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A Phase 3 in-home, self-dosing clinical trial of ENU200 in patients with asymptomatic, mild to moderate coronavirus infections utilizing iClickCare®

Trial Profile

A Phase 3 in-home, self-dosing clinical trial of ENU200 in patients with asymptomatic, mild to moderate coronavirus infections utilizing iClickCare®

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 09 Apr 2020

At a glance

  • Drugs ENU 200 (Primary)
  • Indications COVID 2019 infections
  • Focus Therapeutic Use
  • Most Recent Events

    • 09 Apr 2020 New trial record
    • 02 Apr 2020 According to an Ennaid Therapeutics media release, the company is currently in discussions with the FDA and other regulatory agencies around the world regarding the planned clinical trial, which if approved, could enable ENU200 to be available to patients in six to nine months.
    • 02 Apr 2020 According to an Ennaid Therapeutics media release, utilizing the FDA's emergency/compassionate use regulatory pathway, or the FDA's 505(b)(2) application process, the company believes it can quickly bring ENU200 to market by treating patients with COVID-19 in a Phase 3 in-home, self-dosing clinical trial of patients with asymptomatic, mild to moderate coronavirus infections utilizing their iClickCare secure clinical reporting software service to monitor the in-home trials.

Trial Overview

Purpose

This study will evaluate ENU200 in patients with asymptomatic, mild to moderate coronavirus infections utilizing iClickCare®.

Diseases Treated

Indication Qualifiers Patient Segments
COVID 2019 infections treatment -

Subjects

  • Subject Type patients
  • Sex male & female

Trial Details

Organisations

  • Affiliations Ennaid Therapeutics

Trial Dates

Other Details

  • Design prospective
  • Phase of Trial Phase III
  • Location Unknown
  • Focus Therapeutic Use

Interventions

Drugs Route Formulation
ENU 200Primary Drug Oral
-

Trial History

Event Date Event Type Comment
09 Apr 2020 New trial record New trial record Updated 09 Apr 2020
02 Apr 2020 Other trial event According to an Ennaid Therapeutics media release, the company is currently in discussions with the FDA and other regulatory agencies around the world regarding the planned clinical trial, which if approved, could enable ENU200 to be available to patients in six to nine months. Updated 09 Apr 2020
02 Apr 2020 Other trial event According to an Ennaid Therapeutics media release, utilizing the FDA's emergency/compassionate use regulatory pathway, or the FDA's 505(b)(2) application process, the company believes it can quickly bring ENU200 to market by treating patients with COVID-19 in a Phase 3 in-home, self-dosing clinical trial of patients with asymptomatic, mild to moderate coronavirus infections utilizing their iClickCare secure clinical reporting software service to monitor the in-home trials. Updated 09 Apr 2020

References

  1. Ennaid Therapeutics. Ennaid Therapeutics Announces Development of ENU200, A New Antiviral Therapeutic for the Treatment of COVID-19. Media-Rel 2020;.

    Media Release
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