Clinical trial NCT04891302: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: COVID-19
Keywords: Clevudine
Lead sponsor: Bukwang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2021-05-18
Enrollment: 104
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Key Inclusion Criteria:

1. Over 19 years of age
2. COVID-19 confirmed by a real-time RT-PCR tests, and hospitalized
3. 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.
4. 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:

1. Patients who participated in other clinical trials related to COVID-19
2. Patients who were administered drugs directly to COVID-19 24hours prior to the start of the study.
3. 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
4. Patients whose AST or ALT has increased by more than 5 times the normal lab value.

Primary outcomes:
measure: The amount of SARS-CoV-2 virus reduction on Day 11 compared to the the baseline.
timeFrame: Day 11
Secondary outcomes:
measure: The time consumed for clinical improvement.
timeFrame: Day 4, Day 8, Day 11, Day 15, Day 22 and Day 29 (or EOT)
measure: The rate of subjects tested as negative SARS-CoV-2 in consecutive two days of Real-Time RT-PCR tests.
timeFrame: Day 4, Day 8, Day 11, Day 15, Day 22 and Day 29 (or EOT)
measure: 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.
timeFrame: Day 4, Day 8, Day 15, Day 22 and Day29 (or EOT)
measure: The rate of subjects indicated by the improvement of lung invasive.
timeFrame: Within Day 29 (or EOT)
measure: The cycle threshold values change from baseline.
timeFrame: Day 4, Day 8, Day 11, Day 15, Day 22 and Day29
measure: The viral load change from baseline.
timeFrame: Day 4, Day 8, Day 11, Day 15, Day 22 and Day29
measure: The C-reactive protein change from baseline.
timeFrame: Day 4, Day 8, Day 11, Day 15, Day 22 and Day29
measure: The procalcitonine change from baseline.
timeFrame: Day 4, Day 8, Day 11, Day 15, Day 22 and Day29
measure: The rate of subjects who received new oxygen supplement at visit after baseline.
timeFrame: Day 4, Day 8, Day 11, Day 15, Day 22 and Day 29 (or EOT)
measure: The time of subjects discharged from the hospital.
timeFrame: Day 4, Day 8, Day 11, Day 15, Day 22 and Day 29 (or EOT)
Other outcomes:
Locations:
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Ajou University Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Korea University Ansan Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Myongji Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Incheon
country: Korea, Republic of
facility: Incheon Medical Center
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Seoul
country: Korea, Republic of
facility: Kangnam Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul Medical Center
Study officials:
References: