The Phase 2 Study to Evaluate the Safety and Efficacy of Clevudine in Patients With 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

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-26

Study Completion Date

2021-02-26

Brief Summary

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The purpose of this clinical trial is to assess the safety and efficacy of Clevudine 120 mg versus placebo once daily administration with standard of care therapy for 14 days (maximum up to 21 days) in patients with 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

SINGLE

Participants

Study Groups

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Clevudine

Clevudine 120mg (4 capsules) once a day will be administered orally and can be taken regardless of food intake for 14 days (up to 21 days)

Group Type EXPERIMENTAL

Clevudine

Intervention Type DRUG

Clevudine 120mg once a day for 14 days (up to 21 days)

Placebo

Matching Placebo (4 capsules) once a day will be administered orally and can be taken regardless of food intake for 14 days (up to 21 days)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching Placebo once a day for 14 days (up to 21 days)

Interventions

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Clevudine

Clevudine 120mg once a day for 14 days (up to 21 days)

Intervention Type DRUG

Placebo

Matching Placebo once a day for 14 days (up to 21 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 4 days prior to clinical trial enrollment
3. Patients with peripheral capillary oxygen saturation (SPO2) greater than 94% at the time of screening
4. Patients whose body temperature is measured according to the measured area without taking a fever reducer during screening:

\[armpit of greater than 37.0 °C or an oral of greater than 37.2 °C; Patients with rectum greater than 37.6 °C or eardrum greater than 37.5 °C\] (Notes: Although you take a fever reducer, you can still be enrolled in after investigator's judgement whether there is fever or not.)
5. Patients with evidence of lung invasions as a result of radiation tests

Exclusion Criteria

1. Patients who need breathing device (for example, Invasive ventilation, Invasive mechanical ventilation, Extra-corporeal membrane oxygenation).
2. Patients who participated in other clinical trials related to COVID-19.
3. Patients who were administered drugs directly to COVID-19 24 hours prior to the start of the study.
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