Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clevudine | Experimental | 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) |
|
| Placebo | Placebo Comparator | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clevudine | Drug | Clevudine 120mg once a day for 14 days (up to 21 days) |
| |
| 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 |
| 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 |
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Woo-Joo Kim, M.D.,Ph.D. | Korea University Guro Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Guro Hospital | Seoul | South Korea |
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C034935 | clevudine |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Drug |
Matching Placebo once a day for 14 days (up to 21 days) |
|
| within Day 29 (or EOT) |
| The change of viral load | Day 4, 8, 11, 15, 22, and 29(or EOT) comparing the baseline |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |