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

July 20, 2022 updated by: Bukwang Pharmaceutical

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

104

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Daejeon, Korea, Republic of
        • Chungnam National University Hospital
      • Gyeonggi-do, Korea, Republic of
        • Ajou University Hospital
      • Gyeonggi-do, Korea, Republic of
        • Korea University Ansan Hospital
      • Gyeonggi-do, Korea, Republic of
        • Myongji Hospital
      • Incheon, Korea, Republic of
        • Inha University Hospital
      • Incheon, Korea, Republic of
        • Gachon University Gil Medical Center
      • Incheon, Korea, Republic of
        • Incheon Medical Center
      • Seoul, Korea, Republic of
        • Korea University Guro Hospital
      • Seoul, Korea, Republic of
        • Korea University Anam Hospital
      • Seoul, Korea, Republic of
        • Seoul Medical Center
      • Seoul, Korea, Republic of
        • KangNam Sacred Heart Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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, 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Clevudine
Clevudine 150 mg once a day for 10 days
Drug: Clevudine
Clevudine 150mg (5 capsules) once a day will be administered orally and can be taken regardless of food intake for 10 days
Placebo Comparator: Placebo
Matching Placebo once a day for 10 days
Drug: Placebo
Matching Placebo (5 capsules) once a day will be administered orally and can be taken regardless of food intake for 10 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The amount of SARS-CoV-2 virus reduction on Day 11 compared to the the baseline.
Time Frame: Day 11
Day 11

Secondary Outcome Measures

Outcome Measure
Time Frame
The time consumed for clinical improvement.
Time Frame: Day 4, Day 8, Day 11, Day 15, Day 22 and Day 29 (or EOT)
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)
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)
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)
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
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
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
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
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)
Day 4, Day 8, Day 11, Day 15, Day 22 and Day 29 (or EOT)
The time of subjects discharged from the hospital.
Time Frame: Day 4, Day 8, Day 11, Day 15, Day 22 and Day 29 (or EOT)
Day 4, Day 8, Day 11, Day 15, Day 22 and Day 29 (or EOT)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bukwang Pharmaceutical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 19, 2021

Primary Completion (Actual)

July 5, 2021

Study Completion (Actual)

July 8, 2021

Study Registration Dates

First Submitted

May 13, 2021

First Submitted That Met QC Criteria

May 17, 2021

First Posted (Actual)

May 18, 2021

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BK-CLV-203

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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