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
- 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.
Most Recent Events
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 |
-
|
ENU200 oral utilizing iClickCare®
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
-
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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