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.

indicate that attitudes among the medical profession and patients are changing.There has been much discussion about clinical trials and informed consent,46 and, though we believe that informed consent is mandatory, we accept that a proportion of patients do not enter trials because they may dislike the idea of a random decision being made about treatment or because they refuse or request one part of the random option offered. A further group of patients are excluded because they do not fulfil the entry criteria for the trial, and this group may be larger than forecast at the time the trial was planned. These factors may be the reason why accrual to the Scottish breast conservation trial has been slower than anticipated. The planned total intake was 900 patients, and after four years 420 patients had been entered.In conclusion more than half of the patients thought initially to be suitable for conservation were excluded from our trials and one third of the remainder refused to take part. Those planning prospective clinical trials should therefore take into account the loss of patients through ineligibility and refusal when predicting the accrual rate and overall duration of any proposed trial and the possible effects of this selection on conclusions drawn from the results. Design-A study of all infants dying suddenly and unexpectedly and of two controls matched for age and date with each index case. The parents of control infants were interviewed within 72 hours of the index infant's death. Information was collected on bedding, sleeping position, heating, and recent signs of illness for index and control infants.Setting-A defined geographical area comprising most of the county of Avon and part of Somerset.Subjects-72 Infants who had died suddenly and unexpectedly (of whom 67 had died from the sudden infant death syndrome) and 144 control infants.Results-Compared with the control infants the infants who had died from the sudden infant death syndrome were more likely to have been sleeping prone (relative risk 8-8; 95% confidence interval 7.0 to 11-0; p<0-001), to have been more heavily wrapped (relative risk 1-14 per tog above 8 tog; 1-03 to 1-28; p<005), and to have had the heating on all night (relative risk 2-7; 1-4 to 5.2; p<0-01). These differences were less pronounced in the younger infants (less than 70 days) than the older ones. The risk of sudden unexpected death among infants older than 70 days, nursed prone, and with clothing and bedding of total thermal resistance greater than 10 tog was increased by factors of 15-1 (2.6 to 89.6) and 25-2 (3.7 to 169-0) respectively compared with the risk in

No abstract

No abstract

No abstract