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Completed

NCT Number: NCT04891302

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

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.

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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

Chungnam National University Hospital, Daejeon, South Korea

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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, 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.

Treatment and study plan

Clevudine

Drug

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

Placebo

Drug

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

Primary outcomes

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

    Time frame: Day 11

Secondary outcomes

  1. The time consumed for clinical improvement.

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

  2. 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)

  3. 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)

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

    Time frame: Within Day 29 (or EOT)

  5. The cycle threshold values change from baseline.

    Time frame: Day 4, Day 8, Day 11, Day 15, Day 22 and Day29

  6. The viral load change from baseline.

    Time frame: Day 4, Day 8, Day 11, Day 15, Day 22 and Day29

  7. The C-reactive protein change from baseline.

    Time frame: Day 4, Day 8, Day 11, Day 15, Day 22 and Day29

  8. The procalcitonine change from baseline.

    Time frame: Day 4, Day 8, Day 11, Day 15, Day 22 and Day29

  9. 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)

  10. 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)

Sponsors and collaborators

Lead sponsor

Bukwang Pharmaceutical

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 18, 2021
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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