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
- 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.
Most Recent Events
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 |
-
|
ARMS-I
Placebo
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
-
UH to launch clinical trial in the fight to protect clinicians against COVID-19. Media-Rel 2020;.
Media Release
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