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

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04891302
• Other study ID #: BK-CLV-203
• Status: Completed
• Phase: Phase 2
• Start date: March 19, 2021
• Est. completion date: July 8, 2021

Study information

• Verified date: July 2022
• Source: Bukwang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: July 8, 2021
• Est. primary completion date: July 5, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Key Inclusion Criteria:

1. Over 19 years of age

2. COVID-19 confirmed by a real-time RT-PCR tests, and hospitalized

3. 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.

4. 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:

1. Patients who participated in other clinical trials related to COVID-19

2. Patients who were administered drugs directly to COVID-19 24hours prior to the start of the study.

3. 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

4. Patients whose AST or ALT has increased by more than 5 times the normal lab value.

Related Conditions & MeSH terms

• COVID-19

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	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

Sponsors (1)

Lead Sponsor	Collaborator
Bukwang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The amount of SARS-CoV-2 virus reduction on Day 11 compared to the the baseline.		Day 11
Secondary	The time consumed for clinical improvement.		Day 4, Day 8, Day 11, Day 15, Day 22 and Day 29 (or EOT)
Secondary	The rate of subjects tested as negative SARS-CoV-2 in consecutive two days of Real-Time RT-PCR tests.		Day 4, Day 8, Day 11, Day 15, Day 22 and Day 29 (or EOT)
Secondary	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.		Day 4, Day 8, Day 15, Day 22 and Day29 (or EOT)
Secondary	The rate of subjects indicated by the improvement of lung invasive.		Within Day 29 (or EOT)
Secondary	The cycle threshold values change from baseline.		Day 4, Day 8, Day 11, Day 15, Day 22 and Day29
Secondary	The viral load change from baseline.		Day 4, Day 8, Day 11, Day 15, Day 22 and Day29
Secondary	The C-reactive protein change from baseline.		Day 4, Day 8, Day 11, Day 15, Day 22 and Day29
Secondary	The procalcitonine change from baseline.		Day 4, Day 8, Day 11, Day 15, Day 22 and Day29
Secondary	The rate of subjects who received new oxygen supplement at visit after baseline.		Day 4, Day 8, Day 11, Day 15, Day 22 and Day 29 (or EOT)
Secondary	The time of subjects discharged from the hospital.		Day 4, Day 8, Day 11, Day 15, Day 22 and Day 29 (or EOT)