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Completed

NCT Number: NCT04347915

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

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Korea University Guro Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Clevudine

Drug

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

Placebo

Drug

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

Primary outcomes

  1. The rate of subjects tested as negative SARS-Coronavirus-2 (SARS-CoV-2)

    Time frame: within 15days

    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.

Secondary outcomes

  1. The rate of subjects tested as negative SARS-Coronavirus-2 (SARS-CoV-2) in consecutive two days of Real-Time RT-PCR tests

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

  2. The rate of subjects indicated by the improvement of lung invasive

    Time frame: within Day 29 (or EOT)

  3. The change of viral load

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

Sponsors and collaborators

Lead sponsor

Bukwang Pharmaceutical

Industry

Registry information

Official study title

A Single Blind, Randomized, Placebo-controlled, Multi-center Phase 2 Study to Evaluate the Safety and Efficacy of Clevudine in Patients Diagnosed With Moderate COVID-19

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 15, 2020
Registry last updated
Jul 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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