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.
BACKGROUND: In an elderly population of surgical patients, poor mobility, poor diet and chronic disease contribute to a significant risk of malnutrition. Malnutrition is associated with muscle weakness, fatigue, poor wound healing and immunological dysfunction. The aim of the study was to establish the prevalence of malnutrition in vascular surgical patients and to compare postoperative infection rates in well nourished and malnourished patients. METHODS: A nutritional assessment was performed on 71 patients (49 men; median age 65 (range 26-85) years) attending preassessment for vascular surgical procedures. Nutritional status was measured using validated indicators of malnutrition: estimated weight changes over 3 months; body mass index; mid-arm muscle circumference (MAMC) calculated using triceps skin fold thickness (TSF) and mid-arm circumference (MAC) (MAMC = MAC - (3.14 x TSF)); and serum albumin concentration. Fifty-nine patients were followed after vascular surgery. The incidence of postoperative infections was related to preoperative nutritional status. RESULTS: Nineteen patients (27 per cent) had normal values for all nutritional indicators examined. The remaining 52 patients (73 per cent) had one (37), two (12), three (two) or four (one) nutritional indicators within the range for malnutrition. Among the 59 patients who underwent surgery there were five chest infections, seven wound infections, one urinary tract infection and one infected central line in 13 patients following six femorodistal bypasses, four abdominal aortic aneurysm repairs and three miscellaneous arterial procedures. The incidence of septic complications was zero in 14 patients with normal nutritional indicators and 41 per cent (13 of 32) in patients with indicators of malnutrition (P < 0.05, Fisher's exact test). CONCLUSION: Malnutrition is prevalent among vascular patients and may contribute to postoperative morbidity. Malnourished patients should be identified and referred to the dietician at the earliest opportunity to minimize the morbid effects of undernutrition.
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