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Inhaled Gaseous Nitric Oxide (gNO) Antimicrobial Treatment of Difficult Bacterial and Viral Lung (COVID-19) Infections

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
  • Most Recent Events

    • 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.

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
-

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

  1. 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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