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

COVID 19 Clinical Trial

— COLORIT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04403243
• Other study ID #: MSU080520
• Status: Completed
• Phase: Phase 2
• Start date: May 8, 2020
• Est. completion date: August 23, 2020

Study information

• Verified date: November 2022
• Source: Lomonosov Moscow State University Medical Research and Educational Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: August 23, 2020
• Est. primary completion date: July 22, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID 19
• COVID-19

Intervention

Drug:
• Colchicine
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.
• Ruxolitinib 5 MG
Ruxolitinib - 5mg twice a day per os for ten days
• Secukinumab 150 MG/ML Subcutaneous Solution [COSENTYX]
Secukinumab - 300mg subcutaneously singly

Other:
• standard therapy
standard therapy for COVID 19

Locations

Country	Name	City	State
Russian Federation	Lomonosov Moscow State University Medical Research and Educational Center	Moscow	Moscow Region

Sponsors (1)

Lead Sponsor	Collaborator
Lomonosov Moscow State University Medical Research and Educational Center

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	baseline, day 12
Secondary	Combine endpoint: Time to death or mechanical ventilation	time to death or mechanical ventilation	45 days
Secondary	C-reactive protein	Change from baseline in C-reactive protein	baseline, day 12, day 45
Secondary	D-dimer	Change from baseline in D-dimer	baseline, day 12, day 45
Secondary	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.	baseline, day 12, day 45
Secondary	exposure area on lung CT	Change from baseline in exposure area on lung CT	baseline, day 12, day 45