COVID-19 Clinical Trial
Official title:
Efficacy and Safety of ES16001 in Patients With COVID-19: a Phase II/III, Multinational, Randomized, Parallel-group, Double-blind, Placebo-controlled Study
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
After obtaining the consent and confirming eligibility, eligible patients will be treated with investigational medicinal product (IMP) for 7 days and followed up for additional 21 days (total 29 days). Patients who are discharged from the hospital or ending the quarantine may have to visit the investigational site on a pre-determined date for efficacy and safety follow up observation. Final safety and efficacy data will be collected on the last study day (29th Day). If patients are fully recovered or discharged from the hospital prior to treatment period, all the evaluations on the 7th day/End of Treatment examination treatment shall be performed on the day of discharging. ;
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