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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-19

Study Completion Date

2021-07-08

Brief Summary

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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.

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Detailed Description

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Conditions

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COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Clevudine

Clevudine 150 mg once a day for 10 days

Group Type EXPERIMENTAL

Clevudine

Intervention Type DRUG

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

Placebo

Matching Placebo once a day for 10 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Clevudine

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

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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.

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.

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No