To assess the efficacy and safety of FOY-305 in patients with SARS-CoV-2 infection (COVID-19) in a placebo-controlled, multicenter, double-blind, randomized, parallel-group comparative study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
155
Aichi Clinical Site 1
Tokoname, Aichi-ken, Japan
Chiba Clinical Site 1
Narita, Chiba, Japan
Time to SARS-CoV-2 negative test
Time to SARS-CoV-2 negative test as assessed by the local laboratory
Time frame: Up to 14 days
Time to SARS-CoV-2 negative test
Time to SARS-CoV-2 negative test as assessed by the central laboratory
Time frame: Up to 14 days
Proportion of subjects who test negative for SARS-CoV-2
Proportion of subjects who test negative for SARS-CoV-2 (as assessed by the local and central laboratories)
Time frame: Up to 14 days
Ordinal scale for severity
Ordinal scale for severity. The minimum score is 0: No clinical or virological evidence of infection, representing the better outcome, and the maximum value is 8: Death, representing the worse outcome.
Time frame: Up to 14 days
Proportion of subjects on mechanical ventilator
Proportion of subjects on mechanical ventilator
Time frame: Up to 14 days
Survival status (alive/death)
Proportion of subjects alive or death
Time frame: Up to 14 days
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Fukuoka Clinical Site 1
Ōkawa, Fukuoka, Japan
Ibaraki Clinical Site 1
Tsuchiura, Ibaraki, Japan
Ishikawa Clinical Site 1
Kanazawa, Ishikawa-ken, Japan
Kanagawa Clinical Site 3
Kawasaki, Kanagawa, Japan
Kanagawa Clinical Site 1
Yokohama, Kanagawa, Japan
Kanagawa Clinical Site 2
Yokosuka, Kanagawa, Japan
Mie Clinical Site 1
Yokkaichi, Mie-ken, Japan
Niigata Clinical Site 1
Nagaoka, Niigata, Japan
...and 15 more locations