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drugset / Trial / NCT05187793

Study of Efficacy of Different Treatment Regimens of Olokizumab

NCT05187793 ↗

Phase 3 Unknown 198 enrolled R-Pharm Federal Budget Institution of Science "Central Research Institute of Epidemiology" of the Rospotrebnadzor · collabGroup of companies Medsi, JSС · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

The primary objective of the study is to evaluate the efficacy and safety of Artlegia (INN: olokizumab) new dosing regimen in patients with moderate coronavirus infection (COVID-19) with signs of hyperinflammation. This study is a multicentre, open-label, randomized, comparative, parallel group, active-controlled clinical trial.

Timeline

Start
2021-07-08
Primary completion
2022-10-31
Completion
2023-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Olokizumab Monoclonal antibody 128 mg Intravenous
Background Baricitinib Small molecule 4 mg Oral
Background Dexamethasone Small molecule 4 mg Intravenous
Background Dexamethasone Small molecule 20 mg Intravenous
Background Favipiravir Small molecule 600 mg Oral
Background Favipiravir Small molecule 800 mg Oral
Background Methylprednisolone Other / unclassified 1 mg/kg Intravenous

Indications

COVID-19