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

NCT04403243 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2022-11-25

No results posted yet for this study

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

Conditions

  • COVID 19

Interventions

DRUG

Colchicine

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.

DRUG

Ruxolitinib 5 MG

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

DRUG

Secukinumab 150 MG/ML Subcutaneous Solution [COSENTYX]

Secukinumab - 300mg subcutaneously singly

OTHER

standard therapy

standard therapy for COVID 19

Sponsors & Collaborators

  • Lomonosov Moscow State University Medical Research and Educational Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-08
Primary Completion
2020-07-22
Completion
2020-08-23

Countries

  • Russia

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04403243 on ClinicalTrials.gov