Inhaled NO for the Treatment of Viral Pneumonia in Adults

Beyond Air

Status

Completed

Conditions

Respiratory Disease

Viral Pneumonia

SARS-CoV Infection

Covid19

Nitric Oxide

Pneumonia, Viral

Inhaled Nitric Oxide

Treatments

Device: LungFit™

Study type

Interventional

Funder types

Industry

Identifiers

NCT04606407

BA_VPLF_01

Details and patient eligibility

About

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

Enrollment

40 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.