A clinical study to evaluate the efficacy and safety of ES16001 after oral administration in COVID-19 patients

Efficacy and safety of ES16001 in patients with COVID-19: a phase II/III, multinational, randomized, parallel-group, double-blind, placebo-controlled study

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CRIS

Registry ID

KCT0007426

Enrollment

1130

Registered

2022-06-22

Start date

2022-04-29

Completion date

Unknown

Last updated

2022-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Drug Name: ES16001 Target: COVID-19 Patients Phase 2: 424(1:1:1:1) Phase 3: 706(1:1) Dosage and administration methods -Phase 2 Cohort1: ES16001 480 mg, administered for 7 days Cohort2: ES160

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Those with full understanding of the clinical study and agreeing with the participation of the clinical study voluntarily in writing, or with a deputy granted with legal authority of the relevant patient if he/she is unable to agree with the clinical study in person 2. Adults aged at 19 or above at the time of screening examination (according to the legal age for adult in each country) 3. Diagnosis of COVID-19 including a positive RT-PCR for SARS-CoV-2 within 4 days prior to administering the IP 4. mild or moderate patients who have the following conditions at screening and confirm at randomization at randomization 5. etc...

Exclusion criteria

Exclusion criteria: An individual who meets any of the following criteria will be excluded from participation in this study: 1. Those with known or suspected hypersensitivity to ES16001 or any of its excipients 2. Those with genetic issues with galactose intolerance, lapp lactase deficiency, or glucose-galactose malabsorption, etc. 3. Patients with ECG evidence of a QTcF > 450 ms in men and > 470 ms in women and patients with any other risk factors for Torsades de pointes (TdP) (hypokalemia, hypomagnesemia or hypocalcemia, family history of long QT syndrome, low left ventricular ejection fraction, left ventricular hypertrophy, ischemia and slow heart rate) 4. Concomitant use of hydroxychloroquine or other drugs known to prolong QT interval throughout the study 5. etc...

Design outcomes

Primary

Measure	Time frame
Efficacy endpoints - first endpoints;Efficacy endpoints - Second endpoints	—

Secondary

Measure	Time frame
Efficacy endpoints - Second endpoints	—

Countries

Korea, Republic of

Contacts

Public ContactLee Sang Hak

The Catholic University of Korea, Eunpyeong St. Mary's Hospital

rsh515@hanmail.net+82-2-2030-4338

Outcome results