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NCT04500132 Clinical Trial

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

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04500132
Other study ID # EC-18-C201
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date May 28, 2020
Est. completion date February 15, 2021

Study information
Verified date February 2022
Source Enzychem Lifesciences Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Prevention of COVID-19 infection to severe pneumonea or ARDS

Recruitment information / eligibility
Status Completed
Enrollment 63
Est. completion date February 15, 2021
Est. primary completion date February 4, 2021
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• EC-18
EC-18 QD
• Placebo EC-18
Placebo EC-18 QD

Locations
Country Name City State
Korea, Republic of Chungbuk National University Hospital Cheongju-si

Sponsors (1)
Lead Sponsor Collaborator
Enzychem Lifesciences Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Rate of transition to ARDS 14 days after starting IP administration
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