A Study to Assess Pulsed Inhaled Nitric Oxide vs Placebo in Subjects With Mild or Moderate COVID-19

Stopped early · Phase 3 · Has a placebo group

Conditions studied: COVID-19, Coronavirus, Coronavirus Infection

In brief

A randomized, double-blind, placebo-controlled study to assess the efficacy and safety of pulsed inhaled iNO compared to placebo in subjects with COVID-19.

Key facts

Study ID

NCT04421508

Run by

Bellerophon Pulse Technologies

People needed

191

Starts

2020-07-12

Expected to finish

2021-01-22

Last updated by the study team

2023-02-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed informed consent
• At least 18 years old
• Subjects must be hospitalized and have the following:
• proven or high suspicion of SARS-CoV-2 infection and,
• requiring oxygen supplementation defined as:
• SpO2 ≤ 92% regardless of supplemental oxygen (ie on room air or on oxygen), or
• SpO2 ≥ 92% on supplemental O2 and in the opinion of the Investigator it is not safe to decrease or remove the supplemental oxygen
• require supplemental oxygen of no more than 10 L/minute, and
• radiologic suspected or proven COVID-19 pneumonitis (chest x-ray or CT scan)
• Female subjects must have a negative pregnancy test
• Willing and able to comply with the treatment schedule and study procedures

You may not qualify if…

• Participating in another clinical trial of an investigational treatment for COVID-19
• Methemoglobin > 3%
• Evidence of severe multi organ failure
• Use of assisted ventilation prior to initiation of iNO
• Pregnancy or positive pregnancy test pre-dose
• Open tracheostomy
• Chronic use of a nitric oxide donor agent such as nitroglycerin or drugs known to increase methemoglobin such as lidocaine, prilocaine, benzocaine, nitroprusside, isosorbide, or dapsone at screening
• History or clinical evidence of systolic heart failure, left ventricular dysfunction (LVEF <40%)
• Subjects reporting massive hemoptysis associated with the current illness or with radiologically proven pulmonary embolus

Where it is running

• Banner University Medical Center — Phoenix, Arizona, United States
• Kaiser Permanente - Zion Medical Center — San Diego, California, United States
• Kaiser Permanente - San Diego Medical Center — San Diego, California, United States
• University of Miami Health System — Miami, Florida, United States
• The Lung Research Center (St. Luke's) — Chesterfield, Missouri, United States
• University of New Mexico Hospital — Albuquerque, New Mexico, United States
• The Ohio State University Wexner Medical Center — Columbus, Ohio, United States
• Mercy Health St. Vincent Medical Center — Toledo, Ohio, United States
• Temple University Hospital — Philadelphia, Pennsylvania, United States
• Houston Methodist — Houston, Texas, United States
• INOVA — Falls Church, Virginia, United States
• St. Francis Medical Center — Richmond, Virginia, United States
• Memorial Regional Medical Center — Richmond, Virginia, United States
• Chippenham Medical Center — Richmond, Virginia, United States
• Pulmonary Associates of Richmond — Richmond, Virginia, United States
• St. Mary's Hospital — Richmond, Virginia, United States
• Johnston-Willis Hospital — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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