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
Latest Information Update: 14 Feb 2022
At a glance
- Drugs Mosedipimod (Primary)
- Indications COVID-19 pneumonia; SARS-CoV-2 acute respiratory disease
- Focus Therapeutic Use
- Sponsors Enzychem Lifesciences Corporation
- 08 Feb 2022 Status changed from recruiting to completed.
- 08 Jan 2021 According to an Enzychem Lifesciences Corporation media release, the company expect to report results from this trial in the first half of this year.
- 13 Jul 2020 Status changed from planning to recruiting, according to an Enzychem Lifesciences Corporation media release.
Most Recent Events
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
Patient's Questionnare (Self-symptom evaluation) [1]
Diseases Treated
| Indication | Qualifiers | Patient Segments |
|---|---|---|
| COVID-19 pneumonia | treatment | severe |
| SARS-CoV-2 acute respiratory disease | prevention | - |
Subjects
- Subject Type patients
-
Number
Planned: 60
Actual: 63
- Sex male & female
- Age Group ≥ 19 years; adult; elderly
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 |
|---|---|
| KCT0005344 | Clinical Research Information Service (CriS) - Republic of Korea |
| 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
Actual : 04 Feb 2021
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End Dates
Planned : 01 May 2022
Actual : 15 Feb 2021
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 |
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|
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
show details
02-501-1084 safetypv@enzychem.com |
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Trial History
| Event Date | Event Type | Comment |
|---|---|---|
| 14 Feb 2022 | Other trial event | Last checked against the ClinicalTrials.gov: US National Institutes of Health record. Updated 14 Feb 2022 |
| 08 Feb 2022 | Status change - completed | Status changed from recruiting to completed. Updated 14 Feb 2022 |
| 08 Jan 2021 | Other trial event | According to an Enzychem Lifesciences Corporation media release, the company expect to report results from this trial in the first half of this year. Updated 13 Jan 2021 |
| 30 Nov 2020 | Other trial event | New source identified and integrated Korean Clinical Trials Registry (KCT0005344). Updated 30 Nov 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
-
Korean Clinical Trials Register. Trial-Reg 2016;.
Available from: URL: https://cris.nih.go.kr/cris/en/ -
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 -
ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2023;.
Available from: URL: http://clinicaltrials.gov -
Enzychem Lifesciences Corporation. Enzychem Lifesciences Presenting at Biotech Showcase Digital 2021. Media-Rel 2021;.
Media Release -
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 -
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
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