This study is a multi-center, randomized, double-blind, parallel, placebo-controlled, phase Ⅱ clinical trial to evaluate efficacy and safety of Pyramax in mild to moderate COVID-19 patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
113
Pyramax
Placebo
Korea University Ansan Hospital
Ansan, South Korea
Chungnam national University Hospital
Daejeon, South Korea
Inha University Hospital
Incheon, South Korea
Proportion (%) of patients with virological clearance of SARS-CoV-2 at day 7 post-dose*
\* Patients who are rRT-PCR negative for COVID-19
Time frame: Day 7
Viral load reduction of SARS-CoV-2 at Day 3, 7, 10, and 14 post-dose compared to the baseline
Time frame: Day 3, 7, 10, 14
Proportion (%) of patients with virological clearance of SARS-CoV-2 at Day 3, 10, and 14 post-dose*
\* Patients who are rRT-PCR negative for COVID-19
Time frame: Day 3, 10, 14
Change in WHO Ordinal Scale for Clinical Improvement at Day 3, 7, 10, 14, and 28 post-dose from the baseline
Time frame: Day 3, 7, 10, 14, 28
Change in NEWS score at Day 3, 7, 10, 14, and 28 post-dose from the baseline
Time frame: Day 3, 7, 10, 14, 28
Time to achieve normalization of body temperature, post-dose
Time frame: Day 3, 7, 10, 14, 28
Time to achieve normalization of respiratory rate, post-dose
Time frame: Day 3, 7, 10, 14, 28
Time to achieve normalization of oxygen saturation, post-dose
Time frame: Day 3, 7, 10, 14, 28
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Gangnam Severance Hospital
Seoul, South Korea
Hallym University Kangnam Sacred Heart Hospital
Seoul, South Korea
Korea University Guro Hospital
Seoul, South Korea
Kyungpook National University Hospital
Seoul, South Korea
National Medical Center
Seoul, South Korea
Sahmyook Medical Center
Seoul, South Korea
Seoul Medical Center
Seoul, South Korea
...and 3 more locations