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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04891302

Enrollment

104

Registered

2021-05-18

Start date

2021-03-19

Completion date

2021-07-08

Last updated

2022-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

Keywords

Clevudine

Brief 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.

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

Inclusion criteria

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
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)
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)
The rate of subjects indicated by the improvement of lung invasive.	Within Day 29 (or EOT)
The cycle threshold values change from baseline.	Day 4, Day 8, Day 11, Day 15, Day 22 and Day29
The time consumed for clinical improvement.	Day 4, Day 8, Day 11, Day 15, Day 22 and Day 29 (or EOT)
The C-reactive protein change from baseline.	Day 4, Day 8, Day 11, Day 15, Day 22 and Day29
The procalcitonine change from baseline.	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.	Day 4, Day 8, Day 11, Day 15, Day 22 and Day 29 (or EOT)
The time of subjects discharged from the hospital.	Day 4, Day 8, Day 11, Day 15, Day 22 and Day 29 (or EOT)
The viral load change from baseline.	Day 4, Day 8, Day 11, Day 15, Day 22 and Day29

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026