Clinical trial NCT04606407: Inhaled NO for the Treatment of Viral Pneumonia in Adults
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Viral Pneumonia
Nitric Oxide
Respiratory Disease
Pneumonia, Viral
Inhaled Nitric Oxide
Covid19
SARS-CoV Infection
Keywords: Inhaled Nitric Oxide
iNO
Virus
Respiratory Disease
Viral Pneumonia
COVID-19
SARS-CoV-2
Lead sponsor: Beyond Air Inc.
Sponsor class: INDUSTRY
First posted: 2020-10-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: incidence of Serious Adverse Events
timeFrame: 30 days
Secondary outcomes:
measure: fever resolution
timeFrame: Baseline to 30 days
measure: ICU admission
timeFrame: Baseline to 30 days
measure: Oxygen support
timeFrame: Baseline to 30 days
measure: Stable room air saturation
timeFrame: Baseline to 30 days
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Petah Tikva
country: Israel
facility: Hasharon Medical Center
city: Petah Tikva
country: Israel
facility: Rabin Medical Center
Study officials:
affiliation: Beyond Air
name: Asher Tal
role: STUDY_DIRECTOR
References: