COVID-19 Clinical Trial
— ROCOVIOfficial title:
Multicentre Non-interventional Retrospective Cohort Study of the Outcomes of Olokizumab Therapy in Hospitalized Patients With SARS-CoV-2 (COVID-19) Infection
NCT number | NCT05196477 |
Other study ID # | CL04041090 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | July 14, 2021 |
Est. completion date | August 29, 2022 |
Verified date | January 2023 |
Source | R-Pharm |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | 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.
Status | Completed |
Enrollment | 3087 |
Est. completion date | August 29, 2022 |
Est. primary completion date | August 29, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Russian Federation | State Budgetary Healthcare Institution "Regional Hospital ? 3" | Chelyabinsk | |
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 | State Budgetary Healthcare Institution "City Clinical Hospital named after F.I. Inozemtsev of Moscow Healthcare Department" | Moscow | |
Russian Federation | St. Petersburg State Budgetary Healthcare Institution "City Hospital No. 40 of the Kurortny District" | Saint Petersburg | |
Russian Federation | State Budgetary Institution of Healthcare of Tver region "Regional clinical hospital" | Tver | |
Russian Federation | 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 |
Lead Sponsor | Collaborator |
---|---|
R-Pharm | Almedis LLC, Data Management 365, ScienceFiles LLC |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Overall hospitalisation period | Overall hospitalisation period duration in each therapy group (in days) | from admission to discharge from hospital, up to 21 days |
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