Trial Profile
Inhaled Gaseous Nitric Oxide (gNO) Antimicrobial Treatment of Difficult Bacterial and Viral Lung (COVID-19) Infections
Status:
Planning
Phase of Trial:
Phase I
Latest Information Update: 06 Apr 2020
At a glance
- Drugs Nitric oxide (Primary)
- Indications COVID 2019 infections; Lung disorders
- Focus Therapeutic Use
- 06 Apr 2020 New trial record
- 01 Apr 2020 According to an Mallinckrodt plc media release, Dr. Chris Miller is the team lead for the study at Vancouver Coastal Health Research Institute.
- 01 Apr 2020 According to an Mallinckrodt plc media release, the companies expect to begin recruiting patients in the coming days.
Most Recent Events
Trial Overview
Purpose
This pilot study will investigate the Inhaled Gaseous Nitric Oxide (gNO)'s safety and effectiveness in treating COVID-19 and its associated lung complications. The investigative therapy employs Novoteris' Inhaled Nitric Oxide Delivery Device (INODD) and Mallinckrodt's high-concentration, 5000 PPM nitric oxide gas for inhalation canisters.
Diseases Treated
| Indication | Qualifiers | Patient Segments |
|---|---|---|
| COVID 2019 infections | treatment | - |
| Lung disorders | treatment | - |
Subjects
- Subject Type patients
- Sex male & female
Trial Details
Organisations
- Affiliations Mallinckrodt plc; Novoteris
Trial Dates
Other Details
- Design prospective
- Phase of Trial Phase I
- Location Canada
- Focus Therapeutic Use
Interventions
| Drugs | Route | Formulation |
|---|---|---|
| Nitric oxidePrimary Drug | Inhalation |
-
|
Inhaled Gaseous Nitric Oxide (gNO)
Trial History
| Event Date | Event Type | Comment |
|---|---|---|
| 06 Apr 2020 | New trial record | New trial record Updated 06 Apr 2020 |
| 01 Apr 2020 | Other trial event | According to an Mallinckrodt plc media release, Dr. Chris Miller is the team lead for the study at Vancouver Coastal Health Research Institute. Updated 06 Apr 2020 |
| 01 Apr 2020 | Other trial event | According to an Mallinckrodt plc media release, the companies expect to begin recruiting patients in the coming days. Updated 06 Apr 2020 |
| 01 Apr 2020 | Other trial event | According to an Mallinckrodt plc media release, the company and Novoteris, announced that the Therapeutic Products Directorate of Health Canada has cleared the companies joint pilot trial, entitled "Inhaled Gaseous Nitric Oxide (gNO) Antimicrobial Treatment of Difficult Bacterial and Viral Lung (COVID-19) Infections" application to investigate the use of Thiolanox, for the treatment of patients infected with novel coronavirus (SARS-CoV-2) at Vancouver Coastal Health Authority facilities. Updated 06 Apr 2020 |
References
-
Mallinckrodt plc. Mallinckrodt and Novoteris Receive Clearance from Health Canada to Start Pilot Trial of High-Dose Inhaled Nitric Oxide Therapy for COVID-19 Infection and Associated Lung Complications. Media-Rel 2020;.
Media Release
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