COLchicine Versus Ruxolitinib and Secukinumab In Open Prospective Randomized Trial

• Status: Recruiting
• Trial end date: 2020-08-23
• Target enrollment: 0
• Participant gender: All

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 get investigated therapy for 10 days. 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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lomonosov Moscow State University Medical Research and Educational Center
• Treatments: Colchicine

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