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.
7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.
This study's enrollment of 64 is below the median of 102 across 4,364 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Bukwang Pharmaceutical is the lead sponsor of 34 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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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Studies of the drug tested here: Clevudine