Tocilizumab in hospitalized patients with COVID‐19: Clinical outcomes, inflammatory marker kinetics, and safety

Hill, Joshua A.; Menon, Manoj; Dhanireddy, Shireesha; Wurfel, Mark M.; Green, Margaret; Jain, Rupali; Chan, Jeannie D.; Huang, Joanne; Bethune, Danika; Turtle, Cameron J.; Johnston, Christine; Xie, Hu; Leisenring, Wendy M.; Kim, H Nina; Cheng, Guang‐Shing

doi:10.1002/jmv.26674

Cited by 34 publications

(40 citation statements)

References 50 publications

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“…Our data contradict this assumption. Two recent analyses which included only studies with a comparator cohort support our conclusion [ 65 , 66 ]. Also, Mao and colleagues reported use of tocilizumab did not decrease risk of death possibly because of an increased risk of secondary bacterial infections [ 67 ].…”

Section: Discussionsupporting

confidence: 76%

Systematic review and meta-analysis of tocilizumab in persons with coronavirus disease-2019 (COVID-19)

Chen

Wei

et al. 2021

Leukemia

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We performed a meta-analysis to determine safety and efficacy of tocilizumab in persons with coronavirus disease-2019 (COVID-19). We searched PubMed, Web of Science and Medline using Boolean operators for studies with the terms coronavirus OR COVID-19 OR 2019-nCoV OR SARS-CoV-2 AND tocilizumab. Review Manager 5.4 was used to analyze data and the modified Newcastle–Ottawa and Jadad scales for quality assessment. We identified 32 studies in 11,487 subjects including three randomized trials and 29 cohort studies with a comparator cohort, including historical controls (N = 5), a matched cohort (N = 12), or concurrent controls (N = 12). Overall, tocilizumab decreased risk of death (Relative Risk [RR] = 0.74; 95% confidence interval [CI], 0.59, 0.93; P = 0.008; I2 = 80%) but not of surrogate endpoints including ICU admission (RR = 1.40 [0.64,3.06]; P = 0.4; I2 = 88%), invasive mechanical ventilation (RR = 0.83 [0.57,1.22]; P = 0.34; I2 = 65%) or secondary infections (RR = 1.30 [0.97,1.74]; P = 0.08; I2 = 65%) and increased interval of hospitalization of subjects discharged alive(mean difference [MD] = 2 days [<1, 4 days]; P = 0.006; I2 = 0). RRs of death in studies with historical controls (RR = 0.28 [0.16,0.49; P < 0.001]; I2 = 62%) or a matched cohort (RR = 0.68 [0.53, 0.87]; P = 0.002; I2 = 42%) were decreased. In contrast, RRs of death in studies with a concurrent control (RR = 1.10 [0.77, 1.56]; P = 0.60; I2 = 85%) or randomized (RR = 1.18 [0.57,2.44]; P = 0.66; I2 = 0) were not decreased. A reduced risk of death was not confirmed in our analyses which questions safety and efficacy of tocilizumab in persons with COVID-19.

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Section: Discussionsupporting

confidence: 76%

Systematic review and meta-analysis of tocilizumab in persons with coronavirus disease-2019 (COVID-19)

Chen

Wei

et al. 2021

Leukemia

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“…The relatively high occurrence of false-negative test results makes a new sampling device desirable. Other diagnostic tests include chest CT scans, on which ground-glass opacities appear as typical abnormalities for COVID-19, and analysis of for instance stools or saliva via RT-PCR for detection of current infection [ 17 , 18 ]. All these tests, however, are expensive and time consuming, require trained personnel, and, in the case of chest CT scans, expose patients to X-rays.…”

mentioning

confidence: 99%

Applying the electronic nose for pre-operative SARS-CoV-2 screening

et al. 2020

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Background Infection with SARS-CoV-2 causes corona virus disease (COVID-19). The most standard diagnostic method is reverse transcription-polymerase chain reaction (RT-PCR) on a nasopharyngeal and/or an oropharyngeal swab. The high occurrence of false-negative results due to the non-presence of SARS-CoV-2 in the oropharyngeal environment renders this sampling method not ideal. Therefore, a new sampling device is desirable. This proof-of-principle study investigated the possibility to train machine-learning classifiers with an electronic nose (Aeonose) to differentiate between COVID-19-positive and negative persons based on volatile organic compounds (VOCs) analysis. Methods Between April and June 2020, participants were invited for breath analysis when a swab for RT-PCR was collected. If the RT-PCR resulted negative, the presence of SARS-CoV-2-specific antibodies was checked to confirm the negative result. All participants breathed through the Aeonose for five minutes. This device contains metal-oxide sensors that change in conductivity upon reaction with VOCs in exhaled breath. These conductivity changes are input data for machine learning and used for pattern recognition. The result is a value between − 1 and + 1, indicating the infection probability. Results 219 participants were included, 57 of which COVID-19 positive. A sensitivity of 0.86 and a negative predictive value (NPV) of 0.92 were found. Adding clinical variables to machine-learning classifier via multivariate logistic regression analysis, the NPV improved to 0.96. Conclusions The Aeonose can distinguish COVID-19 positive from negative participants based on VOC patterns in exhaled breath with a high NPV. The Aeonose might be a promising, non-invasive, and low-cost triage tool for excluding SARS-CoV-2 infection in patients elected for surgery.

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Section: Discussionmentioning

confidence: 99%

“…Hypoalbuminemia occurs in about one-third of patients with COVID-19, particularly in those with severe disease [ 24 ]. Several studies have found a consistent association between low albumin level and an increase in both mortality and length of hospital stay [ 24 ]. A serum albumin level < 3.5 g/dL is an independent predictor of death and increases the OR for in-hospital mortality by up to six times [ 25 ].…”

Section: Discussionmentioning

confidence: 99%

“…Liver dysfunction may be secondary to angiotensin-converting enzyme 2 (ACE2)-mediated hepatitis, although a recent study detected active viremia in only 7% of patients, which means that liver dysfunction caused by ACE2-mediated hepatitis does not seem to account for the liver disorders commonly observed in patients with COVID-19 [ 28 ]. By contrast, a dysregulated immune response may be a crucial pathogenic contributor to liver disorders in the early stages of COVID-19, which could lead to increased capillary permeability and the release of albumin into the interstitial space [ 24 ]. A causative role of hyper-inflammation is supported by the extremely high levels of CRP, IL-6, and macrophage colony-stimulating factor found in patients with COVID-19 and liver injury and hypoalbuminemia [ 28 ].…”

Section: Discussionmentioning

confidence: 99%

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A simple and readily available inflammation-based risk scoring system on admission predicts the need for mechanical ventilation in patients with COVID-19

et al. 2021

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Objective To investigate whether a simplified inflammation-based risk scoring system comprising three readily available biomarkers (albumin, C-reactive protein, and leukocytes) may predict major adverse outcomes in patients with COVID-19. Methods Upon admission to the emergency room, the inflammation-based risk scoring system was applied and patients were classified as having mild, moderate, or severe inflammation. In-hospital occurrence of thrombosis, need for mechanical ventilation, and death were recorded. Results One-hundred patients (55 ± 13 years; 71% men) were included and classified as having mild (29%), moderate (12%), or severe (59%) inflammation. The need for mechanical ventilation differed among patients in each group (16%, 50%, and 71%, respectively; P < 0.0001), yielding a 4.1-fold increased risk of requiring mechanical ventilation in patients with moderate inflammation and 5.4 for those with severe inflammation. On the contrary, there were no differences for the occurrence of thrombosis (10%, 8%, and 22%, respectively; P = 0.142) or death (21%, 42%, and 39%, respectively; P = 0.106). In the multivariate analysis, only severe inflammation (hazard ratio [HR] = 4.1), D-dimer > 574 ng/mL (HR = 3.0), and troponin I ≥ 6.7 ng/mL (HR = 2.4) at hospital admission were independent predictors of the need for mechanical ventilation. Conclusion The inflammation-based risk scoring system predicts the need for mechanical ventilation in patients with severe COVID-19.

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Tocilizumab in hospitalized patients with COVID‐19: Clinical outcomes, inflammatory marker kinetics, and safety

Cited by 34 publications

References 50 publications

Systematic review and meta-analysis of tocilizumab in persons with coronavirus disease-2019 (COVID-19)

Systematic review and meta-analysis of tocilizumab in persons with coronavirus disease-2019 (COVID-19)

Applying the electronic nose for pre-operative SARS-CoV-2 screening

A simple and readily available inflammation-based risk scoring system on admission predicts the need for mechanical ventilation in patients with COVID-19

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