Inhaled NO for the Treatment of Viral Pneumonia in Adults

Covid19 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04606407
• Other study ID #: BA_VPLF_01
• Status: Completed
• Phase: N/A
• Start date: November 25, 2020
• Est. completion date: August 7, 2022

Study information

• Verified date: December 2022
• Source: Beyond Air Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 7, 2022
• Est. primary completion date: August 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Inhaled Nitric Oxide
• Nitric Oxide
• Pneumonia
• Pneumonia, Viral
• Respiration Disorders
• Respiratory Aspiration
• Respiratory Disease
• Respiratory Tract Diseases
• SARS-CoV Infection
• Severe Acute Respiratory Syndrome
• Viral Pneumonia

Intervention

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

Locations

Country	Name	City	State
Israel	Shaare Zedek Medical Center	Jerusalem
Israel	Hasharon Medical Center	Petah Tikva
Israel	Rabin Medical Center	Petah Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Beyond Air Inc.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of Serious Adverse Events	Clinical safety will be assessed by incidence of Serious Adverse Events (SAEs)	30 days
Secondary	fever resolution	Time to fever resolution	Baseline to 30 days
Secondary	ICU admission	Number of patients requiring admission to ICU	Baseline to 30 days
Secondary	Oxygen support	Time until patient no longer requires supportive oxygen	Baseline to 30 days
Secondary	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