The Phase 2 Study to Evaluate the Safety and Efficacy of Clevudine in Patients With Moderate COVID-19

Study Overview
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Brief Summary
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The purpose of this clinical trial is to assess the safety and efficacy of Clevudine 120 mg versus placebo once daily administration with standard of care therapy for 14 days (maximum up to 21 days) in patients with moderate COVID-19.

Official Title
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A Single Blind, Randomized, Placebo-controlled, Multi-center Phase 2 Study to Evaluate the Safety and Efficacy of Clevudine in Patients Diagnosed With Moderate COVID-19

Conditions
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COVID-19

Intervention / Treatment
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* Drug: Clevudine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Over 19 years of age COVID-19 confirmed by a real-time RT-PCR tests 4 days prior to clinical trial enrollment Patients with peripheral capillary oxygen saturation (SPO2) greater than 94% at the time of screening Patients whose body temperature is measured according to the measured area without taking a fever reducer during screening: [armpit of greater than 37.0 °C or an oral of greater than 37.2 °C; Patients with rectum greater than 37.6 °C or eardrum greater than 37.5 °C] (Notes: Although you take a fever reducer, you can still be enrolled in after investigator's judgement whether there is fever or not.) Patients with evidence of lung invasions as a result of radiation tests Exclusion Criteria: Patients who need breathing device (for example, Invasive ventilation, Invasive mechanical ventilation, Extra-corporeal membrane oxygenation). Patients who participated in other clinical trials related to COVID-19. Patients who were administered drugs directly to COVID-19 24 hours prior to the start of the study. Patients whose AST or ALT has increased by more than 5 times the normal lab value.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clevudine<br>Clevudine 120mg (4 capsules) once a day will be administered orally and can be taken regardless of food intake for 14 days (up to 21 days) | Drug: Clevudine<br>* Clevudine 120mg once a day for 14 days (up to 21 days)<br>|
| Placebo Comparator: Placebo<br>Matching Placebo (4 capsules) once a day will be administered orally and can be taken regardless of food intake for 14 days (up to 21 days) | Drug: Placebo<br>* Matching Placebo once a day for 14 days (up to 21 days)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of subjects tested as negative SARS-Coronavirus-2 (SARS-CoV-2) | The primary efficacy endpoint for this clinical trial is the rate of patients with negative SARS-Coronavirus-2 (SARS-CoV-2) in a two-day continuous Real-Time-RT-PCR test from baseline to before the 15th day. | within 15days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of subjects tested as negative SARS-Coronavirus-2 (SARS-CoV-2) in consecutive two days of Real-Time RT-PCR tests |  | Day 4, 8, 11, 15, 22, 29(or EOT) day comparing the baseline | 
| The rate of subjects indicated by the improvement of lung invasive |  | within Day 29 (or EOT) | 
| The change of viral load |  | Day 4, 8, 11, 15, 22, and 29(or EOT) comparing the baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronavirus disease-19(COVID-19)