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Phase 2, Multi-center, Randomized, Double-blind, Placebo- Controlled Study to Evaluate the Safety and Efficacy of EC-18 in COVID-19 Infection to Pneumonia

Trial Profile

Phase 2, Multi-center, Randomized, Double-blind, Placebo- Controlled Study to Evaluate the Safety and Efficacy of EC-18 in COVID-19 Infection to Pneumonia

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 12 Aug 2020

At a glance

  • Drugs Mosedipimod (Primary)
  • Indications Adult respiratory distress syndrome; COVID 2019 infections; Pneumonia
  • Focus Therapeutic Use
  • Sponsors Enzychem Lifesciences Corporation
  • Most Recent Events

    • 13 Jul 2020 Status changed from planning to recruiting, according to an Enzychem Lifesciences Corporation media release.
    • 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.

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

Rate of transition to ARDS

time_frame: 14 days after starting IP administration

Other Endpoints

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

Diseases Treated

Indication Qualifiers Patient Segments
Adult respiratory distress syndrome prevention -
COVID 2019 infections treatment -
Pneumonia treatment severe

Subjects

  • Subject Type patients
  • Number

    Planned: 60

  • Sex male & female
  • Age Group ≥ 19 years; adult

Patient Inclusion Criteria

- Signed informed consent - Male or female age 19 years or older - Pathologically confirmed diagnosis of COVID-19 Infection to Pneumonia

Patient Exclusion Criteria

- Pathologically confirmed diagnosis of bacterial pneumonia or viral pneumonia - Pregnant or nursing at the time of signing informed consent - Known sensitivity to any study medication - Unwilling or unable to complete study diary - Any other condition or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with the protocol

Trial Details

Identifiers

Identifier Owner
NCT04500132 ClinicalTrials.gov: US National Institutes of Health
EC18C201 -

Organisations

  • Sponsors Enzychem Lifesciences Corporation
  • Affiliations Enzychem Lifesciences Corporation

Trial Dates

  • Initiation Dates

    Actual : 28 May 2020

  • Primary Completion Dates

    Planned : 01 Aug 2021

  • End Dates

    Planned : 01 May 2022

Other Details

  • Design double-blind; multicentre; parallel; prospective; randomised
  • Phase of Trial Phase II
  • Location South Korea
  • Focus Therapeutic Use

Interventions

Drugs Route Formulation
MosedipimodPrimary Drug Oral
-

EC-18 Arm

EC-18 QD
Drug: EC-18 (EC-18 QD)

Placebo Arm

Placebo EC-18 QD
Drug: Placebo EC-18 (Placebo EC-18 QD)

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
Hyewon Jeong Chungbuk National University Hospital South-Korea

Centres

Centre Name Location Trial Centre Country
Chungbuk National University Hospital Cheongju-si South-Korea
Enzychem Lifesciences Corporation
Enzychem Lifescience
02-501-1084
safetypv@enzychem.com
show details
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Trial History

Event Date Event Type Comment
12 Aug 2020 Other trial event Last checked against the ClinicalTrials.gov: US National Institutes of Health record. Updated 12 Aug 2020
12 Aug 2020 Other trial event New source identified and integrated: ClinicalTrials.gov: US National Institutes of Health (NCT04500132). Updated 12 Aug 2020
13 Jul 2020 Status change - recruiting Status changed from planning to recruiting, according to an Enzychem Lifesciences Corporation media release. Updated 15 Jul 2020
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. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2016;.

    Available from: URL: http://clinicaltrials.gov
  3. 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
  4. Enzychem Lifesciences Corporation. Enzychem Lifesciences Files IND Application to FDA for Phase 2 Study of EC-18 in Preventing Acute Respiratory Distress Syndrome (ARDS) due to COVID-19 Pneumonia. Media-Rel 2020;.

    Media Release
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