Inhaled NO for the Treatment of Viral Pneumonia in Adults

Not Applicable

Completed

• Conditions: Covid19; Respiratory Disease; Pneumonia, Viral; Viral Pneumonia; Nitric Oxide; Inhaled Nitric Oxide; SARS-CoV Infection
• Interventions: Device: LungFit™

• Registration Number: NCT04606407
• Lead Sponsor: Beyond Air Inc.

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-22
• Study First Submitted QC: 2020-10-27
• Study First Posted: 2020-10-28
• Study Start: 2020-11-25
• Primary Completion: 2022-08-07
• Study Completion: 2022-08-07
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-14
• Last Update Posted: 2022-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	LungFit™	Inhaled NO delivered using LungFit™ in addition to standard of care

Primary Outcome Measures

Name	Time	Method
incidence of Serious Adverse Events	30 days	Clinical safety will be assessed by incidence of Serious Adverse Events (SAEs)

Secondary Outcome Measures

Name	Time	Method
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
fever resolution	Baseline to 30 days	Time to fever resolution
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

Trial Locations

Locations (3)

Hasharon Medical Center; 🇮🇱 Petah Tikva, Israel

Rabin Medical Center; 🇮🇱 Petah Tikva, Israel

Shaare Zedek Medical Center; 🇮🇱 Jerusalem, Israel