COVID-19 Clinical Trial
Official title:
DAS181 for COVID-19: A Phase II Multicenter, Randomized, Placebo-Controlled, Double-Blind Study
It is a multicenter, randomized, placebo-controlled, double-blind study. The study population is defined as subjects diagnosed with lower respiratory tract COVID-19 who require supplemental oxygen ≥2 LPM at the time of randomization.
The first stage is randomized, double-blind study to confirm the optimal dose of the study.
Twenty-two (n=22) subjects with COVID-19 and clinically significant impairment of respiratory
function will be enrolled to evaluate the two dosing regimens (4.5mg-q.d or 4.5mg-b.i.d) of
DAS181. At the end of Stage 1, the Sponsor will evaluate the dose regimen based on the safety
and efficacy assessments of the data. An optimal dose will be selected to proceed to Stage 2.
The second stage is a randomized, placebo-controlled and double-blind study to expand
enrollment with an additional eighty-two (n=82) subjects to provide adequate power to
potentially demonstrate statistically significant therapeutic efficacy.
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