Expanded Access: Pulsed, Inhaled Nitric Oxide (iNO) for the Treatment of Patients With Mild or Moderate Coronavirus Disease (COVID-19)
Latest Information Update: 23 Feb 2023
At a glance
- Drugs Nitric oxide (Primary)
- Indications COVID 2019 infections; Pneumonia; Severe acute respiratory syndrome
- Focus Expanded access; Therapeutic Use
- Sponsors Bellerophon Therapeutics
- 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
Most Recent Events
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 |
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COVID 2019 infections | treatment | - |
Pneumonia | treatment | mild, moderate |
Severe acute respiratory syndrome | treatment | - |
Biomarker
NCT Number | Biomarker Name | Biomarker Function |
---|---|---|
NCT04358588 | Nitric Oxide (NO) | Brief Title, Official Title |
Subjects
- Subject Type patients
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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 |
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|
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
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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
Trial Centres
Investigators
Investigator | Centre Name | Trial Centre Country |
---|---|---|
Hunter Gilles, MD | Acting Chief Medical Officer |
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|
Michelle Alamo
908.574.4768
show details
eap@bellerophon.com |
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|
|
Valerie Parker
908.574.4713
show details
eap@bellerophon.com |
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|
Centres
Centre Name | Location | Trial Centre Country |
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- |
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|
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Acting Chief Medical Officer |
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|
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Bellerophon Therapeutics |
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|
-
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Trial History
Event Date | Event Type | Comment |
---|---|---|
23 Feb 2023 | Other trial event | Last checked against US National Institutes of Health Updated 23 Feb 2023 |
13 Jul 2020 | Results | Results presented in a Bellerophon Therapeutics media release. Updated 16 Jul 2020 |
12 Jun 2020 | Biomarker Update | Biomarkers information updated Updated 04 Nov 2021 |
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 |
Table of Contents
References
-
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 -
ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2023;.
Available from: URL: http://clinicaltrials.gov -
Bellerophon Therapeutics. FDA Grants Bellerophon Emergency Expanded Access for INOpulse(R) for the Treatment of COVID-19 Virus. Media-Rel 2020;.
Media Release -
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
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