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

Primary Purpose

COVID-19

Status

Completed

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Clevudine

Placebo

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring Coronavirus disease-19(COVID-19)

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

Over 19 years of age
COVID-19 confirmed by a real-time RT-PCR tests 4 days prior to clinical trial enrollment
Patients with peripheral capillary oxygen saturation (SPO2) greater than 94% at the time of screening
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.)
Patients with evidence of lung invasions as a result of radiation tests

Exclusion Criteria:

Patients who need breathing device (for example, Invasive ventilation, Invasive mechanical ventilation, Extra-corporeal membrane oxygenation).
Patients who participated in other clinical trials related to COVID-19.
Patients who were administered drugs directly to COVID-19 24 hours prior to the start of the study.
Patients whose AST or ALT has increased by more than 5 times the normal lab value.

Sites / Locations

Korea University Guro Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Clevudine

Placebo

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

The rate of subjects tested as negative SARS-Coronavirus-2 (SARS-CoV-2) in consecutive two days of Real-Time RT-PCR tests

The rate of subjects indicated by the improvement of lung invasive

The change of viral load

Full Information

NCT ID

NCT04347915

First Posted

April 14, 2020

Last Updated

July 20, 2022

Sponsor

Bukwang Pharmaceutical

1. Study Identification

Unique Protocol Identification Number

NCT04347915

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Completed

Study Start Date

May 26, 2020 (Actual)

Primary Completion Date

February 24, 2021 (Actual)

Study Completion Date

February 26, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bukwang Pharmaceutical

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19

Keywords

Coronavirus disease-19(COVID-19)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

64 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Clevudine

Arm Type

Experimental

Arm Description

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)

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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)

Intervention Type

Drug

Intervention Name(s)

Clevudine

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

The rate of subjects tested as negative SARS-Coronavirus-2 (SARS-CoV-2)

Description

Time Frame

within 15days

Secondary Outcome Measure Information:

Title

The rate of subjects tested as negative SARS-Coronavirus-2 (SARS-CoV-2) in consecutive two days of Real-Time RT-PCR tests

Time Frame

Day 4, 8, 11, 15, 22, 29(or EOT) day comparing the baseline

Title

The rate of subjects indicated by the improvement of lung invasive

Time Frame

within Day 29 (or EOT)

Title

The change of viral load

Time Frame

Day 4, 8, 11, 15, 22, and 29(or EOT) comparing the baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

Key Inclusion Criteria: Over 19 years of age COVID-19 confirmed by a real-time RT-PCR tests 4 days prior to clinical trial enrollment Patients with peripheral capillary oxygen saturation (SPO2) greater than 94% at the time of screening 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.) Patients with evidence of lung invasions as a result of radiation tests Exclusion Criteria: Patients who need breathing device (for example, Invasive ventilation, Invasive mechanical ventilation, Extra-corporeal membrane oxygenation). Patients who participated in other clinical trials related to COVID-19. Patients who were administered drugs directly to COVID-19 24 hours prior to the start of the study. Patients whose AST or ALT has increased by more than 5 times the normal lab value.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Woo-Joo Kim, M.D.,Ph.D.

Organizational Affiliation

Korea University Guro Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Korea University Guro Hospital

City

Seoul

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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