NCT04403243

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Lomonosov Moscow State University Medical Research and Educational Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2020-05-08
• Primary completion: 2020-07-22
• Completion: 2020-08-23
• First posted: 2020-05-27
• Last updated: 2022-11-25

Locations

1 site across 1 country: Russia