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

NCT ID: NCT04500132

Last Updated: 2022-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-28

Study Completion Date

2021-02-15

Brief Summary

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Prevention of COVID-19 infection to severe pneumonea or ARDS

Detailed Description

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Conditions

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COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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EC-18 Arm

EC-18 QD

Group Type EXPERIMENTAL

EC-18

Intervention Type DRUG

EC-18 QD

Placebo Arm

Placebo EC-18 QD

Group Type PLACEBO_COMPARATOR

Placebo EC-18

Intervention Type DRUG

Placebo EC-18 QD

Interventions

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EC-18

EC-18 QD

Intervention Type DRUG

Placebo EC-18

Placebo EC-18 QD

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Enzychem Lifesciences Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hyewon Jeong

Role: PRINCIPAL_INVESTIGATOR

Chungbuk National University Hospital

Locations

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Chungbuk National University Hospital

Cheongju-si, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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EC-18-C201

Identifier Type: -

Identifier Source: org_study_id

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