Status:
COMPLETED
Study of the Outcomes of Olokizumab Therapy in Hospitalized Patients With SARS-CoV-2 (COVID-19) Infection
Lead Sponsor:
R-Pharm
Collaborating Sponsors:
Almedis LLC
Data Management 365
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
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 st...
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) nucl...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 14 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 29 2022
Estimated Enrollment :
3087 Patients enrolled
Trial Details
Trial ID
NCT05196477
Start Date
July 14 2021
End Date
August 29 2022
Last Update
January 20 2023
Active Locations (6)
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1
Federal State Budgetary Educational Institution of Higher Education "Kazan State Medical University" under the Ministry of Health of the Russian Federation
Kazan', Tatarstan Republic, Russia, 420012
2
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, Russia, 450008
3
State Budgetary Healthcare Institution "Regional Hospital № 3"
Chelyabinsk, Russia, 454021
4
State Budgetary Healthcare Institution "City Clinical Hospital named after F.I. Inozemtsev of Moscow Healthcare Department"
Moscow, Russia, 105187