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

GENENCE0 个研究点目标入组 1,130 人开始时间: 待定最近更新: 2022年6月27日

适应症

试验速览

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•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

•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

发起方

GENENCE