COLchicine Versus Ruxolitinib and Secukinumab in Open-label Prospective Randomized Trial in Patients With COVID-19 (COLORIT)

Lomonosov Moscow State University Medical Research and Educational Center

Status and phase: Completed; Phase 2

Conditions: COVID 19

Treatments: Drug: Colchicine; Drug: Secukinumab 150 MG/ML Subcutaneous Solution [COSENTYX]; Drug: Ruxolitinib 5 MG; Other: standard therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04403243

MSU080520

Details and patient eligibility

About

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

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 4 patient groups

1. Colchicine

Experimental group

Description:

30 Patients with mild and severe COVID 19 Patients will get investigated therapy for ten days. Patients will be follow-up during 45 days after randomization

Treatment:

Drug: Colchicine

2. Ruxolitinib

Experimental group

Description:

10 Patients with mild and severe COVID 19 Patients will get investigated therapy for ten days. Patients will be follow-up during 45 days after randomization

Treatment:

Drug: Ruxolitinib 5 MG

3.Secukinumab

Experimental group

Description:

10 Patients with mild and severe COVID 19 Patients will get investigated therapy singly. Patients will be follow-up during 45 days after randomization

Treatment:

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

4.Standard treatment

Active Comparator group

Description:

-30 patients Patients with mild and severe COVID 19 Patients will get investigated therapy for ten days. Patients will be follow-up during 45 days after randomization

Treatment:

Other: standard therapy