This study is designed for single-center, randomized, open label, standard therapy controlled. 60 COVID-19 subjects with a treatment period of 10 days and follow-up until 28 days after enrollment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Colchicine Tablets (Each tablet contains colchicine 0.5mg)
Standard therapy for COVID-19 according to the Novel Coronavirus Pneumonia Diagnosis and Treatment Plan (Trial 8th Edition)
Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality, China
Recovery rate of clinical symptoms (fever, cough, expectoration, chest tightness, shortness of breath, dyspnea) and virus negative conversion rate (RT-PCR) at day 7
Time frame: Day 7
Changes in the patients' clinical status through the WHO Clinical Progression Scale (scores 0-10) at day 7
The scale provides a measure of illness severity across a range from 0 (not infected) to 10 (dead)
Time frame: Day 7
Changes in the patients' clinical status through the WHO Clinical Progression Scale (scores 0-10) at day 10
The scale provides a measure of illness severity across a range from 0 (not infected) to 10 (dead)
Time frame: Day 10
Ventilator usage rate, usage time at day 7
Time frame: Day 7
Ventilator usage rate, usage time at day 10
Time frame: Day 10
Recovery rate and virus negative conversion rate (RT-PCR) of 10-day clinical symptoms (fever, cough, sputum expectoration, chest tightness, shortness of breath, dyspnea)
Time frame: Day 10
Time for the virus negative conversion (RT-PCR)
Time frame: Up to day 28
Time for observation in hospital
Time frame: Up to day 28
Length of hospital stay
Time frame: Up to day 28
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Number of days in the intensive care unit
Time frame: Up to day 28
Changes in inflammatory markers at day 7: C-reactive protein
Time frame: Day 7
Changes in inflammatory markers at day 10: C-reactive protein
Time frame: Day 10
Changes in inflammatory markers at day 7: TNF-alfa
Time frame: Day 7
Changes in inflammatory markers at day 10: TNF-alfa
Time frame: Day 10
Changes in inflammatory markers at day 7: IL-6
Time frame: Day 7
Changes in inflammatory markers at day 10: IL-6
Time frame: Day 10
Changes in inflammatory markers at day 7: IL-1β
Time frame: Day 7
Changes in inflammatory markers at day 10: IL-1β
Time frame: Day 10
Changes in severity markers at day 7: D-dimer
Time frame: Day 7
Changes in severity markers at day 10: D-dimer
Time frame: Day 10
Changes in myocardial damage at day 7: hs-cTn
Time frame: Day 7
Changes in myocardial damage at day 10: hs-cTn
Time frame: Day 10
Changes in myocardial damage at day 7: NT-proBNP
Time frame: Day 7
Changes in myocardial damage at day 10: NT-proBNP
Time frame: Day 10