COVID-19
Conditions
Keywords
Coronavirus disease-19(COVID-19)
Brief summary
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.
Interventions
DRUGClevudine
Clevudine 120mg once a day for 14 days (up to 21 days)
DRUGPlacebo
Matching Placebo once a day for 14 days (up to 21 days)
Sponsors
Bukwang Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. Over 19 years of age 2. COVID-19 confirmed by a real-time RT-PCR tests 4 days prior to clinical trial enrollment 3. Patients with peripheral capillary oxygen saturation (SPO2) greater than 94% at the time of screening 4. 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.) 5. Patients with evidence of lung invasions as a result of radiation tests
Exclusion criteria
1. Patients who need breathing device (for example, Invasive ventilation, Invasive mechanical ventilation, Extra-corporeal membrane oxygenation). 2. Patients who participated in other clinical trials related to COVID-19. 3. Patients who were administered drugs directly to COVID-19 24 hours prior to the start of the study. 4. Patients whose AST or ALT has increased by more than 5 times the normal lab value.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The rate of subjects tested as negative SARS-Coronavirus-2 (SARS-CoV-2) | within 15days | 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. |
Secondary
| Measure | 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 |
Countries
South Korea
Outcome results
None listed