Status:
COMPLETED
COLchicine Versus Ruxolitinib and Secukinumab in Open-label Prospective Randomized Trial in Patients With COVID-19
Lead Sponsor:
Lomonosov Moscow State University Medical Research and Educational Center
Conditions:
COVID 19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 du...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 23 2020
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04403243
Start Date
May 8 2020
End Date
August 23 2020
Last Update
November 25 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Lomonosov Moscow State University Medical Research and Educational Center
Moscow, Moscow Oblast, Russia, 119620