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.

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There are a growing number of school-based interventions designed to promote children's social and emotional learning. One such intervention, PATHS (Promoting Alternative Thinking Strategies), was evaluated in a randomised controlled trial involving 5,074 pupils aged 4-6 years at baseline in 56 primary schools across a large city in the UK. The programme was implemented for two academic years. The primary outcome measure was the teacher-rated Strengths and Difficulties Questionnaire (SDQ). A secondary measure was the PATHS Teacher Rating Scale (PTRS). Observations of child and teacher behaviours were undertaken in a third of intervention and control schools using the Teacher-Pupil Observation Tool (T-POT). Regarding fidelity, dose and adherence were measured via weekly logs completed by teachers, and a semi-structured questionnaire completed by PATHS coaches was used as a global measure of fidelity (capturing adherence, dose and quality). A cost-consequence analysis examined programme costs from a multi-agency public sector perspective. At one year post-baseline there were no statistically significant differences between the programme and control groups on the SDQ subscales or the SDQ total difficulties and impact scores. There were statistically significant differences favouring the programme group for six out of 11 sub-scales on the secondary outcome measure (PTRS). At two years post-baseline, there were no statistically significant differences between the groups on either measure. Fidelity, according to the global measure, was relatively strong, and there was no relationship between fidelity and treatment effects. The average cost of PATHS was £12,666 per school or £139 per child. The study, which was fully powered and independent of the programme developer, shows no statistically significant effect of the programme on child behaviour or emotional well-being.3

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