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

Phase 2

Completed

• Conditions: COVID-19
• Interventions: Drug: EC-18; Drug: Placebo EC-18

• Registration Number: NCT04500132
• Lead Sponsor: Enzychem Lifesciences Corporation

Brief Summary

Prevention of COVID-19 infection to severe pneumonea or ARDS

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-28
• Study First Submitted: 2020-08-04
• Study First Submitted QC: 2020-08-04
• Study First Posted: 2020-08-05
• Primary Completion: 2021-02-04
• Study Completion: 2021-02-15
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-08
• Last Update Posted: 2022-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EC-18 Arm	EC-18	EC-18 QD
Placebo Arm	Placebo EC-18	Placebo EC-18 QD

Primary Outcome Measures

Name	Time	Method
Rate of transition to ARDS	14 days after starting IP administration

Trial Locations

Locations (1)

Chungbuk National University Hospital; 🇰🇷 Cheongju-si, Korea, Republic of