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

NCT04347915 | Completed Phase 2

• 1 other identifier: BK-CLV-201
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COVID-19

Keywords

Coronavirus disease-19(COVID-19)

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  Day 4, 8, 11, 15, 22, 29(or EOT) day comparing the baseline

• The rate of subjects indicated by the improvement of lung invasive

  within Day 29 (or EOT)

• The change of viral load

  Day 4, 8, 11, 15, 22, and 29(or EOT) comparing the baseline

Study Arms (2)

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)

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)

Drug: Placebo

Interventions

Clevudine DRUG

Clevudine 120mg once a day for 14 days (up to 21 days)

Clevudine

Placebo DRUG

Matching Placebo once a day for 14 days (up to 21 days)

Placebo

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bukwang Pharmaceutical: lead

Study Sites (1)

Korea University Guro Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

COVID-19

Interventions

clevudine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Woo-Joo Kim, M.D.,Ph.D.

  Korea University Guro Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2020
• First Posted: April 15, 2020
• Study Start: May 26, 2020
• Primary Completion: February 24, 2021
• Study Completion: February 26, 2021
• Last Updated: July 22, 2022

Record last verified: 2022-07

Locations

KR (1)