A multicenter, randomized, double-blind, placebo-controlled trial for hospitalized moderate COVID-19 patients
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
385
Chiba Aoba Municipal Hospital
Chiba, Japan
RECRUITINGTime to clinical improvement
Time to patient clinical improvement by 2 points on a 7-point ordinal scale
Time frame: From enrollment up to Day 28
Rate of clinical improvement
Rate at which patients show a clinical improvement by 2 points on a 7-point ordinal scale
Time frame: Day 1 to Day 10, 14 and 28
Rate of clinical deterioration
Rate at which patients show a clinical deterioration by 2 points on a 7-point ordinal scale
Time frame: Day 1 to Day 10, 14 and 28
Time to viral clearance
Time taken for patients to demonstrate negative RT-PCR test of SARS-CoV-2 in the samples taken from nasopharyngeal swabs
Time frame: From enrollment up to Day 28
Rate of viral clearance
The rate at which patients demonstrate negative RT-PCR test of SARS-CoV-2 in the samples taken from nasopharyngeal swabs
Time frame: Each Day from Day 1 up to Day 28
Change in viral load
Changes of SARS-CoV-2 viral loads in the samples of nasopharyngeal swabs
Time frame: Each Day from Day 1 up to Day 28
Mortality rate
Mortality rate
Time frame: At Day 28
Duration of hospital stay
Number of days the patient is in hospital
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Kamagaya General Hospital
Chiba, Japan
RECRUITINGNHO Chiba Medical Center
Chiba, Japan
RECRUITINGNHO Omuta National Hospital
Fukuoka, Japan
ACTIVE_NOT_RECRUITINGNHO Kasumigaura Medical Center
Ibaraki, Japan
RECRUITINGTsukuba Medical Center Foundation Tsukuba Medical Center Hospital
Ibaraki, Japan
ACTIVE_NOT_RECRUITINGKokankai Nippon Kokan Hospital
Kanagawa, Japan
RECRUITINGRakuwakai Otowa Hospital
Kyoto, Japan
RECRUITINGOkayama City General Medical Center Okayama City Hospital
Okayama, Japan
RECRUITINGOsaka Habikino Medical Center
Osaka, Japan
RECRUITING...and 12 more locations
Time frame: From enrollment up to Day 28
Time to resolution of symptoms
Time taken for patients to demonstrate a resolution of symptoms defined as a (National Early Warning Score 2) NEWS 2 of 0 maintained for 24hours
Time frame: From enrollment up to Day 28
Requirement of supplemental oxygen
Rate at which patients require supplemental oxygen
Time frame: From enrollment up to Day 28
Requirement of mechanical ventilation
Rate at which patients require mechanical ventilation (invasive or non-invasive)
Time frame: From enrollment up to Day 28
Rate of alive patients
Rate of patients alive without having to use invasive ventilator or ECMO
Time frame: At Day 28
Adverse events
Adverse event incidence, type and severity
Time frame: From enrollment up to Day 28