NCT05196477

Brief Summary

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 Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,087

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 14, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 18, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 19, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 29, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 29, 2022

Completed
Last Updated

January 20, 2023

Status Verified

January 1, 2023

Enrollment Period

1.1 years

First QC Date

January 18, 2022

Last Update Submit

January 18, 2023

Conditions

COVID-19

Keywords

SARS-CoV-22019-nCoVSevere acute respiratory syndrome coronavirus 2coronavirus

Outcome Measures

Primary Outcomes (1)

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

    The percentage of patients who died during hospital admission due to any reason in each therapy group

    up to 21 days

Secondary Outcomes (4)

  • The percentage of patients who required mechanical ventilation or transfer to intensive care unit (ICU), or who died during hospital admission due to COVID-19

    up to day 21

  • The percentage of patients who required transfer to ICU

    up to day 21

  • The percentage of patients who required transfer to a new type of oxygen support and to an invasive mechanical ventilation (MV)

    up to day 21

  • Overall hospitalisation period

    from admission to discharge from hospital, up to 21 days

Study Arms (2)

Olokizumab treatment group

Subjects with the infection caused by SARS-CoV-2 who received olokizumab injection in addition to the standard therapy.

Drug: OlokizumabDrug: Standard therapy

Standard treatment group

Subjects with the infection caused by SARS-CoV-2 who received the standard therapy without monoclonal antibodies (mAbs).

Drug: Standard therapy

Interventions

OlokizumabDRUG

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).

Olokizumab treatment group
Standard therapyDRUG

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

Olokizumab treatment groupStandard treatment group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study enrolls males and females aged ≥ 18 years with infection caused by SARS-CoV-2 who received in-hospital therapy. The study population includes all the patients admitted to hospital since June 2020, meeting inclusion / exclusion criteria with their data collected and analysed.

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Federal State Budgetary Educational Institution of Higher Education "Kazan State Medical University" under the Ministry of Health of the Russian Federation

Kazan', Tatarstan Republic, 420012, Russia

Location

Federal State Budgetary Educational Institution of Higher Education Bashkir State Medical University of the Ministry for Healthcare of the Russian Federation

Ufa, The Republic of Bashkortostan, 450008, Russia

Location

State Budgetary Healthcare Institution "Regional Hospital № 3"

Chelyabinsk, 454021, Russia

Location

State Budgetary Healthcare Institution "City Clinical Hospital named after F.I. Inozemtsev of Moscow Healthcare Department"

Moscow, 105187, Russia

Location

St. Petersburg State Budgetary Healthcare Institution "City Hospital No. 40 of the Kurortny District"

Saint Petersburg, 197706, Russia

Location

State Budgetary Institution of Healthcare of Tver region "Regional clinical hospital"

Tver', 170036, Russia

Location

MeSH Terms

Conditions

COVID-19Coronavirus Infections

Interventions

olokizumabStandard of Care

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Mikhail Samsonov

    R-Pharm

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2022

First Posted

January 19, 2022

Study Start

July 14, 2021

Primary Completion

August 29, 2022

Study Completion

August 29, 2022

Last Updated

January 20, 2023

Record last verified: 2023-01

Locations

RU(6)