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

Phase 2

Completed

• Conditions: COVID 19
• Interventions: Drug: Ruxolitinib 5 MG; Other: standard therapy; Drug: Secukinumab 150 MG/ML Subcutaneous Solution [COSENTYX]; Drug: Colchicine

• Registration Number: NCT04403243
• Lead Sponsor: Lomonosov Moscow State University Medical Research and Educational Center

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-08
• Study First Submitted: 2020-05-20
• Study First Submitted QC: 2020-05-26
• Study First Posted: 2020-05-27
• Primary Completion: 2020-07-22
• Study Completion: 2020-08-23
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-21
• Last Update Posted: 2022-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2. Ruxolitinib	Ruxolitinib 5 MG	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
4.Standard treatment	standard therapy	-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
3.Secukinumab	Secukinumab 150 MG/ML Subcutaneous Solution [COSENTYX]	10 Patients with mild and severe COVID 19 Patients will get investigated therapy singly. Patients will be follow-up during 45 days after randomization
1. Colchicine	Colchicine	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

Primary Outcome Measures

Name	Time	Method
change from baseline in clinical assessment score COVID 19 (CAS COVID 19) Frame: baseline	baseline, day 12	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

Secondary Outcome Measures

Name	Time	Method
D-dimer	baseline, day 12, day 45	Change from baseline in D-dimer
EuroQol Group. EQ-5D™	baseline, day 12, day 45	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.
Combine endpoint: Time to death or mechanical ventilation	45 days	time to death or mechanical ventilation
C-reactive protein	baseline, day 12, day 45	Change from baseline in C-reactive protein
exposure area on lung CT	baseline, day 12, day 45	Change from baseline in exposure area on lung CT

Trial Locations

Locations (1)

Lomonosov Moscow State University Medical Research and Educational Center; 🇷🇺 Moscow, Moscow Region, Russian Federation