To Evaluate Safety and Efficacy of EC-18 in COVID-19 Infe... | NCT04500132

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

NCT04500132

Sponsor

Enzychem Lifesciences Corporation

Status

Completed

Last Update Posted

Feb 10, 2022Actual

Enrollment

63Actual

Phase

Phase 2

Conditions

COVID-19

Interventions

EC-18
Placebo EC-18

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 28, 2020Actual

Primary Completion Date

Feb 4, 2021Actual

Completion Date

Feb 15, 2021Actual

First Submitted Date

Aug 4, 2020

First Submission Date that Met QC Criteria

Aug 4, 2020

First Posted Date

Aug 5, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 8, 2022

Last Update Posted Date

Feb 10, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

63Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
EC-18 Arm	Experimental	EC-18 QD	Drug: EC-18
Placebo Arm	Placebo Comparator	Placebo EC-18 QD	Drug: Placebo EC-18

Interventions

Name	Type	Description	Arm Group Labels	Other Names
EC-18	Drug	EC-18 QD	EC-18 Arm
Placebo EC-18

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rate of transition to ARDS		14 days after starting IP administration

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hyewon Jeong	Chungbuk National University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chungbuk National University Hospital		Cheongju-si			South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided