Skip to main content
OpenTrials
Completed

NCT Number: NCT04403243

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

COVID 19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Lomonosov Moscow State University Medical Research and Educational Center

Moscow, Moscow Oblast, 119620, Russia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Colchicine

Drug

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

Drug

Ruxolitinib - 5mg twice a day per os for ten days

Secukinumab 150 MG/ML Subcutaneous Solution [COSENTYX]

Drug

Secukinumab - 300mg subcutaneously singly

Standard therapy

Other

standard therapy for COVID 19

Primary outcomes

  1. change from baseline in clinical assessment score COVID 19 (CAS COVID 19) Frame: baseline

    Time frame: baseline, day 12

    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 outcomes

  1. Combine endpoint: Time to death or mechanical ventilation

    Time frame: 45 days

    time to death or mechanical ventilation

  2. C-reactive protein

    Time frame: baseline, day 12, day 45

    Change from baseline in C-reactive protein

  3. D-dimer

    Time frame: baseline, day 12, day 45

    Change from baseline in D-dimer

  4. EuroQol Group. EQ-5D™

    Time frame: 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.

  5. exposure area on lung CT

    Time frame: baseline, day 12, day 45

    Change from baseline in exposure area on lung CT

Sponsors and collaborators

Lead sponsor

Lomonosov Moscow State University Medical Research and Educational Center

Other

Registry information

Acronym: COLORIT

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 27, 2020
Registry last updated
Nov 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.