Clinical trial

Multicentre Non-interventional Retrospective Cohort Study of the Outcomes of Olokizumab Therapy in Hospitalized Patients With SARS-CoV-2 (COVID-19) Infection

NCT05196477

Name

CL04041090

Description

The study purpose was to assess the outcomes of therapy with olokizumab within complex therapy of Coronavirus disease 2019 (COVID-19) in hospitalised patients in real clinical practice setting. The study investigated patients' characteristics, disease progression, and efficacy and safety of olokizumab therapy.

Trial arms

Trial start

2021-07-14

Estimated PCD

2022-08-29

Trial end

2022-08-29

Status

Completed

Treatment

Olokizumab

The details of taking olokizumab, including its route of administration, dose and frequency of taking the drug as part of routine clinical practice, will be registered in the electronic case report forms (eCRFs).

Arms:

Olokizumab treatment group

Standard therapy

Standard treatment (excluding administration of olokizumab, other interleukin (IL) (interleukin-1 and interleukin-17) inhibitors and Janus-kinase inhibitors.

Arms:

Olokizumab treatment group, Standard treatment group

Size

3087

Primary endpoint

The percentage of patients who died during hospital admission due to any reason

up to 21 days

Eligibility criteria

Inclusion Criteria: * Confirmed diagnosis of SARS-CoV-2 (using virus ribonucleic acid polymerase chain reaction (RNA PCR) test). * Hospital admission for COVID-19 therapy. * Infiltrative lung changes based on imaging findings (chest X-ray, chest computed tomography (CT)). * Indications for Preemptive anti-inflammatory therapy (PAT), including two or more signs below: * reduced oxygen saturation of the blood SpO2 ≤ 97 % * C-reactive protein (CRP) \> 15 mg/L * body temperature \> 37.5 °C for at least 3 days * white blood cell count \< 4.0 x 10\^9/L * absolute lymphocyte count \< 2.0 x 10\^9/L. * Olokizumab therapy - for the test group. * Source medical documents contain the information required for the study (lacking or incomplete data on some serum chemistry values are allowed: D-dimer, ferritin, IL-6, procalcitonin). Exclusion Criteria: * Inadequate information on patient's characteristics and therapy. * Lack of documented confirmation of SARS-CoV-2 infection. * Initiation of mechanical ventilation (MV) from the first day of admission in the control group or before olokizumab administration in the test group. * Administration of systemic corticosteroids, IL-6, other immunosuppressants or immunoglobulins before hospital admission. * Lack of indications to PAT * Administration of olokizumab, other interleukin (IL) (interleukin-1 and interleukin-17) inhibitors and Janus-kinase inhibitors - for comparator group.

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 3087, 'type': 'ACTUAL'}}

Updated at

2023-01-20

1 organization

2 products

1 indication

Organization

Product

Indication

Product