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Efficacy and Safety of ES16001 in Patients With COVID-19

NCT05525182 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 706

Last updated 2023-02-22

No results posted yet for this study

Summary

This is phase II/III, randomized, parallel-group, double-blind, placebo-controlled study. Patients must be at least 19 years of age (or according to the legal age for adult in each country) with confirmed mild or moderate COVID-19 tested positive with a real time reverse transcription polymerase chain reaction (RT-PCR) analysis of rhinopharynx samples. RT-PCR analysis of rhinopharynx samples must be \<4 days old prior to the study enrolment

Conditions

Interventions

DRUG

ES16001 40 mg

Composition: Elaeocarpus extract 40mg tablet

DRUG

ES16001 80 mg

Elaeocarpus extract 80 mg tablet

DRUG

ES16001 160 mg

Elaeocarpus extract 160 mg tablet

DRUG

Placebo

Placebo Tablet: Tablets for oral use indistinguishable from ES16001 in size, appearance, taste and smell

Sponsors & Collaborators

  • Genencell Co. Ltd.

    lead INDUSTRY

Principal Investigators

  • Jae-Hyun Park · Genencell

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-05
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • South Korea

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05525182 on ClinicalTrials.gov