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OpenTrials
Completed

NCT Number: NCT04606407

Inhaled NO for the Treatment of Viral Pneumonia in Adults

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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shaare Zedek Medical Center, Jerusalem, Israel

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LungFit™

Device

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

Primary outcomes

  1. incidence of Serious Adverse Events

    Time frame: 30 days

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

Secondary outcomes

  1. fever resolution

    Time frame: Baseline to 30 days

    Time to fever resolution

  2. ICU admission

    Time frame: Baseline to 30 days

    Number of patients requiring admission to ICU

  3. Oxygen support

    Time frame: Baseline to 30 days

    Time until patient no longer requires supportive oxygen

  4. Stable room air saturation

    Time frame: Baseline to 30 days

    b.d. Stable room air saturation of 93% and above or returning to baseline saturation, whichever is lower

Sponsors and collaborators

Lead sponsor

Beyond Air Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 28, 2020
Registry last updated
Dec 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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