Abstract:Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre-including this research content-immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with r… Show more
“… 153 Moreno et al (2020) also found that TCZ decreased mortality and duration of hospital stay in critically ill patients but seemed to have a high risk of serious infections. 154 Similar outcomes were reported in another related study involving 158 COVID-19 patients. 155 Somers et al (2020) also found that tocilizumab significantly decreased mortality among 154 patients with severe COVID-19.…”
Section: Resultssupporting
confidence: 81%
“… 165–170 In addition to a lack of effectiveness with TCZ, Moreno Perez et al (2020) also found that critically ill patients taking TCZ appeared to have a high risk of severe infections. 154 Consequently, despite the promise shown by tocilizumab in relieving inflammation, decreased mortality, and duration of hospital stay in some studies, we believe more research is needed before the place of TCZ in the treatment of patients with COVID-19 can be fully elucidated. 163 …”
“… 153 Moreno et al (2020) also found that TCZ decreased mortality and duration of hospital stay in critically ill patients but seemed to have a high risk of serious infections. 154 Similar outcomes were reported in another related study involving 158 COVID-19 patients. 155 Somers et al (2020) also found that tocilizumab significantly decreased mortality among 154 patients with severe COVID-19.…”
Section: Resultssupporting
confidence: 81%
“… 165–170 In addition to a lack of effectiveness with TCZ, Moreno Perez et al (2020) also found that critically ill patients taking TCZ appeared to have a high risk of severe infections. 154 Consequently, despite the promise shown by tocilizumab in relieving inflammation, decreased mortality, and duration of hospital stay in some studies, we believe more research is needed before the place of TCZ in the treatment of patients with COVID-19 can be fully elucidated. 163 …”
“…Non-randomised studies have suggested that tocilizumab might have a role in controlling cytokine release syndrome associated with covid-19. 26 27 28 29 30 31 32 33 34 Most observational studies, although not all, suggest a benefit of tocilizumab on clinical outcomes. 26 30 31 33 Results from observational studies are, however, limited owing to a high risk of confounding.…”
Objective
To determine whether tocilizumab improves clinical outcomes for patients with severe or critical coronavirus disease 2019 (covid-19).
Design
Randomised, open label trial.
Setting
Nine hospitals in Brazil, 8 May to 17 July 2020.
Participants
Adults with confirmed covid-19 who were receiving supplemental oxygen or mechanical ventilation and had abnormal levels of at least two serum biomarkers (C reactive protein, D dimer, lactate dehydrogenase, or ferritin). The data monitoring committee recommended stopping the trial early, after 129 patients had been enrolled, because of an increased number of deaths at 15 days in the tocilizumab group.
Interventions
Tocilizumab (single intravenous infusion of 8 mg/kg) plus standard care (n=65) versus standard care alone (n=64).
Main outcome measure
The primary outcome, clinical status measured at 15 days using a seven level ordinal scale, was analysed as a composite of death or mechanical ventilation because the assumption of odds proportionality was not met.
Results
A total of 129 patients were enrolled (mean age 57 (SD 14) years; 68% men) and all completed follow-up. All patients in the tocilizumab group and two in the standard care group received tocilizumab. 18 of 65 (28%) patients in the tocilizumab group and 13 of 64 (20%) in the standard care group were receiving mechanical ventilation or died at day 15 (odds ratio 1.54, 95% confidence interval 0.66 to 3.66; P=0.32). Death at 15 days occurred in 11 (17%) patients in the tocilizumab group compared with 2 (3%) in the standard care group (odds ratio 6.42, 95% confidence interval 1.59 to 43.2). Adverse events were reported in 29 of 67 (43%) patients who received tocilizumab and 21 of 62 (34%) who did not receive tocilizumab.
Conclusions
In patients with severe or critical covid-19, tocilizumab plus standard care was not superior to standard care alone in improving clinical outcomes at 15 days, and it might increase mortality.
Trial registration
ClinicalTrials.gov
NCT04403685
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“…Intense exercise also produces large quantities of IL-6 [23] , which may account for the more severe clinical manifestations of infection amongst athletes [24] . Indeed, dexamethasone, which lowers production of IL-6 by human bronchial epithelium [25] , has recently been successfully trialled in COVID-19 patients [26] , and there is increasing evidence that tocilizumab, an IL-6 antagonist, can result in improved outcomes amongst severely affected patients [27] . Fig.…”
Highlights
Interleukin IL-6 facilitates COVID-19 viral cell entry and replication.
Healthy IL-6 levels correlate with COVID-19 morbidity in similar matched populations.
Vitamin D administration appears to lower IL-6 levels in humans.
IL-6 modulation with Vitamin D and other means may be a useful therapeutic strategy in COVID-19.
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