Official Title
COLchicine Versus Ruxolitinib and Secukinumab in Open-label Prospective Randomized Trial in Patients With COVID-19
Brief Summary

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

Completed
COVID 19

Drug: Colchicine

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.

Drug: Ruxolitinib 5 MG

Ruxolitinib - 5mg twice a day per os for ten days

Drug: Secukinumab 150 MG/ML Subcutaneous Solution [COSENTYX]

Secukinumab - 300mg subcutaneously singly

Other: standard therapy

standard therapy for COVID 19

Eligibility Criteria

Inclusion Criteria:

- Signed inform consent

- COVID 19 with the mild and severe course. The diagnosis could be made with positive
polymerase chain reaction (PCR) (International Statistical Classification (ICD-10)
code - U07.1) and/or virus pneumonia in computer tomography (ICD 10 code - U07.2)

- Lung exposure on CT more than 25%

- Sp02 without supportive oxygen ≤ 93%

- C-reactive protein > 60 mg/l or elevation of C reactive protein 3 times in 8-14 days
after first symptoms

Exclusion Criteria:

- pregnancy and breastfeeding

- hypersensitivity to colchicine

- hypersensitivity to ruxolitinib

- hypersensitivity to secukinumab

- Known liver failure

- Glomerular filtration rate <20 ml/ min

- physician judgment that the patient will need mechanical ventilation in 24 hours

- QTc > 450 ms

- other indications for to colchicine, ruxolitinib, and secukinumab

- Chronic therapy with corticosteroids or immunosuppressive therapy

- Active cancer

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Russian Federation
Locations

Lomonosov Moscow State University Medical Research and Educational Center
Moscow, Moscow Region, Russian Federation

Lomonosov Moscow State University Medical Research and Educational Center
NCT Number
Keywords
COVID 19
Colchicine
ruxolitinib
secukinumab
MeSH Terms
COVID-19
Colchicine