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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Although aspects of mindfulness are associated with depression and anxiety following an episode of psychosis, psychological flexibility appears to account for a larger proportion of variance in depression and anxiety scores in this population.

Depression following psychosis is common and can impact negatively on individuals' quality of life. This study conducted post-hoc analyses on 14 participants with psychosis from a larger randomised controlled trial who presented with clinically important levels of depression at baseline. Eight of the participants received Acceptance and Commitment Therapy (ACT), whilst the remaining six individuals received treatment as usual (TAU). The focus was on investigating clinically significant change in outcome measures between baseline and 3-months post-baseline in the participants. Participants completed measures assessing depression and anxiety (HADS), psychosis symptoms (PANSS) and psychological inflexibility (AAQ-II) between baseline and at 3-month post-baseline assessments. Odds ratio analysis indicated that participants receiving ACT, compared to TAU, were 15 times more likely to achieve clinically significant decreases in depression scores (Fisher's Exact Test p = 0.05). Differences between the ACT and TAU groups in clinically significant changes in anxiety, psychological inflexibility, positive symptoms, negative symptoms and general level of psychopathology were not statistically significant. The study provides tentative support for the use of ACT to treat depression emerging in the context of psychosis.

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ISRCTN: 33306437.