COVID-19Phase 2NCT04891302
The Proof of Concept Phase 2 Study to Evaluate the Safety and Efficacy of Clevudine in Patients With Mild and Moderate COVID-19
A Phase 2 study testing Clevudine in people with COVID-19, run by Bukwang Pharmaceutical at 11 sites in South Korea.
Trial summary
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. 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
- 104 participants
- Where
- 11 sitesSouth Korea
- Study dates
- 19 Mar 2021to 8 Jul 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, and hospitalized
- 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.
- Patients with peripheral capillary oxygen saturation(SpO2) greater than 94% at the time of screening, who do not need supplemental oxygen therapy.
Who cannot join
- Patients who participated in other clinical trials related to COVID-19
- Patients who were administered drugs directly to COVID-19 24hours prior to the start of the study.
- 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
- Patients whose AST or ALT has increased by more than 5 times the normal lab value.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
South Korea11 sites
Chungnam National University Hospital
Daejeon
Ajou University Hospital
Gyeonggi-do
Korea University Ansan Hospital
Gyeonggi-do
Myongji Hospital
Gyeonggi-do
Gachon University Gil Medical Center
Incheon
Incheon Medical Center
Incheon
Inha University Hospital
Incheon
Kangnam Sacred Heart Hospital
Seoul
Korea University Anam Hospital
Seoul
Korea University Guro Hospital
Seoul
Seoul Medical Center
Seoul
About this study
Official title: 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.
- Conditions
- COVID-19
- Being tested
- Clevudine, Placebo
- Keywords
- Clevudine
- 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 150mg (5 capsules) once a day will be administered orally and can be taken regardless of food intake for 10 days
PlaceboDrug
Matching Placebo (5 capsules) once a day will be administered orally and can be taken regardless of food intake for 10 days
| Study group | Role | What they receive |
|---|---|---|
| Clevudine | Experimental | Clevudine 150 mg once a day for 10 days Receives: Drug: Clevudine |
| Placebo | Placebo comparator | Matching Placebo once a day for 10 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The amount of SARS-CoV-2 virus reduction on Day 11 compared to the the baseline.
Measured: Day 11
Secondary outcomes (10)
The time consumed for clinical improvement.
Measured: 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.
Measured: 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.
Measured: Day 4, Day 8, Day 15, Day 22 and Day29 (or EOT)
The rate of subjects indicated by the improvement of lung invasive.
Measured: Within Day 29 (or EOT)
The cycle threshold values change from baseline.
Measured: Day 4, Day 8, Day 11, Day 15, Day 22 and Day29
The viral load change from baseline.
Measured: Day 4, Day 8, Day 11, Day 15, Day 22 and Day29
The C-reactive protein change from baseline.
Measured: Day 4, Day 8, Day 11, Day 15, Day 22 and Day29
The procalcitonine change from baseline.
Measured: 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.
Measured: Day 4, Day 8, Day 11, Day 15, Day 22 and Day 29 (or EOT)
The time of subjects discharged from the hospital.
Measured: Day 4, Day 8, Day 11, Day 15, Day 22 and Day 29 (or EOT)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2021
- Study start19 Mar 2021
- Primary completion5 Jul 2021
- Study completion8 Jul 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bukwang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04891302
- Sponsor's protocol ID
- BK-CLV-203
- Status last verified
- Jul 2022
- First submitted
- 13 May 2021
- 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 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
- ClinicalTrials.gov ID
- NCT04891302
- Acronym / sponsor ID
- BK-CLV-203
- Conditions
- COVID-19
- Keywords
- Clevudine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Bukwang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 19 Mar 2021 (actual)
- Primary completion
- 5 Jul 2021 (actual)
- Study completion
- 8 Jul 2021 (actual)
- First posted
- 18 May 2021 (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 150 mg versus placebo once daily administration with standard of care therapy for 10 days in patients with mild and moderate COVID-19.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clevudine | Experimental | Drug: ClevudineClevudine 150 mg once a day for 10 days |
| Placebo | Placebo comparator | Drug: PlaceboMatching Placebo once a day for 10 days |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Over 19 years of age
- COVID-19 confirmed by a real-time RT-PCR tests, and hospitalized
- 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.
- 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 (4 listed)
- Patients who participated in other clinical trials related to COVID-19
- Patients who were administered drugs directly to COVID-19 24hours prior to the start of the study.
- 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
- 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 150mg (5 capsules) once a day will be administered orally and can be taken regardless of food intake for 10 days | Drug | Clevudine |
| PlaceboMatching Placebo (5 capsules) once a day will be administered orally and can be taken regardless of food intake for 10 days | Drug | Placebo |
Primary outcome
The amount of SARS-CoV-2 virus reduction on Day 11 compared to the the baseline.
Time frame: Day 11
10 secondary outcomes
The time consumed for clinical improvement.
Time frame: 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)
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)
The rate of subjects indicated by the improvement of lung invasive.
Time frame: 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
The viral load change from baseline.
Time frame: 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
The procalcitonine change from baseline.
Time frame: 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)
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)
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.
The record lists no contact. Use the official record to reach the sponsor.
11 sites 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 11 sites 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 4 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 11 sites 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 amount of SARS-CoV-2 virus reduction on Day 11 compared to the the baseline. (time frame: Day 11). 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.