Inhaled NO for the Treatment of Viral Pneumonia in Adults

NCT ID: NCT04606407

Last Updated: 2022-12-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-25
• Study Completion Date: 2022-08-07

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

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

Group Type: EXPERIMENTAL

LungFit™

Intervention Type: DEVICE

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

Standard of care

Standard of care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

LungFit™

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beyond Air Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Asher Tal

Role: STUDY_DIRECTOR

Beyond Air

Locations

Shaare Zedek Medical Center

Jerusalem, , Israel

Hasharon Medical Center

Petah Tikva, , Israel

Rabin Medical Center

Petah Tikva, , Israel

Countries

Israel

Other Identifiers

BA_VPLF_01

Identifier Type: -

Identifier Source: org_study_id