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To Evaluate Safety and Efficacy of EC-18 in COVID-19 Infection to Pneumonia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04500132
Recruitment Status : Recruiting
First Posted : August 5, 2020
Last Update Posted : August 6, 2020
Sponsor:
Information provided by (Responsible Party):
Enzychem Lifesciences Corporation

Brief Summary:
Prevention of COVID-19 infection to severe pneumonea or ARDS

Condition or disease Intervention/treatment Phase
COVID-19 Drug: EC-18 Drug: Placebo EC-18 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : May 28, 2020
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
Experimental: EC-18 Arm
EC-18 QD
Drug: EC-18
EC-18 QD

Placebo Comparator: Placebo Arm
Placebo EC-18 QD
Drug: Placebo EC-18
Placebo EC-18 QD




Primary Outcome Measures :
  1. Rate of transition to ARDS [ Time Frame: 14 days after starting IP administration ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04500132


Contacts
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Contact: Enzychem Lifescience 02-501-1084 safetypv@enzychem.com

Locations
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Korea, Republic of
Chungbuk National University Hospital Recruiting
Cheongju-si, Korea, Republic of
Sponsors and Collaborators
Enzychem Lifesciences Corporation
Investigators
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Principal Investigator: Hyewon Jeong Chungbuk National University Hospital
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Responsible Party: Enzychem Lifesciences Corporation
ClinicalTrials.gov Identifier: NCT04500132    
Other Study ID Numbers: EC-18-C201
First Posted: August 5, 2020    Key Record Dates
Last Update Posted: August 6, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections