The Proof of Concept Phase 2 Study to Evaluate the Safety and Efficacy of Clevudine in Patients With Mild and Moderate COVID-19

Bukwang Pharmaceutical104 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

104

Conditions

COVID-19

Interventions

ClevudineDRUG

Clevudine 150mg (5 capsules) once a day will be administered orally and can be taken regardless of food intake for 10 days

PlaceboDRUG

Matching Placebo (5 capsules) once a day will be administered orally and can be taken regardless of food intake for 10 days

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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.

Locations (11)

Chungnam National University Hospital

Daejeon, South Korea

Ajou University Hospital

Gyeonggi-do, South Korea

Korea University Ansan Hospital

Gyeonggi-do, South Korea

Myongji Hospital

Outcomes

Primary Outcomes

The amount of SARS-CoV-2 virus reduction on Day 11 compared to the the baseline.

Time frame: Day 11

Secondary Outcomes

The time consumed for clinical improvement.

Time frame: Day 4, Day 8, Day 11, Day 15, Day 22 and Day 29 (or EOT)

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)

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)

The rate of subjects indicated by the improvement of lung invasive.

Time frame: Within Day 29 (or EOT)

The cycle threshold values change from baseline.

Time frame: Day 4, Day 8, Day 11, Day 15, Day 22 and Day29

The viral load change from baseline.

Time frame: Day 4, Day 8, Day 11, Day 15, Day 22 and Day29

The C-reactive protein change from baseline.

Time frame: Day 4, Day 8, Day 11, Day 15, Day 22 and Day29

The procalcitonine change from baseline.

Time frame: 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.

Time frame: Day 4, Day 8, Day 11, Day 15, Day 22 and Day 29 (or EOT)

Data from ClinicalTrials.gov

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