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

A Single Blind, Randomized, Placebo-controlled, Multi-center Phase 2 Study to Evaluate the Safety and Efficacy of Clevudine in Patients Diagnosed With Moderate COVID-19

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.

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Drug: Clevudine; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Korea University Guro Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Key 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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)	Drug: Clevudine; Clevudine 120mg once a day for 14 days (up to 21 days)
PLACEBO_COMPARATOR: 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)	Drug: Placebo; Matching Placebo once a day for 14 days (up to 21 days)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The rate of subjects tested as negative SARS-Coronavirus-2 (SARS-CoV-2)	The primary efficacy endpoint for this clinical trial is the rate of patients with negative SARS-Coronavirus-2 (SARS-CoV-2) in a two-day continuous Real-Time-RT-PCR test from baseline to before the 15th day.	within 15days

Secondary Outcome Measures

Outcome Measure	Time Frame
The rate of subjects tested as negative SARS-Coronavirus-2 (SARS-CoV-2) in consecutive two days of Real-Time RT-PCR tests	Day 4, 8, 11, 15, 22, 29(or EOT) day comparing the baseline
The rate of subjects indicated by the improvement of lung invasive	within Day 29 (or EOT)
The change of viral load	Day 4, 8, 11, 15, 22, and 29(or EOT) comparing the baseline

Collaborators and Investigators

• Sponsor: Bukwang Pharmaceutical
• Investigators: Principal Investigator: Woo-Joo Kim, M.D.,Ph.D., Korea University Guro Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 26, 2020
• Primary Completion (ACTUAL): February 24, 2021
• Study Completion (ACTUAL): February 26, 2021

Study Registration Dates

• First Submitted: April 14, 2020
• First Submitted That Met QC Criteria: April 14, 2020
• First Posted (ACTUAL): April 15, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 22, 2022
• Last Update Submitted That Met QC Criteria: July 20, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Coronavirus disease-19(COVID-19)
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Anti-Infective Agents; Antiviral Agents; Clevudine
• Other Study ID Numbers: BK-CLV-201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No