Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

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

Trial Profile

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

Status: Completed
Phase of Trial: Clinical Phase Unknown

Latest Information Update: 13 Jul 2020

At a glance

  • Drugs Nitric oxide (Primary)
  • Indications COVID 2019 infections; Pneumonia; Severe acute respiratory syndrome
  • Focus Expanded access; Therapeutic Use
  • Sponsors Bellerophon Therapeutics
  • Most Recent Events

    • 13 Jul 2020 Results presented in a Bellerophon Therapeutics media release.
    • 10 Jun 2020 Status changed from recruiting to completed.
    • 03 Apr 2020 New trial record

Trial Overview

Purpose

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.

Diseases Treated

Indication Qualifiers Patient Segments
COVID 2019 infections treatment -
Pneumonia treatment mild, moderate
Severe acute respiratory syndrome treatment -

Subjects

  • Subject Type patients
  • Number

    Actual: 180

  • Sex male & female
  • Age Group 18-95 years; adult; elderly

Patient 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.

Patient 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

Trial Details

Identifiers

Identifier Owner
NCT04358588 ClinicalTrials.gov: US National Institutes of Health
PULSE-EAP001 -

Organisations

  • Sponsors Bellerophon Therapeutics
  • Affiliations Bellerophon Therapeutics

Trial Dates

Other Details

  • Design prospective
  • Phase of Trial Clinical Phase Unknown
  • Location USA
  • Focus Expanded access; Therapeutic Use

Interventions

Drugs Route Formulation
Nitric oxidePrimary Drug Inhalation
-

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

Results

Therapeutic efficacy

COVID-2019 infections: In an expanded assess programme, inhaled nitric oxide therapy demonstrated improved oxygenation in patients (n=180) with COVID-2019 infections. In the study recovery rate at day 14 was 73% and mortality rate was 7.3% among the patients [1] .

Adverse events

In an expanded assess programme, inhaled nitric oxide therapy was safe and well tolerated in patients with COVID-2019 infections. The data were reported from 180 patients [1] .

Publications

  1. Bellerophon Therapeutics. Bellerophon Therapeutics Announces First Patient Treated in Phase 3 Clinical Study of INOpulse(Rm) Inhaled Nitric Oxide Therapy for COVID-19. Media-Rel 2020;.

    Media Release

Authors

Author Total Publications First Author Last Author
Bellerophon Therapeutics 1 1 1

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
Hunter Gilles, MD Acting Chief Medical Officer
-
Michelle Alamo
908.574.4768
eap@bellerophon.com
show details
-
Valerie Parker
908.574.4713
eap@bellerophon.com
show details
-

Centres

Centre Name Location Trial Centre Country
-
-
-
Acting Chief Medical Officer
-
-
Bellerophon Therapeutics
-
-

Trial History

Event Date Event Type Comment
13 Jul 2020 Results Results presented in a Bellerophon Therapeutics media release. Updated 16 Jul 2020
15 Jun 2020 Other trial event Last checked against US National Institutes of Health Updated 15 Jun 2020
10 Jun 2020 Status change - completed Status changed from recruiting to completed. Updated 15 Jun 2020
27 Apr 2020 Other trial event New source identified and integrated ClinicalTrials.gov: (US National Institutes of Health: NCT04358588). Updated 27 Apr 2020
03 Apr 2020 New trial record New trial record Updated 03 Apr 2020
31 Mar 2020 Status change - recruiting Status changed from planning to recruiting, according to a Bellerophon Therapeutics media release. Updated 03 Apr 2020
31 Mar 2020 Other trial event According to a Bellerophon Therapeutics media release, the company will host an investor conference call and webcast on the INOpulse inhaled nitric oxide system (iNO) for the treatment of COVID-19 on 31st Mar 2020 at 1:00 PM EDT.The event will feature a presentation which will discuss the Companys emergency expanded access program for INOpulse for COVID-19, through which the first patient initiated treatment. Updated 03 Apr 2020
20 Mar 2020 Other trial event According to a Bellerophon Therapeutics media release, the U.S. Food and Drug Administration (FDA) has granted emergency expanded access allowing its proprietary inhaled nitric oxide (iNO) delivery system, INOpulse, to immediately be used for the treatment of COVID-19. Updated 03 Apr 2020

References

  1. Bellerophon Therapeutics. Bellerophon Therapeutics Announces First Patient Treated in Phase 3 Clinical Study of INOpulse(Rm) Inhaled Nitric Oxide Therapy for COVID-19. Media-Rel 2020;.

    Media Release
  2. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2016;.

    Available from: URL: http://clinicaltrials.gov
  3. Bellerophon Therapeutics. FDA Grants Bellerophon Emergency Expanded Access for INOpulse(R) for the Treatment of COVID-19 Virus. Media-Rel 2020;.

    Media Release
  4. Bellerophon Therapeutics. Bellerophon Therapeutics to Host Investor Call and Webcast Today on INOpulse(Rm) for the Treatment of COVID-19. Media-Rel 2020;.

    Media Release
Back to top