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

Phase 3TerminatedNCT04421508

Bellerophon Pulse Technologies191 enrolled

Overview

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.

This is a randomized, double-blind, placebo-controlled study to assess the efficacy and safety of pulsed iNO compared to placebo in subjects with COVID-19 who are hospitalized and require supplemental oxygen without assisted ventilation. Subjects will be randomized to receive placebo or iNO125 mcg/kg ideal body weight (IBW)/hour 24 hours daily up to 14 days or until resolution or discharge.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

191

Conditions

COVID-19 Coronavirus Coronavirus Infection

Interventions

INOpulseCOMBINATION_PRODUCT

Subjects will be treated by means of an INOpulse device using an INOpulse nasal cannula.

PlaceboCOMBINATION_PRODUCT

Subjects will be treated by means of an INOpulse device using an INOpulse nasal cannula.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Locations (17)

Banner University Medical Center

Phoenix, Arizona, United States

Kaiser Permanente - Zion Medical Center

San Diego, California, United States

Outcomes

Primary Outcomes

The Number of Subjects Who Died or Had Respiratory Failure

The number of subjects who died or had respiratory failure through Day 28

Time frame: Through Day 28

Secondary Outcomes

Number of Subjects to Recover

Number of subjects to recover, where recover is defined as attaining a NIAID Ordinal score of 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen or 8) Not hospitalized, no limitations on activities sustained through Day 28, or discharge from hospital without re admission for COVID.

Time frame: Through Day 28

Clinical Status Using National Institute of Allergy and Infectious Diseases (NIAID) 8-point Ordinal Scale

The assessment of clinical status at the first assessment of a study day. The scale is: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.

Time frame: Day 7

Clinical Status Using National Institute of Allergy and Infectious Diseases (NIAID) 8-point Ordinal Scale

Data from ClinicalTrials.gov

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