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Phase 2 multi-center, randomized, double-blind placebo-controlled study of EC-18 in preventing acute respiratory distress syndrome (ARDS) due to novel coronavirus pneumonia

Trial Profile

Phase 2 multi-center, randomized, double-blind placebo-controlled study of EC-18 in preventing acute respiratory distress syndrome (ARDS) due to novel coronavirus pneumonia

Status: Planning
Phase of Trial: Phase II

Latest Information Update: 14 May 2020

At a glance

  • Drugs Mosedipimod (Primary)
  • Indications COVID 2019 infections
  • Focus Adverse reactions
  • Most Recent Events

    • 14 May 2020 According to an Enzychem Lifesciences Corporation media release, the study will enroll patients at Chungbuk University Hospital and a number of institutions in South Korea.
    • 14 May 2020 According to an Enzychem Lifesciences Corporation media release, the Ministry of Food and Drug Safety (MFDS, formerly the Korea Food and Drug Administration), has accepted its Investigational New Drug (IND) application to initiate this study for EC-18 in Preventing Acute Respiratory Distress Syndrome (ARDS) due to novel coronavirus pneumonia.
    • 18 Mar 2020 New trial record

Trial Overview

Purpose

This phase 2 multi-center, randomized, double-blind placebo-controlled study will evaluate the safety and efficacy of EC-18 in preventing acute respiratory distress syndrome (ARDS) due to novel coronavirus pneumonia. Randomized patients will take EC-18 2000 mg or placebo daily for 14 days (30 patients on active arm, 30 patients on placebo). Safety and tolerability will be assessed on Days 7 and 14.

Primary Endpoints

Incidence of severe pneumonia or ARDS during a 14-day period

Other Endpoints

Cytokine level analysis and radiographic improvement of pneumonia. [1]

Diseases Treated

Indication Qualifiers Patient Segments
COVID 2019 infections treatment -

Subjects

  • Subject Type patients
  • Number

    Planned: 60

  • Sex male & female

Trial Details

Organisations

  • Affiliations Enzychem Lifesciences Corporation

Trial Dates

Other Details

  • Design double-blind; multicentre; prospective; randomised
  • Phase of Trial Phase II
  • Location South Korea
  • Focus Adverse reactions

Interventions

Drugs Route Formulation
MosedipimodPrimary Drug Oral
-

EC-18 (Mosedipimod)

Placebo

Trial History

Event Date Event Type Comment
14 May 2020 Other trial event According to an Enzychem Lifesciences Corporation media release, the study will enroll patients at Chungbuk University Hospital and a number of institutions in South Korea. Updated 19 May 2020
14 May 2020 Other trial event According to an Enzychem Lifesciences Corporation media release, the Ministry of Food and Drug Safety (MFDS, formerly the Korea Food and Drug Administration), has accepted its Investigational New Drug (IND) application to initiate this study for EC-18 in Preventing Acute Respiratory Distress Syndrome (ARDS) due to novel coronavirus pneumonia. Updated 19 May 2020
18 Mar 2020 New trial record New trial record Updated 18 Mar 2020
17 Mar 2020 Other trial event According to an Enzychem Lifesciences Corporation media release, the company announced that it is advancing a domestic clinical trial of EC-18, a new coronavirus treatment candidate, in South Korea. Updated 18 Mar 2020

References

  1. Enzychem Lifesciences Corporation. Enzychem Lifesciences Initiates Phase 2 Study for EC-18 in Preventing Acute Respiratory Distress Syndrome (ARDS) due to Novel Coronavirus Pneumonia. Media-Rel 2020;.

    Media Release
  2. Enzychem Lifesciences Corporation. Enzychem Lifesciences Announces Plans to Advance Clinical Trial in South Korea for EC-18 as a Potential Therapeutic for COVID-19 Infection. Media-Rel 2020;.

    Media Release
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