The Proof of Concept Phase 2 Study to Evaluate the Safety and Efficacy of Clevudine in Patients With Mild and 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 150 mg versus placebo once daily administration with standard of care therapy for 10 days in patients with mild and moderate COVID-19.

Official Title
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A Double Blind, Randomized, Placebo-controlled, Multi-center, Proof of Concept Phase 2 Study to Evaluate the Safety and Efficacy of Clevudine in Patients Diagnosed With Mild and 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, and hospitalized Patients who experienced first symptom related to COVID-19 within 7days prior to enrollment and confirmed 2 or more relative symptoms at the time of randomization. Patients with peripheral capillary oxygen saturation(SpO2) greater than 94% at the time of screening, who do not need supplemental oxygen therapy. Key Exclusion Criteria: Patients who participated in other clinical trials related to COVID-19 Patients who were administered drugs directly to COVID-19 24hours prior to the start of the study. Patients who need oxygen supply or breathing device (non-invasive mechanical ventilation(via mask)), mechanical ventilator requirement (via endotracheal tube or tracheostomy tube, ECMO requirement) at the time of screening or baseline 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clevudine<br>Clevudine 150 mg once a day for 10 days | Drug: Clevudine<br>* Clevudine 150mg (5 capsules) once a day will be administered orally and can be taken regardless of food intake for 10 days<br>|
| Placebo Comparator: Placebo<br>Matching Placebo once a day for 10 days | Drug: Placebo<br>* Matching Placebo (5 capsules) once a day will be administered orally and can be taken regardless of food intake for 10 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The amount of SARS-CoV-2 virus reduction on Day 11 compared to the the baseline. |  | Day 11 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The time consumed for clinical improvement. |  | Day 4, Day 8, Day 11, Day 15, Day 22 and Day 29 (or EOT) | 
| The rate of subjects tested as negative SARS-CoV-2 in consecutive two days of Real-Time RT-PCR tests. |  | Day 4, Day 8, Day 11, Day 15, Day 22 and Day 29 (or EOT) | 
| The amount of SARS-CoV-2 virus reduction on Day 4, Day 8, Day 15, Day 22 and Day 29 compared to the the baseline. |  | Day 4, Day 8, Day 15, Day 22 and Day29 (or EOT) | 
| The rate of subjects indicated by the improvement of lung invasive. |  | Within Day 29 (or EOT) | 
| The cycle threshold values change from baseline. |  | Day 4, Day 8, Day 11, Day 15, Day 22 and Day29 | 
| The viral load change from baseline. |  | Day 4, Day 8, Day 11, Day 15, Day 22 and Day29 | 
| The C-reactive protein change from baseline. |  | Day 4, Day 8, Day 11, Day 15, Day 22 and Day29 | 
| The procalcitonine change from baseline. |  | Day 4, Day 8, Day 11, Day 15, Day 22 and Day29 | 
| The rate of subjects who received new oxygen supplement at visit after baseline. |  | Day 4, Day 8, Day 11, Day 15, Day 22 and Day 29 (or EOT) | 
| The time of subjects discharged from the hospital. |  | Day 4, Day 8, Day 11, Day 15, Day 22 and Day 29 (or EOT) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Clevudine