Patients with mild and severe coronavirus disease 2019 (COVID 19) will be randomized 3:1:1:3 into four groups: colchicine, ruxolitinib, secukinumab, and control groups. . Patients will be follow-up during 45 days after randomization. Change in clinical assessment score COVID 19 (CAS COVID 19) between baseline and 12th day will be evaluated as the primary endpoint. Risk of death or mechanical ventilation during 45 days after randomization will also be assessed
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
70
0.5mg twice a day per os during the first three days and then 0.5mg daily per os if weight \< 86 kg or 0.5mg twice a day per os if weight \> 85kg for seven days.
Ruxolitinib - 5mg twice a day per os for ten days
Secukinumab - 300mg subcutaneously singly
standard therapy for COVID 19
Lomonosov Moscow State University Medical Research and Educational Center
Moscow, Moscow Oblast, Russia
change from baseline in clinical assessment score COVID 19 (CAS COVID 19) Frame: baseline
CAS COVID 19 measures clinical and laboratory parameters in 7 domains: 1. respiratory rate (\< 18 - 0 point; 18-22 - 1 point; 23-26 - 2 point; \>26 - 3 point) 2. body temperature (35.5 - 37.0 - 0 point; \< 35.5 - 1 point; 37.1 - 38.5 - 1 point; \> 38.5 - 2 point) 3. Sp02 without support oxygen (\> 93% - 0 point; 90-93% - 1 point; \< 90% - 2 point) 4. ventilation (not required - 0 point; low-flow ventilation - 1 point; Non-invasive positive pressure ventilation - 2 point; mechanical ventilation - 3 point) 5. C-reactive protein (\> 10 - 0 point; 10-59 - 1 point; 60-120 - 2 point; \> 120 - 3 point) 6. d - dimer (\< 0.51 - 0 point; 0.51 - 2.0 - 1 point; 2.01 - 5.0 - 2, \> 5.0 - 3 point) 7. exposure area on lung CT (no pneumonia - 0; 1-24% - 1 point; 25-50% - 2; 51-75% - 3, \> 75% - 4). Minimal number of points - 0; max - 20. Lower the score-better health
Time frame: baseline, day 12
Combine endpoint: Time to death or mechanical ventilation
time to death or mechanical ventilation
Time frame: 45 days
C-reactive protein
Change from baseline in C-reactive protein
Time frame: baseline, day 12, day 45
D-dimer
Change from baseline in D-dimer
Time frame: baseline, day 12, day 45
EuroQol Group. EQ-5D™
Change from baseline in EQ-5D-3L™ The EQ-5D-3L essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-3L descriptive system comprises the 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box to the most appropriate statement. This decision results into a 1-digit number, . The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'. The VAS can be used as a quantitative measure of health outcome by patient's own judgement.
Time frame: baseline, day 12, day 45
exposure area on lung CT
Change from baseline in exposure area on lung CT
Time frame: baseline, day 12, day 45
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