The Proof of Concept Phase 2 Study to Evaluate the Safety and Efficacy of Clevudine in Patients With Mild and Moderate COVID-19
- Registration Number
- NCT04891302
- Lead Sponsor
- Bukwang Pharmaceutical
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 104
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Matching Placebo once a day for 10 days Clevudine Clevudine Clevudine 150 mg once a day for 10 days
- Primary Outcome Measures
Name Time Method The amount of SARS-CoV-2 virus reduction on Day 11 compared to the the baseline. Day 11
- Secondary Outcome Measures
Name Time Method 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 viral load change from baseline. Day 4, Day 8, Day 11, Day 15, Day 22 and Day29 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 indicated by the improvement of lung invasive. Within 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 cycle threshold values 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 C-reactive protein change from baseline. Day 4, Day 8, Day 11, Day 15, Day 22 and Day29 The time of subjects discharged from the hospital. Day 4, Day 8, Day 11, Day 15, Day 22 and Day 29 (or EOT)
Trial Locations
- Locations (11)
Korea University Ansan Hospital
🇰🇷Gyeonggi-do, Korea, Republic of
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
Myongji Hospital
🇰🇷Gyeonggi-do, Korea, Republic of
Incheon Medical Center
🇰🇷Incheon, Korea, Republic of
Kangnam Sacred Heart Hospital
🇰🇷Seoul, Korea, Republic of
Ajou University Hospital
🇰🇷Gyeonggi-do, Korea, Republic of
Gachon University Gil Medical Center
🇰🇷Incheon, Korea, Republic of
Chungnam National University Hospital
🇰🇷Daejeon, Korea, Republic of
Inha University Hospital
🇰🇷Incheon, Korea, Republic of
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
Seoul Medical Center
🇰🇷Seoul, Korea, Republic of