An observational study in COVID-19 and Mild to Moderate, sponsored by Pirogov Russian National Research Medical University. Completed at 2 sites in Russia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-08.
Sponsored by Pirogov Russian National Research Medical University · Observational
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.
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.
7,775 studies on the registry are indexed under COVID-19; 482 are open to participants now.
This study's enrollment of 154 is below the median of 260 across 3,188 observational studies indexed under COVID-19.
Browse COVID-19 studies →Pirogov Russian National Research Medical University is the lead sponsor of 57 studies on the registry; 15 are open to participants now.
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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.
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Subjects who meet all of the following criteria were included in the study:
Exclusion Criteria:
Subjects who meet any of the following criteria were excluded from participation in the study:
group included patients received Baricitinib in addition to standard of care therapy
Drug: Baricitinib Oral Tablet
group included patients received Tocilizumab in addition to standard of care therapy
Drug: Tocilizumab Injection
group included patients received Netakimab in addition to standard of care therapy
Drug: Netakimab
group included patients received only standard of care therapy at the time of hospital admission according to the corresponding COVID-19 Russian guidelines 2020.
Other: Standard of care therapy
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
Also known as: Olumiant
Tocilizumab was administered by a single intravenous dose of 400 mg
Also known as: Actemra
Netakimab was administered by a single subcutaneous injection of 120 mg
Also known as: Efleira
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
Also known as: SOC
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
Time frame: 5 days
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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 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.
Time frame: 5 days
Hospital discharge day and mortality data
The amount of days in the hospital after the start of therapy was estimated for each patients and and analysed as the following groups: less than 4 days in hospital; 5-7 days in hospital; 8-14 days in hospital; more than 15 days in hospital. Outcome (hospital discharge or death) was assessed on the last day of follow-up, the longest period of hospitalisation was 21 days.
Time frame: 21 days
Plan to share: No
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Ran from Feb 2020 to primary completion in Aug 2020, 6 months.
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This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Pirogov Russian National Research Medical University