A Double-blind, Multi-center, Multi-regional, Randomized controlled, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of CKD-314 in Hospitalized Adult Patients Diagnosed with COVID-19
To evaluate the efficacy and safety of CKD-314 by comparing the study group and control group in hospitalized adult patients diagnosed with COVID-19 pneumonia
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
586
CKD-314 is administered intravenously and standard of care is also performed.
CKD-314 placebo is administered intravenously and standard of care is also performed..
Korea University Guro Hospital
Seoul, South Korea
RECRUITINGTime to recovery
Day of recovery is defined as the first day on which the subject meets the criteria
Time frame: From day1 to day 28
Time to clinical improvement: Time to clinical improvement (TTCI)
as time (days) from randomization to a decline of 2 categories on the 8-category ordinal scale of clinical status
Time frame: From day1 to day 28
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