Tocilizumab, Netakimab, and Baricitinib Versus Standard of Care Therapy in Patients With Mild to Moderate COVID-19 - a Retrospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 154
- 试验地点
- 2
- 主要终点
- Changing in the level of C-reactive protein
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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/
- •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
排除标准
- •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.
研究组 & 干预措施
Baricitinib
group included patients received Baricitinib in addition to standard of care therapy
干预措施: Baricitinib Oral Tablet (Drug)
Tocilizumab
group included patients received Tocilizumab in addition to standard of care therapy
干预措施: Tocilizumab Injection (Drug)
Netakimab
group included patients received Netakimab in addition to standard of care therapy
干预措施: Netakimab (Drug)
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.
干预措施: Standard of care therapy (Other)
结局指标
主要结局
Changing in the level of C-reactive protein
时间窗: 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
次要结局
- Changing in the level of Lactate dehydrogenase(5 days)
- Assessment of the absolute lymphocyte count in dynamic(5 days)
- Changing of the National Early Warning Score2(5 days)
- Assessment of the absolute neutrophil count in dynamic(5 days)
- Assessment of the neutrophil-to-lymphocyte ratio(5 days)
研究者
Dmitry Chudakov
Professor Chudakov D.M., D.Sc., Director of Research Institute of Translational Medicine, Head of the Department of molecular technologies
Pirogov Russian National Research Medical University