COVID-19NCT05302947
COVID-19 Study at the Russian Clinical and Research Center of Gerontology of the Pirogov RNRMU
An observational study of COVID-19 and Mild to Moderate, run by Pirogov Russian National Research Medical University at 2 sites in Russia.
Trial summary
This is a retrospective observational cohort study. About 1000 hospital charts of adult patients admitted to the hospital with mild-to-moderate COVID-19 from February to August 2020 were analyzed to evaluate the inflammatory markers and clinical outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Mild to Moderate
- What is being tested?
- Baricitinib Oral Tablet, Tocilizumab Injection and Netakimab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 154 participants
- Where
- 2 sitesRussia
- Study dates
- 1 Feb 2020to 30 Jun 2021
- 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: Patients with confirmed COVID-19, hospitalized into the Russian Clinical and Research Center of Gerontology of the Pirogov RNRMU or the City Clinical Hospital No. 52 of the Department of Health of the City of Moscow from 02/01/2020 to 08/31/2020.
Who may be able to join
- Subjects who meet all of the following criteria were included in the study:
- Patients were hospitalized in two Moscow specialized COVID-19 care units from 02/01/2020 to 08/31/2020.
- Patients had symptoms of acute respiratory infection (fever, muscle pain, cough) and radiologically-defined viral pneumonia as assessed by computed tomography
- All patients written informed consent for 'off-label' drug use for persons who received tocilizumab, netakimab, or baricitinib
Who cannot join
- Subjects who meet any of the following criteria were excluded from participation in the study:
- Pregnant women
- Patients with unknown National Early Warning Score 2 (NEWS2) metric or with NEWS2 > 6 points on the first day of therapy
- Patients with the plasma level of CRP > 140 mg/l on the first day of therapy
- Information about the outcome of patients (death or discharge from the hospital) was absent
- Patients who first time got the investigational drug later than 72 hours after hospitalization
- Patients who received a combination of the investigational drugs or application was differed to study design
- Patients with severe hematological, renal, or liver function impairment or evidence of concomitant bacterial infections.
Trial locations and contacts
2 sites in 1 country.
Russia2 sites
City Clinical Hospital No. 52 of the Department of Health of the City of Moscow
Moscow, 123182
Pirogov Russian National Research Medical University
Moscow
About this study
Official title: Tocilizumab, Netakimab, and Baricitinib Versus Standard of Care Therapy in Patients With Mild to Moderate COVID-19 - a Retrospective Observational Study
This is a retrospective observational cohort study. About 1000 hospital charts of adult patients admitted to the hospital with mild-to-moderate COVID-19 from February to August 2020 were analyzed to evaluate the inflammatory markers and clinical outcomes.
The aim of this study was to compare the observed results of targeted immunosuppressive therapy, anti-IL-6R (Tocilizumab), anti-IL-17A (Netakimab), and JAK1/JAK2 inhibitor (Baricitinib), with standard-of-care (SOC) therapy. The investigators hypothesize that, as compared to SOC therapy, all target drugs will demonstrate at least similar beneficial effects.
This observation may additionally support a rational choice for mild-to-moderate COVID-19 treatment strategy, considering the general safety profile and patient-specific limitations.
Read the detailed description
The clinical data from 154 patients were retrospectively collected according to Inclusion and Exclusion criteria. Finally all patients were divided into four groups depending on therapy: 38 patients who received Baricitinib and SOC; 34 patients who received Tocilizumab and SOC; 48 patients who received Netakimab and SOC and 34 patients who received only SOC.
For all patients the investigators assessed the National Early Warning Score2 (NEWS2), absolute neutrophil count (ANC), absolute lymphocyte count (ALC) and blood neutrophil-to-lymphocyte ratio (NLR) at baseline (0 h, the day of therapy started) and after 72 hours (3 days) and 120 hours (5 days) of therapy. The individual dynamics of c-reactive protein (CRP) and lactate dehydrogenase (LDH) were assessed for patients with known parameters at baseline and 72 h (Δ0-72) or at baseline and 120 h (Δ0-120) to avoid excluding from the analysis patients who lacked CRP or LDH data at one of the time points. The individual dynamics of CRP and LDH for patients for whom the results of sequential measurements were available for all three time points was also assessed separately.
Additionally, the clinical outcomes (death or hospital discharge) and amount of days in hospital after starting therapy were estimate for all 154 patients.
- Conditions
- COVID-19, Mild to Moderate
- Being tested
- Baricitinib Oral Tablet, Tocilizumab Injection, Netakimab, Standard of care therapy
- Keywords
- tocilizumab, baricitinib, netakimab, anti-IL-17, c-reactive protein, lactic dehydrogenase, neutrophil-to-lymphocyte ratio
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baricitinib Oral TabletDrug
Also called Olumiant
Baricitinib was administered at a dose of 4 mg once or twice per day for 3-8 days (5 days on average) depending on the individual patients' condition
Tocilizumab InjectionDrug
Also called Actemra
Tocilizumab was administered by a single intravenous dose of 400 mg
NetakimabDrug
Also called Efleira
Netakimab was administered by a single subcutaneous injection of 120 mg
Standard of care therapyOther
Also called SOC
SOC treatment included hydroxychloroquine (400 mg twice on day 1, followed by 200 mg twice per day on days 5-10), azithromycin (500 mg once per day for 5 days), lopinavir-ritonavir (400/100 mg twice per day for 14 days), and low molecular-weight heparin according to personal indicators
| Study group | Role | What they receive |
|---|---|---|
| Baricitinib | group included patients received Baricitinib in addition to standard of care therapy Receives: Drug: Baricitinib Oral Tablet | |
| Tocilizumab | group included patients received Tocilizumab in addition to standard of care therapy Receives: Drug: Tocilizumab Injection | |
| Netakimab | group included patients received Netakimab in addition to standard of care therapy Receives: Drug: Netakimab | |
| Control | group included patients received only standard of care therapy at the time of hospital admission according to the corresponding COVID-19 Russian guidelines 2020. Receives: Other: Standard of care therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changing in the level of C-reactive protein
The level of C-reactive protein (mg/L ) was measured by ELISA on the day of the start of therapy and then after 72 hours and 120 hours
Measured: 5 days
Secondary outcomes (5)
Changing in the level of Lactate dehydrogenase
The blood level of lactate dehydrogenase (LDH, U/L) was estimate by enzymatic UV-Kinetic method on the day of the start of therapy and then after 72 hours and 120 hours.
Measured: 5 days
Assessment of the absolute lymphocyte count in dynamic
The absolute lymphocyte count (ALC) was assessed by using an automatic hematology analyzer on the day of the start of therapy and then after 72 hours and 120 hours.
Measured: 5 days
Assessment of the absolute neutrophil count in dynamic
The absolute neutrophil count (ANC) was assessed by using an automatic hematology analyzer on the day of the start of therapy and then after 72 hours and 120 hours.
Measured: 5 days
Assessment of the neutrophil-to-lymphocyte ratio
The mathematical ratio of ANC to ALC were calculated for timepoints 0 ( the day of the start of therapy), 3 (72 hours after the start of the therapy) and 5 (120 hours after the start of the therapy)
Measured: 5 days
Changing of the National Early Warning Score2
The National Early Warning Score2 (NEWS2) metric based on physiological variables including blood pressure, heart rate, respiratory rate, temperature, oxygen saturation, and level of consciousness and falls on a scale of 0 to 20. NEWS2 value at 0-4 points corresponds to low clinical risk, 5-6 points to medium risk and 7 or more points to high clinical risk. NEWS2 was estimate on the day of the start of therapy and then after 72 hours and 120 hours.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start1 Feb 2020
- Primary completion31 Aug 2020
- Study completion30 Jun 2021
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
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pirogov Russian National Research Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- City Clinical Hospital No.52 of Moscow Healthcare Department
- Responsible party
- Principal investigator, Dmitry Chudakov, Pirogov Russian National Research Medical University
- Investigators
- Zinaida Yu Mutovina, MD-PhD, Principal investigator, City Clinical Hospital No.52 of Moscow Healthcare Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05302947
- Sponsor's protocol ID
- BaToNe-COV-2
- Other IDs
- 075-15-2020-807
- Status last verified
- Mar 2022
- First submitted
- 29 Mar 2022
- Last updated
- 8 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tocilizumab, Netakimab, and Baricitinib Versus Standard of Care Therapy in Patients With Mild to Moderate COVID-19 - a Retrospective Observational Study
- ClinicalTrials.gov ID
- NCT05302947
- Acronym / sponsor ID
- BaToNe-COV-2
- Conditions
- COVID-19, Mild to Moderate
- Keywords
- tocilizumab, baricitinib, netakimab, anti-IL-17, c-reactive protein, lactic dehydrogenase, neutrophil-to-lymphocyte ratio
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Pirogov Russian National Research Medical UniversityUniversity, hospital or other
- Collaborators
- City Clinical Hospital No.52 of Moscow Healthcare Department
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 31 Mar 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.
This is a retrospective observational cohort study. About 1000 hospital charts of adult patients admitted to the hospital with mild-to-moderate COVID-19 from February to August 2020 were analyzed to evaluate the inflammatory markers and clinical outcomes.
The aim of this study was to compare the observed results of targeted immunosuppressive therapy, anti-IL-6R (Tocilizumab), anti-IL-17A (Netakimab), and JAK1/JAK2 inhibitor (Baricitinib), with standard-of-care (SOC) therapy. The investigators hypothesize that, as compared to SOC therapy, all target drugs will demonstrate at least similar beneficial effects.
This observation may additionally support a rational choice for mild-to-moderate COVID-19 treatment strategy, considering the general safety profile and patient-specific limitations.
Detailed description
The clinical data from 154 patients were retrospectively collected according to Inclusion and Exclusion criteria. Finally all patients were divided into four groups depending on therapy: 38 patients who received Baricitinib and SOC; 34 patients who received Tocilizumab and SOC; 48 patients who received Netakimab and SOC and 34 patients who received only SOC.
For all patients the investigators assessed the National Early Warning Score2 (NEWS2), absolute neutrophil count (ANC), absolute lymphocyte count (ALC) and blood neutrophil-to-lymphocyte ratio (NLR) at baseline (0 h, the day of therapy started) and after 72 hours (3 days) and 120 hours (5 days) of therapy. The individual dynamics of c-reactive protein (CRP) and lactate dehydrogenase (LDH) were assessed for patients with known parameters at baseline and 72 h (Δ0-72) or at baseline and 120 h (Δ0-120) to avoid excluding from the analysis patients who lacked CRP or LDH data at one of the time points. The individual dynamics of CRP and LDH for patients for whom the results of sequential measurements were available for all three time points was also assessed separately.
Additionally, the clinical outcomes (death or hospital discharge) and amount of days in hospital after starting therapy were estimate for all 154 patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Baricitinib | – | Drug: Baricitinib Oral Tabletgroup included patients received Baricitinib in addition to standard of care therapy |
| Tocilizumab | – | Drug: Tocilizumab Injectiongroup included patients received Tocilizumab in addition to standard of care therapy |
| Netakimab | – | Drug: Netakimabgroup included patients received Netakimab in addition to standard of care therapy |
| Control | – | Other: Standard of care therapygroup included patients received only standard of care therapy at the time of hospital admission according to the corresponding COVID-19 Russian guidelines 2020. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with confirmed COVID-19, hospitalized into the Russian Clinical and Research Center of Gerontology of the Pirogov RNRMU or the City Clinical Hospital No. 52 of the Department of Health of the City of Moscow from 02/01/2020 to 08/31/2020.
Key inclusion criteria (4 listed)
- Patients were hospitalized in two Moscow specialized COVID-19 care units from 02/01/2020 to 08/31/2020.
- Patients had symptoms of acute respiratory infection (fever, muscle pain, cough) and radiologically-defined viral pneumonia as assessed by computed tomography
- All patients written informed consent for 'off-label' drug use for persons who received tocilizumab, netakimab, or baricitinib
Key exclusion criteria (8 listed)
- Subjects who meet any of the following criteria were excluded from participation in the study:
- Pregnant women
- Patients with unknown National Early Warning Score 2 (NEWS2) metric or with NEWS2 > 6 points on the first day of therapy
- Patients with the plasma level of CRP > 140 mg/l on the first day of therapy
- Information about the outcome of patients (death or discharge from the hospital) was absent
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 |
|---|---|---|
| Baricitinib Oral TabletAlso: OlumiantBaricitinib was administered at a dose of 4 mg once or twice per day for 3-8 days (5 days on average) depending on the individual patients' condition | Drug | Baricitinib |
| Tocilizumab InjectionAlso: ActemraTocilizumab was administered by a single intravenous dose of 400 mg | Drug | Tocilizumab |
| NetakimabAlso: EfleiraNetakimab was administered by a single subcutaneous injection of 120 mg | Drug | Netakimab |
| Standard of care therapyAlso: SOCSOC treatment included hydroxychloroquine (400 mg twice on day 1, followed by 200 mg twice per day on days 5-10), azithromycin (500 mg once per day for 5 days), lopinavir-ritonavir (400/100 mg twice per day for 14 days), and low molecular-weight heparin according to personal indicators | Other | Control |
Primary outcome
Changing in the level of C-reactive protein
Time frame: 5 days
The level of C-reactive protein (mg/L ) was measured by ELISA on the day of the start of therapy and then after 72 hours and 120 hours
5 secondary outcomes
Changing in the level of Lactate dehydrogenase
Time frame: 5 days
Assessment of the absolute lymphocyte count in dynamic
Time frame: 5 days
Assessment of the absolute neutrophil count in dynamic
Time frame: 5 days
Assessment of the neutrophil-to-lymphocyte ratio
Time frame: 5 days
Changing of the National Early Warning Score2
Time frame: 5 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 8 Apr 2022.
- Individual participant dataSharing planned: No
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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.
Zinaida Yu Mutovina, MD-PhD principal investigator
City Clinical Hospital No.52 of Moscow Healthcare Department
2 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 and Mild to Moderate, run by Pirogov Russian National Research Medical University at 2 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 4 inclusion and 8 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 8 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Changing in the level of C-reactive protein (time frame: 5 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 8 Apr 2022.