The Proof of Concept Phase 2 Study to Evaluate the Safety and Efficacy of Clevudine in Patients With Mild and Moderate COVID-19
Primary Purpose
COVID-19
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Clevudine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring Clevudine
Eligibility Criteria
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.
Sites / Locations
- Chungnam National University Hospital
- Ajou University Hospital
- Korea University Ansan Hospital
- Myongji Hospital
- Gachon University Gil Medical Center
- Incheon Medical Center
- Inha University Hospital
- Kangnam Sacred Heart Hospital
- Korea University Anam Hospital
- Korea University Guro Hospital
- Seoul Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Clevudine
Placebo
Arm Description
Clevudine 150 mg once a day for 10 days
Matching Placebo once a day for 10 days
Outcomes
Primary Outcome Measures
The amount of SARS-CoV-2 virus reduction on Day 11 compared to the the baseline.
Secondary Outcome Measures
The time consumed for clinical improvement.
The rate of subjects tested as negative SARS-CoV-2 in consecutive two days of Real-Time RT-PCR tests.
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.
The rate of subjects indicated by the improvement of lung invasive.
The cycle threshold values change from baseline.
The viral load change from baseline.
The C-reactive protein change from baseline.
The procalcitonine change from baseline.
The rate of subjects who received new oxygen supplement at visit after baseline.
The time of subjects discharged from the hospital.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04891302
Brief Title
The Proof of Concept Phase 2 Study to Evaluate the Safety and Efficacy of Clevudine in Patients With Mild and Moderate COVID-19
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
March 19, 2021 (Actual)
Primary Completion Date
July 5, 2021 (Actual)
Study Completion Date
July 8, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bukwang Pharmaceutical
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
Clevudine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
104 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Clevudine
Arm Type
Experimental
Arm Description
Clevudine 150 mg once a day for 10 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching Placebo once a day for 10 days
Intervention Type
Drug
Intervention Name(s)
Clevudine
Intervention Description
Clevudine 150mg (5 capsules) once a day will be administered orally and can be taken regardless of food intake for 10 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching Placebo (5 capsules) once a day will be administered orally and can be taken regardless of food intake for 10 days
Primary Outcome Measure Information:
Title
The amount of SARS-CoV-2 virus reduction on Day 11 compared to the the baseline.
Time Frame
Day 11
Secondary Outcome Measure Information:
Title
The time consumed for clinical improvement.
Time Frame
Day 4, Day 8, Day 11, Day 15, Day 22 and Day 29 (or EOT)
Title
The rate of subjects tested as negative SARS-CoV-2 in consecutive two days of Real-Time RT-PCR tests.
Time Frame
Day 4, Day 8, Day 11, Day 15, Day 22 and Day 29 (or EOT)
Title
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.
Time Frame
Day 4, Day 8, Day 15, Day 22 and Day29 (or EOT)
Title
The rate of subjects indicated by the improvement of lung invasive.
Time Frame
Within Day 29 (or EOT)
Title
The cycle threshold values change from baseline.
Time Frame
Day 4, Day 8, Day 11, Day 15, Day 22 and Day29
Title
The viral load change from baseline.
Time Frame
Day 4, Day 8, Day 11, Day 15, Day 22 and Day29
Title
The C-reactive protein change from baseline.
Time Frame
Day 4, Day 8, Day 11, Day 15, Day 22 and Day29
Title
The procalcitonine change from baseline.
Time Frame
Day 4, Day 8, Day 11, Day 15, Day 22 and Day29
Title
The rate of subjects who received new oxygen supplement at visit after baseline.
Time Frame
Day 4, Day 8, Day 11, Day 15, Day 22 and Day 29 (or EOT)
Title
The time of subjects discharged from the hospital.
Time Frame
Day 4, Day 8, Day 11, Day 15, Day 22 and Day 29 (or EOT)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Chungnam National University Hospital
City
Daejeon
Country
Korea, Republic of
Facility Name
Ajou University Hospital
City
Gyeonggi-do
Country
Korea, Republic of
Facility Name
Korea University Ansan Hospital
City
Gyeonggi-do
Country
Korea, Republic of
Facility Name
Myongji Hospital
City
Gyeonggi-do
Country
Korea, Republic of
Facility Name
Gachon University Gil Medical Center
City
Incheon
Country
Korea, Republic of
Facility Name
Incheon Medical Center
City
Incheon
Country
Korea, Republic of
Facility Name
Inha University Hospital
City
Incheon
Country
Korea, Republic of
Facility Name
Kangnam Sacred Heart Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Korea University Anam Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Korea University Guro Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul Medical Center
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
The Proof of Concept Phase 2 Study to Evaluate the Safety and Efficacy of Clevudine in Patients With Mild and Moderate COVID-19
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