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

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ClinicalTrials.gov Identifier: NCT05196477
Recruitment Status : Completed
First Posted : January 19, 2022
Last Update Posted : January 20, 2023
Sponsor:
Collaborators:
Almedis LLC
Data Management 365
ScienceFiles LLC
Information provided by (Responsible Party):
R-Pharm

Study Description
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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.

Condition or disease Intervention/treatment
COVID-19 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 Design
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Study Type : Observational
Actual Enrollment : 3087 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Multicentre Non-interventional Retrospective Cohort Study of the Outcomes of Olokizumab Therapy in Hospitalized Patients With SARS-CoV-2 (COVID-19) Infection
Actual Study Start Date : July 14, 2021
Actual Primary Completion Date : August 29, 2022
Actual Study Completion Date : August 29, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. The percentage of patients who died during hospital admission due to any reason [ Time Frame: up to 21 days ]
    The percentage of patients who died during hospital admission due to any reason in each therapy group


Secondary Outcome Measures :
  1. 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 [ Time Frame: up to day 21 ]
    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.

  2. The percentage of patients who required transfer to ICU [ Time Frame: up to day 21 ]
    The percentage of patients who required transfer to ICU in each therapy group

  3. The percentage of patients who required transfer to a new type of oxygen support and to an invasive mechanical ventilation (MV) [ Time Frame: up to day 21 ]
    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).

  4. Overall hospitalisation period [ Time Frame: from admission to discharge from hospital, up to 21 days ]
    Overall hospitalisation period duration in each therapy group (in days)


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05196477


Locations
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Russian Federation
Federal State Budgetary Educational Institution of Higher Education "Kazan State Medical University" under the Ministry of Health of the Russian Federation
Kazan, Tatarstan, Russian Federation, 420012
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, Russian Federation, 450008
State Budgetary Healthcare Institution "Regional Hospital № 3"
Chelyabinsk, Russian Federation, 454021
State Budgetary Healthcare Institution "City Clinical Hospital named after F.I. Inozemtsev of Moscow Healthcare Department"
Moscow, Russian Federation, 105187
St. Petersburg State Budgetary Healthcare Institution "City Hospital No. 40 of the Kurortny District"
Saint Petersburg, Russian Federation, 197706
State Budgetary Institution of Healthcare of Tver region "Regional clinical hospital"
Tver, Russian Federation, 170036
Sponsors and Collaborators
R-Pharm
Almedis LLC
Data Management 365
ScienceFiles LLC
Investigators
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Study Director: Mikhail Samsonov R-Pharm
More Information
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Responsible Party: R-Pharm
ClinicalTrials.gov Identifier: NCT05196477    
Other Study ID Numbers: CL04041090
First Posted: January 19, 2022    Key Record Dates
Last Update Posted: January 20, 2023
Last Verified: January 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by R-Pharm:
SARS-CoV-2
2019-nCoV
Severe acute respiratory syndrome coronavirus 2
coronavirus
Additional relevant MeSH terms:
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COVID-19
Infections
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases