An observational study in COVID-19, sponsored by R-Pharm. Completed at 6 sites in Russia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-01-20.
Sponsored by R-Pharm · Observational
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.
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.
7,774 studies on the registry are indexed under COVID-19; 482 are open to participants now.
This study's enrollment of 3,087 is above the median of 260 across 3,188 observational studies indexed under COVID-19.
Browse COVID-19 studies →R-Pharm is the lead sponsor of 58 studies on the registry; 2 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Indications for Preemptive anti-inflammatory therapy (PAT), including two or more signs below:
Exclusion Criteria:
Subjects with the infection caused by SARS-CoV-2 who received olokizumab injection in addition to the standard therapy.
Drug: Olokizumab · Drug: Standard therapy
Subjects with the infection caused by SARS-CoV-2 who received the standard therapy without monoclonal antibodies (mAbs).
Drug: Standard therapy
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).
Standard treatment (excluding administration of olokizumab, other interleukin (IL) (interleukin-1 and interleukin-17) inhibitors and Janus-kinase inhibitors.
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
Time frame: up to 21 days
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.
Time frame: 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
Time frame: 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).
Time frame: up to day 21
Overall hospitalisation period
Overall hospitalisation period duration in each therapy group (in days)
Time frame: from admission to discharge from hospital, up to 21 days
This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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