Study of the Outcomes of Olokizumab Therapy in Hospitalized Patients With SARS-CoV-2 (COVID-19) Infection (ROCOVI)

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

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.

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Drug: Olokizumab; Drug: Standard therapy

Detailed Description

This was a multicentre retrospective cohort study of patients admitted to hospitals in various Russian Federation cities with positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) nucleic acid (RNA) laboratory test for the treatment of severe acute respiratory syndrome. The study used information from primary medical documentation of COVID-19 patients who had underwent diagnostic and therapeutic procedures in accordance with the hospital clinical practice. Clinical and laboratory data was collected and analysed to assess olokizumab safety, investigate other treatments, course and outcomes of the disease.

No additional tests or medical procedures were made as part of this study. If any data collected under the protocol was not available or not collected, they deemed lacking.

Based on the results of preliminary assessment of the number of records from the patients meeting inclusion / exclusion criteria in the clinical sites planning to participate in the project it was planned to include no more than 3000 patients in the study, of which about 1500 would be in the main group (received olokizumab therapy), and 1500 would be in the comparison group. It was planned to conduct an analysis in the general population (including taking into account its balancing using statistical methods, in case of significant differences in the initial characteristics of patients in groups), as well as in a subpopulation selected from pairs formed taking into account the comparability of patients by individual characteristics. In total, it was planned to form at least 200 pairs (or more, if the included population is highly comparable). Participation of several clinics in Russian Federation cities (not more than 10 cites) was expected to assure sufficient population for the study.

Data collection period for each hospitalised patient was equivalent to in-hospital period for the treatment of SARS-CoV-2 infection. Data collection by patients was made during hospital stay, including the day of discharge (treatment outcome or lethal outcome). The primary study variables were defined during 21-day observation period.

• Study Type: Observational
• Enrollment (Actual): 3087

Contacts and Locations

Study Locations

• Russian Federation
  • Chelyabinsk, Russian Federation, 454021
    • State Budgetary Healthcare Institution "Regional Hospital № 3"
  • Moscow, Russian Federation, 105187
    • State Budgetary Healthcare Institution "City Clinical Hospital named after F.I. Inozemtsev of Moscow Healthcare Department"
  • Saint Petersburg, Russian Federation, 197706
    • St. Petersburg State Budgetary Healthcare Institution "City Hospital No. 40 of the Kurortny District"
  • Tver, Russian Federation, 170036
    • State Budgetary Institution of Healthcare of Tver region "Regional clinical hospital"
  • Tatarstan
    • Kazan, Tatarstan, Russian Federation, 420012
      • Federal State Budgetary Educational Institution of Higher Education "Kazan State Medical University" under the Ministry of Health of the Russian Federation
  • The Republic Of Bashkortostan
    • Ufa, The Republic Of Bashkortostan, Russian Federation, 450008
      • Federal State Budgetary Educational Institution of Higher Education Bashkir State Medical University of the Ministry for Healthcare of the Russian Federation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Olokizumab treatment group; Subjects with the infection caused by SARS-CoV-2 who received olokizumab injection in addition to the standard therapy.	Drug: 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).; Drug: Standard therapy; Standard treatment (excluding administration of olokizumab, other interleukin (IL) (interleukin-1 and interleukin-17) inhibitors and Janus-kinase inhibitors.
Standard treatment group; Subjects with the infection caused by SARS-CoV-2 who received the standard therapy without monoclonal antibodies (mAbs).	Drug: Standard therapy; Standard treatment (excluding administration of olokizumab, other interleukin (IL) (interleukin-1 and interleukin-17) inhibitors and Janus-kinase inhibitors.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	The percentage of patients who required mechanical ventilation or transfer to ICU, or who died after olokizumab therapy during hospital admission due to COVID-19.	up to day 21
The percentage of patients who required transfer to ICU	The percentage of patients who required transfer to ICU in each therapy group	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)	The transfer to a new type of oxygen support means the transfer to a more severe type of oxygen support (the appointment of low-current oxygen to patients who were initially without oxygen support; transfer from low-flow oxygen therapy to high-flow, non-invasive or invasive ventilation; from high-flow oxygen therapy to non-invasive or invasive ventilation; from non-invasive to invasive ventilation).	up to day 21
Overall hospitalisation period	Overall hospitalisation period duration in each therapy group (in days)	from admission to discharge from hospital, up to 21 days

Collaborators and Investigators

• Sponsor: R-Pharm
• Collaborators: Data Management 365; Almedis LLC; ScienceFiles LLC

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2021
• Primary Completion (Actual): August 29, 2022
• Study Completion (Actual): August 29, 2022

Study Registration Dates

• First Submitted: January 18, 2022
• First Submitted That Met QC Criteria: January 18, 2022
• First Posted (Actual): January 19, 2022

Study Record Updates

• Last Update Posted (Actual): January 20, 2023
• Last Update Submitted That Met QC Criteria: January 18, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: SARS-CoV-2; coronavirus; 2019-nCoV; Severe acute respiratory syndrome coronavirus 2
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: CL04041090

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No