Bukwang Pharm said it would modify the clinical trial design on Levovir (clevudine), an antiviral treatment, against the new coronavirus. Bukwang was the first local drugmaker to win approval for a trial on a Covid-19 treatment candidate.
|Bukwang Pharm plans to change the clinical trial design of its Covid-19 treatment candidate, Levovir. (Bukwang)|
Bukwang said it decided to exclude the control drug hydroxychloroquine from the study due to the recent controversy on its efficacy and safety.
The trial will compare Levovir with placebo, instead of hydroxychloroquine. In the initial design, the company had planned to evenly divide patients into the clevudine group and the hydroxychloroquine group. However, the modified design assigned the clevudine group and the placebo group in a 2:1 ratio.
The trial will be single-blind so that patients do not know which treatment they are receiving until the study is over. The trial will take place at eight hospitals.
“We expect that the modification of the clinical design will expedite the progress of the study. The overall schedule is subject to change depending on changes in the number of Covid-19 patients,” an official at Bukwang said.
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