, Israel
    • Hasharon Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of care
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of Serious Adverse Events	Clinical safety will be assessed by incidence of Serious Adverse Events (SAEs)	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
fever resolution	Time to fever resolution	Baseline to 30 days
ICU admission	Number of patients requiring admission to ICU	Baseline to 30 days
Oxygen support	Time until patient no longer requires supportive oxygen	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	Baseline to 30 days

Collaborators and Investigators

• Sponsor: Beyond Air Inc.
• Investigators: Study Director: Asher Tal, Beyond Air

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2020
• Primary Completion (Actual): August 7, 2022
• Study Completion (Actual): August 7, 2022

Study Registration Dates

• First Submitted: October 22, 2020
• First Submitted That Met QC Criteria: October 27, 2020
• First Posted (Actual): October 28, 2020

Study Record Updates

• Last Update Posted (Actual): December 16, 2022
• Last Update Submitted That Met QC Criteria: December 14, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: SARS-CoV-2; COVID-19; Virus; Inhaled Nitric Oxide; Viral Pneumonia; iNO; Respiratory Disease
• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Lung Diseases; Severe Acute Respiratory Syndrome; COVID-19; Respiratory Aspiration; Pneumonia; Pneumonia, Viral; Respiration Disorders; Respiratory Tract Diseases
• Other Study ID Numbers: BA_VPLF_01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes