COVID-19Phase 2NCT04347915
The Phase 2 Study to Evaluate the Safety and Efficacy of Clevudine in Patients With Moderate COVID-19
A Phase 2 study testing Clevudine in people with COVID-19, run by Bukwang Pharmaceutical at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Clevudine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteSouth Korea
- Study dates
- 26 May 2020to 26 Feb 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- COVID-19
- Being tested
- Clevudine, Placebo
- Keywords
- Coronavirus disease-19(COVID-19)
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClevudineDrug
Clevudine 120mg once a day for 14 days (up to 21 days)
PlaceboDrug
Matching Placebo once a day for 14 days (up to 21 days)
| Study group | Role | What they receive |
|---|---|---|
| Clevudine | Experimental | 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) Receives: Drug: Clevudine |
| Placebo | Placebo comparator | 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) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within 15days
Secondary outcomes (3)
The rate of subjects tested as negative SARS-Coronavirus-2 (SARS-CoV-2) in consecutive two days of Real-Time RT-PCR tests
Measured: Day 4, 8, 11, 15, 22, 29(or EOT) day comparing the baseline
The rate of subjects indicated by the improvement of lung invasive
Measured: within Day 29 (or EOT)
The change of viral load
Measured: Day 4, 8, 11, 15, 22, and 29(or EOT) comparing the baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2020
- Study start26 May 2020
- Primary completion24 Feb 2021
- Study completion26 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bukwang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Woo-Joo Kim, M.D.,Ph.D., Principal investigator, Korea University Guro Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04347915
- Sponsor's protocol ID
- BK-CLV-201
- Status last verified
- Jul 2022
- First submitted
- 14 Apr 2020
- Last updated
- 22 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04347915
- Acronym / sponsor ID
- BK-CLV-201
- Conditions
- COVID-19
- Keywords
- Coronavirus disease-19(COVID-19)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Bukwang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 26 May 2020 (actual)
- Primary completion
- 24 Feb 2021 (actual)
- Study completion
- 26 Feb 2021 (actual)
- First posted
- 15 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clevudine | Experimental | Drug: ClevudineClevudine 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) |
| Placebo | Placebo comparator | Drug: PlaceboMatching 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) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.)
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ClevudineClevudine 120mg once a day for 14 days (up to 21 days) | Drug | Clevudine |
| PlaceboMatching Placebo once a day for 14 days (up to 21 days) | Drug | Placebo |
Primary outcome
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.
3 secondary outcomes
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
The rate of subjects indicated by the improvement of lung invasive
Time frame: within Day 29 (or EOT)
The change of viral load
Time frame: Day 4, 8, 11, 15, 22, and 29(or EOT) comparing the baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Woo-Joo Kim, M.D.,Ph.D. principal investigator
Korea University Guro Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Clevudine in people with COVID-19, run by Bukwang Pharmaceutical at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of subjects tested as negative SARS-Coronavirus-2 (SARS-CoV-2) (time frame: within 15days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2022.