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

Primary Purpose

COVID 19

Status
Completed
Phase
Phase 2
Locations
Russian Federation
Study Type
Interventional
Intervention
Colchicine
Ruxolitinib 5 MG
Secukinumab 150 MG/ML Subcutaneous Solution [COSENTYX]
standard therapy
Sponsored by
Lomonosov Moscow State University Medical Research and Educational Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID 19 focused on measuring COVID 19, colchicine, ruxolitinib, secukinumab

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Lomonosov Moscow State University Medical Research and Educational Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

1. Colchicine

2. Ruxolitinib

3.Secukinumab

4.Standard treatment

Arm 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

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

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

-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

Outcomes

Primary Outcome Measures

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: respiratory rate (< 18 - 0 point; 18-22 - 1 point; 23-26 - 2 point; >26 - 3 point) body temperature (35.5 - 37.0 - 0 point; < 35.5 - 1 point; 37.1 - 38.5 - 1 point; > 38.5 - 2 point) Sp02 without support oxygen (> 93% - 0 point; 90-93% - 1 point; < 90% - 2 point) ventilation (not required - 0 point; low-flow ventilation - 1 point; Non-invasive positive pressure ventilation - 2 point; mechanical ventilation - 3 point) C-reactive protein (> 10 - 0 point; 10-59 - 1 point; 60-120 - 2 point; > 120 - 3 point) d - dimer (< 0.51 - 0 point; 0.51 - 2.0 - 1 point; 2.01 - 5.0 - 2, > 5.0 - 3 point) 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

Secondary Outcome Measures

Combine endpoint: Time to death or mechanical ventilation
time to death or mechanical ventilation
C-reactive protein
Change from baseline in C-reactive protein
D-dimer
Change from baseline in D-dimer
EuroQol Group. EQ-5D™
Change from baseline in EQ-5D-3L™ The EQ-5D-3L essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-3L descriptive system comprises the 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box to the most appropriate statement. This decision results into a 1-digit number, . The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'. The VAS can be used as a quantitative measure of health outcome by patient's own judgement.
exposure area on lung CT
Change from baseline in exposure area on lung CT

Full Information

First Posted
May 20, 2020
Last Updated
November 21, 2022
Sponsor
Lomonosov Moscow State University Medical Research and Educational Center
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1. Study Identification

Unique Protocol Identification Number
NCT04403243
Brief Title
COLchicine Versus Ruxolitinib and Secukinumab in Open-label Prospective Randomized Trial in Patients With COVID-19
Acronym
COLORIT
Official Title
COLchicine Versus Ruxolitinib and Secukinumab in Open-label Prospective Randomized Trial in Patients With COVID-19
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
May 8, 2020 (Actual)
Primary Completion Date
July 22, 2020 (Actual)
Study Completion Date
August 23, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lomonosov Moscow State University Medical Research and Educational Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID 19
Keywords
COVID 19, colchicine, ruxolitinib, secukinumab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Patients will be randomized 3:1:1:3 into four groups: colchicine, ruxolitinib, secukinumab, and control group
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1. Colchicine
Arm Type
Experimental
Arm 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
Arm Title
2. Ruxolitinib
Arm Type
Experimental
Arm 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
Arm Title
3.Secukinumab
Arm Type
Experimental
Arm 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
Arm Title
4.Standard treatment
Arm Type
Active Comparator
Arm 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
Intervention Type
Drug
Intervention Name(s)
Colchicine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Ruxolitinib 5 MG
Intervention Description
Ruxolitinib - 5mg twice a day per os for ten days
Intervention Type
Drug
Intervention Name(s)
Secukinumab 150 MG/ML Subcutaneous Solution [COSENTYX]
Intervention Description
Secukinumab - 300mg subcutaneously singly
Intervention Type
Other
Intervention Name(s)
standard therapy
Intervention Description
standard therapy for COVID 19
Primary Outcome Measure Information:
Title
change from baseline in clinical assessment score COVID 19 (CAS COVID 19) Frame: baseline
Description
CAS COVID 19 measures clinical and laboratory parameters in 7 domains: respiratory rate (< 18 - 0 point; 18-22 - 1 point; 23-26 - 2 point; >26 - 3 point) body temperature (35.5 - 37.0 - 0 point; < 35.5 - 1 point; 37.1 - 38.5 - 1 point; > 38.5 - 2 point) Sp02 without support oxygen (> 93% - 0 point; 90-93% - 1 point; < 90% - 2 point) ventilation (not required - 0 point; low-flow ventilation - 1 point; Non-invasive positive pressure ventilation - 2 point; mechanical ventilation - 3 point) C-reactive protein (> 10 - 0 point; 10-59 - 1 point; 60-120 - 2 point; > 120 - 3 point) d - dimer (< 0.51 - 0 point; 0.51 - 2.0 - 1 point; 2.01 - 5.0 - 2, > 5.0 - 3 point) 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
Time Frame
baseline, day 12
Secondary Outcome Measure Information:
Title
Combine endpoint: Time to death or mechanical ventilation
Description
time to death or mechanical ventilation
Time Frame
45 days
Title
C-reactive protein
Description
Change from baseline in C-reactive protein
Time Frame
baseline, day 12, day 45
Title
D-dimer
Description
Change from baseline in D-dimer
Time Frame
baseline, day 12, day 45
Title
EuroQol Group. EQ-5D™
Description
Change from baseline in EQ-5D-3L™ The EQ-5D-3L essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-3L descriptive system comprises the 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box to the most appropriate statement. This decision results into a 1-digit number, . The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'. The VAS can be used as a quantitative measure of health outcome by patient's own judgement.
Time Frame
baseline, day 12, day 45
Title
exposure area on lung CT
Description
Change from baseline in exposure area on lung CT
Time Frame
baseline, day 12, day 45

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Lomonosov Moscow State University Medical Research and Educational Center
City
Moscow
State/Province
Moscow Region
ZIP/Postal Code
119620
Country
Russian Federation

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
4 month
IPD Sharing Access Criteria
Medical professionals By the request
Citations:
PubMed Identifier
34658014
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.
Results Reference
derived

Learn more about this trial

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

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