Clinical trial NCT04403243: COLchicine Versus Ruxolitinib and Secukinumab in Open-label Prospective Randomized Trial in Patients With COVID-19
Official title: COLchicine Versus Ruxolitinib and Secukinumab in Open-label Prospective Randomized Trial in Patients With COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: COVID 19
Keywords: COVID 19
colchicine
ruxolitinib
secukinumab
Lead sponsor: Lomonosov Moscow State University Medical Research and Educational Center
Sponsor class: OTHER
First posted: 2020-05-27
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized 3:1:1:3 into four groups: colchicine, ruxolitinib, secukinumab, and control group
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: change from baseline in clinical assessment score COVID 19 (CAS COVID 19) Frame: baseline
timeFrame: baseline, day 12
Secondary outcomes:
measure: Combine endpoint: Time to death or mechanical ventilation
timeFrame: 45 days
measure: C-reactive protein
timeFrame: baseline, day 12, day 45
measure: D-dimer
timeFrame: baseline, day 12, day 45
measure: EuroQol Group. EQ-5D™
timeFrame: baseline, day 12, day 45
measure: exposure area on lung CT
timeFrame: baseline, day 12, day 45
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Lomonosov Moscow State University Medical Research and Educational Center
state: Moscow Region
Study officials:
References:
citation: Mikolajewska A, Fischer AL, Piechotta V, Mueller A, Metzendorf MI, Becker M, Dorando E, Pacheco RL, Martimbianco ALC, Riera R, Skoetz N, Stegemann M. Colchicine for the treatment of COVID-19. Cochrane Database Syst Rev. 2021 Oct 18;10(10):CD015045. doi: 10.1002/14651858.CD015045.