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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04347915
Recruitment Status : Recruiting
First Posted : April 15, 2020
Last Update Posted : May 11, 2020
Sponsor:
Information provided by (Responsible Party):
Bukwang Pharmaceutical

Brief Summary:
The purpose of this clinical trial is to assess the safety and efficacy of Clevudine 120 mg once a day for 14 days (maximum up to 21 days) and of Hydroxychloroquine 200mg twice a day for 14 days (maximum up to 21 days) of administration in patients with moderate COVID-19.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Randomized, Open, Phase 2 Study to Evaluate the Safety and Efficacy of Clevudine in Patients With Moderate COVID-19
Actual Study Start Date : May 6, 2020
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Clevudine Drug: Clevudine
Clevudine 120mg once a day for 14 days (up to 21 days)

Experimental: Hydroxychloroquine Drug: Hydroxychloroquine
Hydroxychloroquine for 200 mg twice a day for 14 days (up to 21 days)




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: 4th, 8th, 15th, and 22nd day after the baseline ]
  2. The rate of subjects indicated by the improvement of lung invasive [ Time Frame: within 29days ]
  3. The change of viral load [ Time Frame: 4th, 8th, 15th, 22nd, and 29th day after the baseline ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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.

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
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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: May 11, 2020
Last Verified: April 2020

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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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Hydroxychloroquine
Clevudine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents
Antiviral Agents