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A clinical trial of ARMS-I to prevent airborne transmission of coronavirus in caregivers working on the frontlines of the COVID-19 pandemic (ARMS-I COVID Study)

Trial Profile

A clinical trial of ARMS-I to prevent airborne transmission of coronavirus in caregivers working on the frontlines of the COVID-19 pandemic (ARMS-I COVID Study)

Status: Planning
Phase of Trial: Phase I

Latest Information Update: 06 Apr 2020

At a glance

  • Drugs Cetylpyridinium (Primary)
  • Indications COVID 2019 infections
  • Focus Therapeutic Use
  • Acronyms ARMS-I COVID
  • Most Recent Events

    • 06 Apr 2020 New trial record
    • 02 Apr 2020 According to an University Hospitals media release, the Cleveland Foundation has authorized $1 million in emergency funding to support a significant portion of this clinical trial from previously restricted health-related research grant dollars at the foundation.
    • 02 Apr 2020 According to an University Hospitals media release, if the trial is successful, UH will work closely with the FDA and other relevant authorities with the goal of swiftly securing the necessary approvals to manufacture the product in quantities necessary to broadly help protect health care workers on the frontline.

Trial Overview

Purpose

This study is designed to assess whether ARMS-I helps prevent airborne transmission of coronavirus and whether it reduces the symptoms of healthcare providers who have tested positive for the virus. The trial participants will include clinical staff who are directly caring for patients.

Diseases Treated

Indication Qualifiers Patient Segments
COVID 2019 infections prevention -

Subjects

  • Subject Type volunteers
  • Sex male & female

Trial Details

Organisations

  • Affiliations ARMS Pharmaceutical

Trial Dates

Other Details

  • Design crossover; multicentre; prospective; randomised
  • Phase of Trial Phase I
  • Location USA
  • Focus Therapeutic Use

Interventions

Drugs Route Formulation
CetylpyridiniumPrimary Drug Oral
-

Trial History

Event Date Event Type Comment
06 Apr 2020 New trial record New trial record Updated 06 Apr 2020
02 Apr 2020 Other trial event According to an University Hospitals media release, the Cleveland Foundation has authorized $1 million in emergency funding to support a significant portion of this clinical trial from previously restricted health-related research grant dollars at the foundation. Updated 06 Apr 2020
02 Apr 2020 Other trial event According to an University Hospitals media release, if the trial is successful, UH will work closely with the FDA and other relevant authorities with the goal of swiftly securing the necessary approvals to manufacture the product in quantities necessary to broadly help protect health care workers on the frontline. Updated 06 Apr 2020
02 Apr 2020 Other trial event According to an University Hospitals media release, the study will be conducted by the UH Clinical Research Center with Robert Salata, serving as the principal investigator. University Hospitals will serve as the coordinating site for the trial with other Northeast Ohio health systems participating as additional sites for recruitment. Updated 06 Apr 2020
02 Apr 2020 Other trial event According to an University Hospitals media release, UH research team has been working closely with the manufacturer, ARMS Pharmaceutical, as well as Case Western Reserve University, to get this trial quickly organized, funded, and ready for roll-out. They are expecting to begin the trial within two weeks. Updated 06 Apr 2020
02 Apr 2020 Other trial event According to an University Hospitals media release, it will lead a clinical trial that involves the administration of an investigational drug, ARMS-I, to its caregivers working on the frontlines of the COVID-19 pandemic. Updated 06 Apr 2020

References

  1. UH to launch clinical trial in the fight to protect clinicians against COVID-19. Media-Rel 2020;.

    Media Release
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