COVID-19ROCOVINCT05196477
Study of the Outcomes of Olokizumab Therapy in Hospitalized Patients With SARS-CoV-2 (COVID-19) Infection
An observational study of COVID-19, run by R-Pharm at 6 sites in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Olokizumab and Standard therapy
- Type of treatment
- Injection or infusion
- How many people
- 3,087 participants
- Where
- 6 sitesRussia
- Study dates
- 14 Jul 2021to 29 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
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- 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).
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Russia6 sites
State Budgetary Healthcare Institution "Regional Hospital № 3"
Chelyabinsk, 454021
Federal State Budgetary Educational Institution of Higher Education "Kazan State Medical University" under the Ministry of Health of the Russian Federation
Kazan', Tatarstan Republic, 420012
State Budgetary Healthcare Institution "City Clinical Hospital named after F.I. Inozemtsev of Moscow Healthcare Department"
Moscow, 105187
St. Petersburg State Budgetary Healthcare Institution "City Hospital No. 40 of the Kurortny District"
Saint Petersburg, 197706
State Budgetary Institution of Healthcare of Tver region "Regional clinical hospital"
Tver', 170036
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, 450008
About this study
Official title: 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.
Read the 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.
- Conditions
- COVID-19
- Being tested
- Olokizumab, Standard therapy
- Keywords
- SARS-CoV-2, 2019-nCoV, Severe acute respiratory syndrome coronavirus 2, coronavirus
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlokizumabDrug
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 therapyDrug
Standard treatment (excluding administration of olokizumab, other interleukin (IL) (interleukin-1 and interleukin-17) inhibitors and Janus-kinase inhibitors.
| Study group | Role | What they receive |
|---|---|---|
| Olokizumab treatment group | Subjects with the infection caused by SARS-CoV-2 who received olokizumab injection in addition to the standard therapy. Receives: Drug: Olokizumab; Drug: Standard therapy | |
| Standard treatment group | Subjects with the infection caused by SARS-CoV-2 who received the standard therapy without monoclonal antibodies (mAbs). Receives: Drug: Standard therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 21 days
Secondary outcomes (4)
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.
Measured: 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
Measured: 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).
Measured: up to day 21
Overall hospitalisation period
Overall hospitalisation period duration in each therapy group (in days)
Measured: from admission to discharge from hospital, up to 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start14 Jul 2021
- Primary completion29 Aug 2022
- Study completion29 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,087 participants (actual)
Sponsor and investigators
- Lead sponsor
- R-Pharm
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Almedis LLC, Data Management 365, ScienceFiles LLC
- Responsible party
- Sponsor
- Investigators
- Mikhail Samsonov, Study director, R-Pharm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05196477
- Sponsor's protocol ID
- CL04041090
- Acronym
- ROCOVI
- Status last verified
- Jan 2023
- First submitted
- 18 Jan 2022
- Last updated
- 20 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre Non-interventional Retrospective Cohort Study of the Outcomes of Olokizumab Therapy in Hospitalized Patients With SARS-CoV-2 (COVID-19) Infection
- ClinicalTrials.gov ID
- NCT05196477
- Acronym / sponsor ID
- ROCOVI / CL04041090
- Conditions
- COVID-19
- Keywords
- SARS-CoV-2, 2019-nCoV, Severe acute respiratory syndrome coronavirus 2, coronavirus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,087 participants (actual)
- Lead sponsor
- R-PharmIndustry (pharma, biotech, devices)
- Collaborators
- Almedis LLC, Data Management 365, ScienceFiles LLC
- Study start
- 14 Jul 2021 (actual)
- Primary completion
- 29 Aug 2022 (actual)
- Study completion
- 29 Aug 2022 (actual)
- First posted
- 19 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Olokizumab treatment group | – | Drug: Olokizumab, Drug: Standard therapySubjects with the infection caused by SARS-CoV-2 who received olokizumab injection in addition to the standard therapy. |
| Standard treatment group | – | Drug: Standard therapySubjects with the infection caused by SARS-CoV-2 who received the standard therapy without monoclonal antibodies (mAbs). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (11 listed)
- 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:
- Olokizumab therapy - for the test group.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OlokizumabThe 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 | Olokizumab treatment group |
| Standard therapyStandard treatment (excluding administration of olokizumab, other interleukin (IL) (interleukin-1 and interleukin-17) inhibitors and Janus-kinase inhibitors. | Drug | Olokizumab treatment group, Standard treatment group |
Primary outcome
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
4 secondary outcomes
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 transfer to ICU
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)
Time frame: up to day 21
Overall hospitalisation period
Time frame: from admission to discharge from hospital, up to 21 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mikhail Samsonov study director
R-Pharm
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by R-Pharm at 6 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of patients who died during hospital admission due to any reason (time frame: up to 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2023; AzTrials last refreshed its copy on 8 Nov 2026.