COLchicine Versus Ruxolitinib and Secukinumab in Open-label Prospective Randomized Trial in Patients With COVID-19
COLORIT
1 other identifier
interventional
70
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2020
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 8, 2020
CompletedFirst Submitted
Initial submission to the registry
May 20, 2020
CompletedFirst Posted
Study publicly available on registry
May 27, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 22, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 23, 2020
CompletedNovember 25, 2022
November 1, 2022
3 months
May 20, 2020
November 21, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
change from baseline in clinical assessment score COVID 19 (CAS COVID 19) Frame: baseline
CAS COVID 19 measures clinical and laboratory parameters in 7 domains: 1. respiratory rate (\< 18 - 0 point; 18-22 - 1 point; 23-26 - 2 point; \>26 - 3 point) 2. body temperature (35.5 - 37.0 - 0 point; \< 35.5 - 1 point; 37.1 - 38.5 - 1 point; \> 38.5 - 2 point) 3. Sp02 without support oxygen (\> 93% - 0 point; 90-93% - 1 point; \< 90% - 2 point) 4. ventilation (not required - 0 point; low-flow ventilation - 1 point; Non-invasive positive pressure ventilation - 2 point; mechanical ventilation - 3 point) 5. C-reactive protein (\> 10 - 0 point; 10-59 - 1 point; 60-120 - 2 point; \> 120 - 3 point) 6. d - dimer (\< 0.51 - 0 point; 0.51 - 2.0 - 1 point; 2.01 - 5.0 - 2, \> 5.0 - 3 point) 7. exposure area on lung CT (no pneumonia - 0; 1-24% - 1 point; 25-50% - 2; 51-75% - 3, \> 75% - 4). Minimal number of points - 0; max - 20. Lower the score-better health
baseline, day 12
Secondary Outcomes (5)
Combine endpoint: Time to death or mechanical ventilation
45 days
C-reactive protein
baseline, day 12, day 45
D-dimer
baseline, day 12, day 45
EuroQol Group. EQ-5D™
baseline, day 12, day 45
exposure area on lung CT
baseline, day 12, day 45
Study Arms (4)
1. Colchicine
EXPERIMENTAL30 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
2. Ruxolitinib
EXPERIMENTAL10 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
3.Secukinumab
EXPERIMENTAL10 Patients with mild and severe COVID 19 Patients will get investigated therapy singly. Patients will be follow-up during 45 days after randomization
4.Standard treatment
ACTIVE COMPARATOR-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
Interventions
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.
Secukinumab - 300mg subcutaneously singly
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Lomonosov Moscow State University Medical Research and Educational Center
Moscow, Moscow Oblast, 119620, Russia
Related Publications (1)
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.
PMID: 34658014DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 20, 2020
First Posted
May 27, 2020
Study Start
May 8, 2020
Primary Completion
July 22, 2020
Study Completion
August 23, 2020
Last Updated
November 25, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- 4 month
- Access Criteria
- Medical professionals By the request