Inhaled NO for the Treatment of Viral Pneumonia in Adults

NCT04606407 | Completed DMC FDA Device

• 1 other identifier: BA_VPLF_01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• incidence of Serious Adverse Events

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

  30 days

Secondary Outcomes (4)

• fever resolution

  Baseline to 30 days

• ICU admission

  Baseline to 30 days

• Oxygen support

  Baseline to 30 days

• Stable room air saturation

  Baseline to 30 days

Study Arms (2)

Treatment

EXPERIMENTAL

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

Device: LungFit™

Standard of care

NO INTERVENTION

Standard of care

Interventions

LungFit™ DEVICE

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

Treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beyond Air Inc.: lead

Study Sites (3)

Shaare Zedek Medical Center

Jerusalem, Israel

Location

Hasharon Medical Center

Petah Tikva, Israel

Location

Rabin Medical Center

Petah Tikva, Israel

Location

MeSH Terms

Conditions

Pneumonia, Viral; Respiration Disorders; COVID-19; Severe Acute Respiratory Syndrome; Virus Diseases

Condition Hierarchy (Ancestors)

Pneumonia; Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections

Study Officials

• Asher Tal

  Beyond Air

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2020
• First Posted: October 28, 2020
• Study Start: November 25, 2020
• Primary Completion: August 7, 2022
• Study Completion: August 7, 2022
• Last Updated: December 16, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

IL (3)