Background
In this study, we aimed to evaluate the effects of tocilizumab in adult patients admitted to hospital with COVID-19 with both hypoxia and systemic inflammation.
Methods
This randomised, controlled, open-label, platform trial (Randomised Evaluation of COVID-19 Therapy [RECOVERY]), is assessing several possible treatments in patients hospitalised with COVID-19 in the UK. Those trial participants with hypoxia (oxygen saturation <92% on air or requiring oxygen therapy) and evidence of systemic inflammation (C-reactive protein ≥75 mg/L) were eligible for random assignment in a 1:1 ratio to usual standard of care alone versus usual standard of care plus tocilizumab at a dose of 400 mg–800 mg (depending on weight) given intravenously. A second dose could be given 12–24 h later if the patient's condition had not improved. The primary outcome was 28-day mortality, assessed in the intention-to-treat population. The trial is registered with ISRCTN (50189673) and
ClinicalTrials.gov
(
NCT04381936
).
Findings
Between April 23, 2020, and Jan 24, 2021, 4116 adults of 21 550 patients enrolled into the RECOVERY trial were included in the assessment of tocilizumab, including 3385 (82%) patients receiving systemic corticosteroids. Overall, 621 (31%) of the 2022 patients allocated tocilizumab and 729 (35%) of the 2094 patients allocated to usual care died within 28 days (rate ratio 0·85; 95% CI 0·76–0·94; p=0·0028). Consistent results were seen in all prespecified subgroups of patients, including those receiving systemic corticosteroids. Patients allocated to tocilizumab were more likely to be discharged from hospital within 28 days (57%
vs
50%; rate ratio 1·22; 1·12–1·33; p<0·0001). Among those not receiving invasive mechanical ventilation at baseline, patients allocated tocilizumab were less likely to reach the composite endpoint of invasive mechanical ventilation or death (35%
vs
42%; risk ratio 0·84; 95% CI 0·77–0·92; p<0·0001).
Interpretation
In hospitalised COVID-19 patients with hypoxia and systemic inflammation, tocilizumab improved survival and other clinical outcomes. These benefits were seen regardless of the amount of respiratory support and were additional to the benefits of systemic corticosteroids.
Funding
UK Research and Innovation (Medical Research Council) and National Institute of Health Research.
BackgroundDepressive disorders are leading contributors to burden of disease in developing countries. Research aiming to improve their diagnosis and treatment is fundamental in these settings, and psychometric tools are widely used instruments to support mental health research. Our aim is to validate and compare the psychometric properties of the Spanish versions of the Center for Epidemiological Studies Depression Scale (CES-D) and the Zung Self-Rating Depression Scale (ZSDS).Methodology/Principal FindingsA Spanish version of the CES-D was revised by 5 native Spanish speaking psychiatrists using as reference the English version. A locally standardized Spanish version of the ZSDS was used. These Spanish versions were administered to 70 patients with a clinical diagnosis of DSM-IV Major Depressive Episode (MDE), 63 without major depression but with clinical diagnosis of other psychiatric disorders (OPD), and 61 with no evidence of psychiatric disorders (NEP). For both scales, Cronbach's alpha (C-α) and Hierarchical McDonald Omega for polychoric variables (MD-Ω) were estimated; and receiver operating characteristics (ROC) analysis performed. For the CES-D and ZSDS scales, C-α was 0.93 and 0.89 respectively, while MD-Ω was 0.90 and 0.75 respectively. The area under the ROC curve in MDE+OPD was 0.83 for CES-D and 0.84 for ZSDS; and in MDE+NEP was 0.98 for CES-D and 0.96 for ZSDS. Cut-off scores (co) for the highest proportions of correctly classified (cc) individuals among MDE+OPD were ≥29 for CES-D (sensitivity (ss) = 77.1/specificity (sp) = 79.4%/(cc) = 78.2%) and ≥47 for ZSDS (ss = 85.7%/sp = 71.4%/cc = 78.9%). In the MDE+NEP, co were ≥24 for the CES-D (ss = 91.4%/sp = 96.7%/cc = 93.9%) and ≥45 for the ZSDS (ss = 91.4%/sp = 91.8%/cc = 91.6%).ConclusionSpanish versions of the CES-D and ZSDS are valid instruments to detect depression in clinical settings and could be useful for both epidemiological research and primary clinical settings in settings similar as those of public hospitals in Lima, Peru.
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