Tocilizumab as a Therapeutic Agent for Critically Ill Patients Infected with SARS‐CoV‐2
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Abstract
Tocilizumab is an IL‐6 receptor antagonist with the ability to suppress the cytokine storm in critically ill patients infected with severe acute respiratory syndrome‐coronavirus 2 (SARS‐CoV‐2). We evaluated patients treated with tocilizumab for a SARS‐CoV‐2 infection who were admitted between March 13, 2020, and April 16, 2020. This was a multicenter study with data collected by chart review both retrospectively and concurrently. Parameters evaluated included age, sex, race, use of mechanical ventilation (MV), usage of steroids and vasopressors, inflammatory markers, and comorbidities. Early dosing was defined as a tocilizumab dose administered prior to or within 1 day of intubation. Late dosing was defined as a dose administered > 1 day after intubation. In the absence of MV, the timing of the dose was related to the patient’s date of admission only. We evaluated 145 patients. The average age was 58.1 years, 64% were men, 68.3% had comorbidities, and 60% received steroid therapy. Disposition of patients was 48.3% discharged and 29.3% died, of which 43.9% were African American. MV was required in 55.9%, of which 34.5% died. Avoidance of MV ( P = 0.002) and increased survival ( P < 0.001) was statistically associated with early dosing. Tocilizumab therapy was effective at decreasing mortality and should be instituted early in the management of critically ill patients with coronavirus disease 2019) COVID‐19).
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SciScore for 10.1101/2020.06.05.20122622: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement Consent: Informed consent was deemed unnecessary because all personal data was de-identified prior to the analysis. Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable not detected. Table 2: Resources
No key resources detected.
Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:Our study has certain limitations. This study was observational and no control group was utilized for comparison. We did not …
SciScore for 10.1101/2020.06.05.20122622: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement Consent: Informed consent was deemed unnecessary because all personal data was de-identified prior to the analysis. Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable not detected. Table 2: Resources
No key resources detected.
Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:Our study has certain limitations. This study was observational and no control group was utilized for comparison. We did not evaluate the relationship between IL-6 levels and tocilizumab efficacy as these levels were infrequently available at the time of dosing. We did not identify any serious adverse drug reactions, but reactivation of hepatitis B or latent tuberculosis were not formally evaluated. As with all critically ill patients, multiple therapeutic modalities are implemented concurrently in an attempt to minimize morbidity and mortality. Similarly, the patients who received tocilizumab were also treated with antibiotics, anticoagulants, and steroid therapy in varying combinations. Accordingly, it is difficult to identify the most clinically influential modality. Further randomized studies will be needed to answer this question. In the absence of definitive data, this study should serve as a guidepost to those striving to identify the utility of tocilizumab in the therapeutic armamentarium. While the optimal time to dose tocilizumab has not been previously established, our data strongly supports a mortality benefit of dosing tocilizumab early and within 1 day of intubation. Accordingly, we strongly encourage the use of this agent earlier in the COVID-19 treatment spectrum.
Results from TrialIdentifier: No clinical trial numbers were referenced.
Results from Barzooka: We did not find any issues relating to the usage of bar graphs.
Results from JetFighter: We did not find any issues relating to colormaps.
Results from rtransparent:- Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
- Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
- No protocol registration statement was detected.
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