Pulsed Inhaled Nitric Oxide for the Treatment of Patients With Mild or Moderate COVID-19

February 17, 2023 updated by: Bellerophon

Expanded Access: Pulsed, Inhaled Nitric Oxide (iNO) for the Treatment of Patients With Mild or Moderate Coronavirus Disease (COVID-19)

The search for novel therapies to address the ongoing coronavirus (COVID-19) pandemic is ongoing. No proven therapies have been identified to prevent progression of the virus. Preliminary data suggest that inhaled nitric oxide (iNO) could have benefit in preventing viral progression and reducing reliance on supplemental oxygen and ventilator support.

Expanded access allows for iNO to be delivered via the portable INOpulse delivery system for the treatment of COVID-19.

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

Detailed Description

NO is a naturally produced molecule that is critical to the immune response to defend against pathogens and infections. In vitro studies have shown that NO inhibits the replication of severe acute respiratory syndrome-related coronavirus (SARS-CoV) and improves survival for cells infected with SARS-CoV. Additionally, in a clinical study of patients infected with SARS-CoV, iNO demonstrated improvements in arterial oxygenation, a reduction in ventilation support and an improvement in lung infiltrates observed on chest radiography. Based on the genetic similarities between the two coronaviruses, the data in SARS-CoV support the potential for iNO to provide meaningful benefit for patients infected with COVID-19.

The clinical spectrum of the COVID-19 infection ranges from mild signs of upper respiratory tract infection to severe pneumonia and death. Preventing disease progression in patients with mild or moderate disease would improve morbidity/mortality and significantly reduce the impact on limited healthcare resources.

Expanded access allows for iNO to be delivered via the INOpulse delivery system for the treatment of COVID-19. INOpulse technology provides targeted pulsatile delivery of iNO via portable INOpulse delivery system.

Study Type

Expanded Access

Expanded Access Type

  • Intermediate-size Population

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Signed Informed Consent Form (and assent as appropriate) prior to the initiation of any study mandated procedures or assessments.
  2. At least 18 years old
  3. Patients with proven or high suspicion of SARS-CoV-2 infection and on supplemental oxygen ≤ 10 L/minute
  4. Suspected or proven pneumonia on chest imaging
  5. Female patients of childbearing potential must have a negative pre-treatment pregnancy test (serum or urine). All female patients should take adequate precaution to avoid pregnancy.
  6. Willing and able to comply with treatment schedule and study procedures.

Exclusion Criteria:

  1. Participating in any other clinical trial of an experimental treatment for COVID-19
  2. Gas exchange and ventilation requiring the use of any continuous positive airway pressure (CPAP), or any system of Non Invasive Ventilation (NIV), with Positive End-Expiratory Pressure (PEEP) ≤ 10 cmH2O prior to initiation of iNO
  3. Pregnancy, or positive pregnancy test in a pre-dose examination
  4. Open tracheostomy
  5. Clinical contra-indication, as deemed by the attending physician
  6. Use of a nitric oxide donor agent such as nitroglycerin or drugs known to increase methemoglobin such as lidocaine, prilocaine, benzocaine or dapsone at screening
  7. Known history or clinical evidence of heart failure, left ventricular dysfunction (LVEF < 40 %)
  8. Patients reporting hemoptysis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bellerophon

Investigators

  • Study Director: Ashika Ahmed, MD, Bellerophon Therapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

April 21, 2020

First Submitted That Met QC Criteria

April 22, 2020

First Posted (Actual)

April 24, 2020

Study Record Updates

Last Update Posted (Estimate)

February 20, 2023

Last Update Submitted That Met QC Criteria

February 17, 2023

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PULSE-EAP-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on COVID-19

Clinical Trials on iNO (inhaled nitric oxide) delivered via the INOpulse Delivery System

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malawi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe