CompletedNCT04891302Updated Jul 22, 2022

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 interventional study of Clevudine and Placebo in COVID-19, sponsored by Bukwang Pharmaceutical. Completed at 11 sites in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2022-07-22.

Sponsored by Bukwang Pharmaceutical · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 104
Allocation: Randomized
Ages: 19 Years and older
Sex: All

Study 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.

Conditions studied

COVID-19

Browse trials for

COVID-19 7,633

Keywords

Clevudine

Who can participate

Ages eligible: 19 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Eligibility criteria

Key Inclusion Criteria:

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:

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.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 104 participants (actual)

Study arms

Experimental
Clevudine
Clevudine 150 mg once a day for 10 days
Drug: Clevudine
Placebo comparator
Placebo
Matching Placebo once a day for 10 days
Drug: Placebo

Interventions

DrugClevudine
Clevudine 150mg (5 capsules) once a day will be administered orally and can be taken regardless of food intake for 10 days
DrugPlacebo
Matching Placebo (5 capsules) once a day will be administered orally and can be taken regardless of food intake for 10 days

What researchers measure

Primary outcomes

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

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)

Study locations

11 sites

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

Registry details

Key details

Study ID: NCT04891302
Lead sponsor: Bukwang Pharmaceutical
Responsible party: Sponsor
First posted: May 18, 2021
Start date: Mar 19, 2021
Primary completion: Jul 5, 2021
Completion: Jul 8, 2021
Last update: Jul 22, 2022

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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