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COVID 19Phase 2COLORITNCT04403243

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

A Phase 2 study testing Colchicine, Ruxolitinib 5 MG and Secukinumab 150 MG/ML Subcutaneous Solution [COSENTYX] in people with COVID 19, run by Lomonosov Moscow State University Medical Research and Educational Center at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
COVID 19
What is being tested?
Colchicine, Ruxolitinib 5 MG and Secukinumab 150 MG/ML Subcutaneous Solution [COSENTYX]
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteRussia
Study dates
8 May 2020to 23 Aug 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • pregnancy and breastfeeding
  • hypersensitivity to colchicine
  • hypersensitivity to ruxolitinib
  • hypersensitivity to secukinumab
  • Known liver failure
  • Glomerular filtration rate <20 ml/ min
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Russia1 site

  • Lomonosov Moscow State University Medical Research and Educational Center

    Moscow, Moscow Oblast, 119620

Other trials in Russia

About this study

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

Conditions
COVID 19
Being tested
Colchicine, Ruxolitinib 5 MG, Secukinumab 150 MG/ML Subcutaneous Solution [COSENTYX], standard therapy
Keywords
COVID 19, colchicine, ruxolitinib, secukinumab
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ColchicineDrug

    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 MGDrug

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

  • Secukinumab 150 MG/ML Subcutaneous Solution [COSENTYX]Drug

    Secukinumab - 300mg subcutaneously singly

  • standard therapyOther

    standard therapy for COVID 19

Study groups in NCT04403243
Study groupRoleWhat they receive
1. ColchicineExperimental30 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
Receives: Drug: Colchicine
2. RuxolitinibExperimental10 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
Receives: Drug: Ruxolitinib 5 MG
3.SecukinumabExperimental10 Patients with mild and severe COVID 19 Patients will get investigated therapy singly. Patients will be follow-up during 45 days after randomization
Receives: Drug: Secukinumab 150 MG/ML Subcutaneous Solution [COSENTYX]
4.Standard treatmentActive 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
Receives: Other: standard therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: baseline, day 12

Secondary outcomes (5)

  1. Combine endpoint: Time to death or mechanical ventilation

    time to death or mechanical ventilation

    Measured: 45 days

  2. C-reactive protein

    Change from baseline in C-reactive protein

    Measured: baseline, day 12, day 45

  3. D-dimer

    Change from baseline in D-dimer

    Measured: baseline, day 12, day 45

  4. 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.

    Measured: baseline, day 12, day 45

  5. exposure area on lung CT

    Change from baseline in exposure area on lung CT

    Measured: baseline, day 12, day 45

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 May 2020
  2. Study start8 May 2020
  3. Primary completion22 Jul 2020
  4. Study completion23 Aug 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Patients will be randomized 3:1:1:3 into four groups: colchicine, ruxolitinib, secukinumab, and control group
Masking
None (open label)
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04403243
Sponsor's protocol ID
MSU080520
Acronym
COLORIT
Status last verified
Nov 2022
First submitted
20 May 2020
Last updated
25 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • 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.

    PubMed 34658014

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Colchicine, Ruxolitinib 5 MG and Secukinumab 150 MG/ML Subcutaneous Solution [COSENTYX] in people with COVID 19, run by Lomonosov Moscow State University Medical Research and Educational Center at 1 site in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

change from baseline in clinical assessment score COVID 19 (CAS COVID 19) Frame: baseline (time frame: baseline, day 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04403243, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2022.

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