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

Sponsor
Lomonosov Moscow State University Medical Research and Educational Center
Study ID
NCT04403243
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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

Key Dates

Start date
May 8, 2020
Status verified
Nov 2022
Primary completion
Jul 22, 2020
Completion
Aug 23, 2020

Study Design

Enrollment
70 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 1. 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
  • Experimental: 2. Ruxolitinib
    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
  • Experimental: 3.Secukinumab
    10 Patients with mild and severe COVID 19 Patients will get investigated therapy singly. Patients will be follow-up during 45 days after randomization
  • Active Comparator: 4.Standard treatment
    -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

Primary Outcome Measure

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

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