NCT04891302

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for phase_2 covid19

Timeline
Completed

Started Mar 2021

Shorter than P25 for phase_2 covid19

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 19, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 13, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 18, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2021

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 8, 2021

Completed
Last Updated

July 22, 2022

Status Verified

July 1, 2022

Enrollment Period

4 months

First QC Date

May 13, 2021

Last Update Submit

July 20, 2022

Conditions

COVID-19

Keywords

Clevudine

Outcome Measures

Primary Outcomes (1)

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

    Day 11

Secondary Outcomes (10)

  • The time consumed for clinical improvement.

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

  • 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

  • +5 more secondary outcomes

Study Arms (2)

Clevudine

EXPERIMENTAL

Clevudine 150 mg once a day for 10 days

Drug: Clevudine

Placebo

PLACEBO COMPARATOR

Matching Placebo once a day for 10 days

Drug: Placebo

Interventions

ClevudineDRUG

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

Clevudine
PlaceboDRUG

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

Placebo

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Chungnam National University Hospital

Daejeon, South Korea

Location

Ajou University Hospital

Gyeonggi-do, South Korea

Location

Korea University Ansan Hospital

Gyeonggi-do, South Korea

Location

Myongji Hospital

Gyeonggi-do, South Korea

Location

Gachon University Gil Medical Center

Incheon, South Korea

Location

Incheon Medical Center

Incheon, South Korea

Location

Inha University Hospital

Incheon, South Korea

Location

Kangnam Sacred Heart Hospital

Seoul, South Korea

Location

Korea University Anam Hospital

Seoul, South Korea

Location

Korea University Guro Hospital

Seoul, South Korea

Location

Seoul Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

COVID-19

Interventions

clevudine

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2021

First Posted

May 18, 2021

Study Start

March 19, 2021

Primary Completion

July 5, 2021

Study Completion

July 8, 2021

Last Updated

July 22, 2022

Record last verified: 2022-07

Locations

KR(11)