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Study of Efficacy of Different Treatment Regimens of Olokizumab

NCT05187793 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 198

Last updated 2023-02-13

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Olokizumab

Olokizumab, 128 mg, solution for subcutaneous administration 160 mg/mL

DRUG

Standard therapy

Standard treatment including: * Baricitinib, 4 mg, film coated tablets * Favipiravir, 200 mg, film coated tablets * Dexamethasone IV or IM OR Methylprednisolone IV

Sponsors & Collaborators

  • Federal Budget Institution of Science "Central Research Institute of Epidemiology" of the Rospotrebnadzor

    collaborator UNKNOWN

  • Group of companies Medsi, JSС

    collaborator UNKNOWN

  • R-Pharm

    lead INDUSTRY

Principal Investigators

  • Mikhail Samsonov · R-Pharm

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-08
Primary Completion
2022-10-31
Completion
2023-04-30

Countries

  • Russia

Study Locations

More Related Trials

Entities

Diseases

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 NCT05187793 on ClinicalTrials.gov