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

NCT04358588 | Unknown

• 1 other identifier: PULSE-EAP-001
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Coronavirus Infection; COVID-19; Pneumonia, Viral

Keywords

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

Interventions

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

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).

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Bellerophon: lead

Related Publications (3)

• 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.

  PMID: 15234326 BACKGROUND

• 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.

  PMID: 15650225 BACKGROUND

• 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.

  PMID: 15546092 BACKGROUND

MeSH Terms

Conditions

Coronavirus Infections; COVID-19; Pneumonia, Viral; Severe Acute Respiratory Syndrome; Pneumonia; Virus Diseases

Interventions

Inosine

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Ashika Ahmed, MD

  Bellerophon Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2020
• First Posted: April 24, 2020
• Last Updated: February 21, 2023

Record last verified: 2020-06