A Phase 2 interventional study of Clevudine and Placebo in COVID-19, sponsored by Bukwang Pharmaceutical. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2022-07-22.
Sponsored by Bukwang Pharmaceutical · Phase 2, Interventional, and Treatment
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.
Key Inclusion Criteria:
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.)
Exclusion Criteria:
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
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
Clevudine 120mg once a day for 14 days (up to 21 days)
Matching Placebo once a day for 14 days (up to 21 days)
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.
Time frame: within 15days
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
The rate of subjects indicated by the improvement of lung invasive
Time frame: within Day 29 (or EOT)
The change of viral load
Time frame: Day 4, 8, 11, 15, 22, and 29(or EOT) comparing the baseline
This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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Bukwang Pharmaceutical