Inhaled NO for the Treatment of Viral Pneumonia in Adults

Study Overview
=================
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

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

Conditions
-----------------
Viral Pneumonia, Nitric Oxide, Respiratory Disease, Pneumonia, Viral, Inhaled Nitric Oxide, Covid19, SARS-CoV Infection

Intervention / Treatment
-----------------
* Device: LungFit™


Participation Criteria
=================
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: 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Inhaled NO delivered using LungFit™ in addition to standard of care | Device: LungFit™<br>* Patients will receive inhalations of 150 ppm for 40 min 4 times a day, up to 7 days (maximum 28 treatments)<br>|
| No Intervention: Standard of care<br>Standard of care | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of Serious Adverse Events | Clinical safety will be assessed by incidence of Serious Adverse Events (SAEs) | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fever resolution | Time to fever resolution | Baseline to 30 days | 
| ICU admission | Number of patients requiring admission to ICU | Baseline to 30 days | 
| Oxygen support | Time until patient no longer requires supportive oxygen | Baseline to 30 days | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Inhaled Nitric Oxide, iNO, Virus, Respiratory Disease, Viral Pneumonia, COVID-19, SARS-CoV-2