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

Primary Purpose

Coronavirus Infection, COVID-19, Pneumonia, Viral

Status

No longer available

Phase

Locations

Study Type

Expanded Access

Intervention

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

About this trial

This is an expanded access trial for Coronavirus Infection focused on measuring coronavirus, corona virus, COVID-19, COVID 19, SARS, SARS-coronavirus, Pneumonia, Pneumonia, viral, Virus

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)All Sexes

Inclusion Criteria:

Signed Informed Consent Form (and assent as appropriate) prior to the initiation of any study mandated procedures or assessments.
At least 18 years old
Patients with proven or high suspicion of SARS-CoV-2 infection and on supplemental oxygen ≤ 10 L/minute
Suspected or proven pneumonia on chest imaging
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.
Willing and able to comply with treatment schedule and study procedures.

Exclusion Criteria:

Participating in any other clinical trial of an experimental treatment for COVID-19
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
Pregnancy, or positive pregnancy test in a pre-dose examination
Open tracheostomy
Clinical contra-indication, as deemed by the attending physician
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
Known history or clinical evidence of heart failure, left ventricular dysfunction (LVEF < 40 %)
Patients reporting hemoptysis

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT04358588

First Posted

April 21, 2020

Last Updated

February 17, 2023

Sponsor

Bellerophon

1. Study Identification

Unique Protocol Identification Number

NCT04358588

Brief Title

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

Official Title

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

Study Type

Expanded Access

2. Study Status

Record Verification Date

June 2020

Overall Recruitment Status

No longer available

Study Start Date

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Primary Completion Date

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Study Completion Date

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3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bellerophon

4. Oversight

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronavirus Infection, COVID-19, Pneumonia, Viral

Keywords

coronavirus, corona virus, COVID-19, COVID 19, SARS, SARS-coronavirus, Pneumonia, Pneumonia, viral, Virus

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

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

Intervention Description

Patients will be treated by means of an INOpulse device and cannula. The active study drug, nitric oxide for inhalation (iNO), will be provided in size 0.074 liter aluminum cartridge at a concentration of 6.0 mg/L (4880 ppm).

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

95 Years

Eligibility Criteria

Inclusion Criteria: Signed Informed Consent Form (and assent as appropriate) prior to the initiation of any study mandated procedures or assessments. At least 18 years old Patients with proven or high suspicion of SARS-CoV-2 infection and on supplemental oxygen ≤ 10 L/minute Suspected or proven pneumonia on chest imaging 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. Willing and able to comply with treatment schedule and study procedures. Exclusion Criteria: Participating in any other clinical trial of an experimental treatment for COVID-19 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 Pregnancy, or positive pregnancy test in a pre-dose examination Open tracheostomy Clinical contra-indication, as deemed by the attending physician 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 Known history or clinical evidence of heart failure, left ventricular dysfunction (LVEF < 40 %) Patients reporting hemoptysis

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ashika Ahmed, MD

Organizational Affiliation

Bellerophon Therapeutics

Official's Role

Study Director

12. IPD Sharing Statement

Citations:

PubMed Identifier

15234326

Citation

Keyaerts E, Vijgen L, Chen L, Maes P, Hedenstierna G, Van Ranst M. Inhibition of SARS-coronavirus infection in vitro by S-nitroso-N-acetylpenicillamine, a nitric oxide donor compound. Int J Infect Dis. 2004 Jul;8(4):223-6. doi: 10.1016/j.ijid.2004.04.012.

Results Reference

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PubMed Identifier

15650225

Citation

Akerstrom S, Mousavi-Jazi M, Klingstrom J, Leijon M, Lundkvist A, Mirazimi A. Nitric oxide inhibits the replication cycle of severe acute respiratory syndrome coronavirus. J Virol. 2005 Feb;79(3):1966-9. doi: 10.1128/JVI.79.3.1966-1969.2005.

Results Reference

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PubMed Identifier

15546092

Citation

Chen L, Liu P, Gao H, Sun B, Chao D, Wang F, Zhu Y, Hedenstierna G, Wang CG. Inhalation of nitric oxide in the treatment of severe acute respiratory syndrome: a rescue trial in Beijing. Clin Infect Dis. 2004 Nov 15;39(10):1531-5. doi: 10.1086/425357. Epub 2004 Oct 22.

Results Reference

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Learn more about this trial

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

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