v3.0.7
Please consider this website is continuously evolving and still under development
to harmonize automatic data extraction and integrate manual data annotation.
| Column | Value |
|---|---|
| Trial registration number | KCT0007426 |
|
Full text link
Last imported at : June 30, 2022, 4:30 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
https://cris.nih.go.kr/cris/search/detailSearchEn.do?seq=21762 |
|
First author
Last imported at : June 30, 2022, 4:30 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
|
|
Contact
Last imported at : June 30, 2022, 4:30 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
rsh515@hanmail.net |
|
Registration date
Last imported at : June 30, 2022, 4:30 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
2022-06-22 |
|
Recruitment status
Last imported at : June 30, 2022, 4:30 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Not recruiting |
|
Study design
Last imported at : June 30, 2022, 4:30 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
RCT |
|
Allocation
Last imported at : June 30, 2022, 4:30 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Randomized |
|
Design
Last imported at : June 30, 2022, 4:30 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Parallel |
|
Masking
Last imported at : June 30, 2022, 4:30 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Blind label |
|
Center
Last imported at : June 30, 2022, 4:30 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
multi-center |
|
Study aim
Last imported at : June 30, 2022, 4:30 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Treatment |
|
Inclusion criteria
Last imported at : June 30, 2022, 4:30 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
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
Last imported at : June 30, 2022, 4:30 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
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... |
|
Number of arms
Last imported at : June 30, 2022, 4:30 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
4 |
|
Funding
Last imported at : June 30, 2022, 4:30 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
GENENCELL |
|
Inclusion age min
Last imported at : June 30, 2022, 4:30 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
19 |
|
Inclusion age max
Last imported at : June 30, 2022, 4:30 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
100 |
|
Countries
Last imported at : June 30, 2022, 4:30 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Democratic People's Republic of Korea |
|
Type of patients
Last imported at : June 30, 2022, 4:30 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Mild/moderate disease at enrollment |
|
Severity scale
Last imported at : June 30, 2022, 4:30 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
2: Mild/moderate disease at enrollment |
|
Total sample size
Last imported at : June 30, 2022, 4:30 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
1130 |
|
primary outcome
Last imported at : June 30, 2022, 4:30 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Efficacy endpoints - first endpoints;Efficacy endpoints - Second endpoints |
|
Notes
Last imported at : June 30, 2022, 4:30 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
|
|
Phase
Last imported at : June 30, 2022, 4:30 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Phase 2/Phase 3 |
|
Arms
Last imported at : June 30, 2022, 4:30 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
[{"arm_notes": "480mg", "treatment_id": 2548, "treatment_name": "Dampalsu ethanol extract es16001", "treatment_type": "Vitamins and dietary supplements", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "720mg", "treatment_id": 2548, "treatment_name": "Dampalsu ethanol extract es16001", "treatment_type": "Vitamins and dietary supplements", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "960mg", "treatment_id": 2548, "treatment_name": "Dampalsu ethanol extract es16001", "treatment_type": "Vitamins and dietary supplements", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |