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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clevudine | Experimental | Clevudine 150 mg once a day for 10 days |
|
| Placebo | Placebo Comparator | Matching Placebo once a day for 10 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clevudine | Drug | Clevudine 150mg (5 capsules) once a day will be administered orally and can be taken regardless of food intake for 10 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| The amount of SARS-CoV-2 virus reduction on Day 11 compared to the the baseline. | Day 11 |
| 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) |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chungnam National University Hospital | Daejeon | South Korea | ||||
| Ajou University Hospital |
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| Placebo | Drug | Matching Placebo (5 capsules) once a day will be administered orally and can be taken regardless of food intake for 10 days |
|
| 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) |
| Gyeonggi-do |
| South Korea |
| Korea University Ansan Hospital | Gyeonggi-do | South Korea |
| Myongji Hospital | Gyeonggi-do | South Korea |
| Gachon University Gil Medical Center | Incheon | South Korea |
| Incheon Medical Center | Incheon | South Korea |
| Inha University Hospital | Incheon | South Korea |
| Kangnam Sacred Heart Hospital | Seoul | South Korea |
| Korea University Anam Hospital | Seoul | South Korea |
| Korea University Guro Hospital | Seoul | South Korea |
| Seoul Medical Center | Seoul | South Korea |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C034935 | clevudine |
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