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

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ClinicalTrials.gov Identifier: NCT04347915
Recruitment Status : Recruiting
First Posted : April 15, 2020
Last Update Posted : January 27, 2021
Sponsor:
Information provided by (Responsible Party):
Bukwang Pharmaceutical

Study Description
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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.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Clevudine Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Actual Study Start Date : May 6, 2020
Estimated Primary Completion Date : January 30, 2021
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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)


Outcome Measures
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Primary Outcome Measures :
  1. The rate of subjects tested as negative SARS-Coronavirus-2 (SARS-CoV-2) [ Time Frame: within 15days ]
    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 :
  1. 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 ]
  2. The rate of subjects indicated by the improvement of lung invasive [ Time Frame: within Day 29 (or EOT) ]
  3. The change of viral load [ Time Frame: Day 4, 8, 11, 15, 22, and 29(or EOT) comparing the baseline ]

Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04347915


Contacts
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Contact: Bukwang Bukwang +82-2-828-8114 bk.E106@bukwang.co.kr

Locations
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Korea, Republic of
Korea University Guro Hospital Recruiting
Seoul, Korea, Republic of
Sponsors and Collaborators
Bukwang Pharmaceutical
Investigators
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Principal Investigator: Woo-Joo Kim, M.D.,Ph.D. Korea University Guro Hospital
More Information
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Responsible Party: Bukwang Pharmaceutical
ClinicalTrials.gov Identifier: NCT04347915    
Other Study ID Numbers: BK-CLV-201
First Posted: April 15, 2020    Key Record Dates
Last Update Posted: January 27, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bukwang Pharmaceutical:
Coronavirus disease-19(COVID-19)
Additional relevant MeSH terms:
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Clevudine
Antiviral Agents
Anti-Infective Agents