Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1. Colchicine | Experimental | 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 |
|
| 2. Ruxolitinib | Experimental | 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 |
|
| 3.Secukinumab | Experimental | 10 Patients with mild and severe COVID 19 Patients will get investigated therapy singly. Patients will be follow-up during 45 days after randomization |
|
| 4.Standard treatment | Active 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
Minimal number of points - 0; max - 20. Lower the score-better health | baseline, day 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Combine endpoint: Time to death or mechanical ventilation | time to death or mechanical ventilation | 45 days |
| C-reactive protein | Change from baseline in C-reactive protein |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lomonosov Moscow State University Medical Research and Educational Center | Moscow | Moscow Oblast | 119620 | Russia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34658014 | Derived | 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. |
Not provided
Not provided
Not provided
4 month
Medical professionals By the request
Not provided
Not provided
Patients will be randomized 3:1:1:3 into four groups: colchicine, ruxolitinib, secukinumab, and control group
Not provided
Not provided
Not provided
Not provided
| 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 |
|
| baseline, day 12, day 45 |
| D-dimer | Change from baseline in D-dimer | baseline, day 12, day 45 |
| 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 |
| exposure area on lung CT | Change from baseline in exposure area on lung CT | baseline, day 12, day 45 |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D003078 | Colchicine |
| C540383 | ruxolitinib |
| C555450 | secukinumab |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
Not provided
Not provided