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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BackgroundA Core Outcome Set (COS) is an agreed list of outcomes that are measured and reported in all clinical trials for a particular health condition. An ‘e-Delphi’ is an increasingly popular method for developing a COS whereby stakeholders are consulted via a multi-round online survey to reach agreement regarding the most important outcomes. Many COS studies seek diverse, international input that includes professionals and healthcare users. However, the recruitment and retention of participants can be deterred by various factors (e.g. language barriers and iterative, time-consuming rounds). This report evaluates the effectiveness of recruitment and retention methods used in the Core Outcome Measures in Tinnitus International Delphi (COMiT’ID) study using participant feedback from healthcare users, healthcare practitioners, researchers, commercial representatives and funders.MethodsA range of methods were applied to recruit participants to the study and maintain engagement over the three rounds. Feedback on recruitment and retention methods was collected using a twenty-item online questionnaire, with free text comments.ResultsA personalised email invitation was the most frequent recruitment route, and 719 professionals and healthcare users consented to take part. Retention of each stakeholder group ranged from 76 to 91% completing all three e-Delphi rounds. Feedback was given by 379 respondents. A majority of respondents were satisfied with the study methods that were implemented to promote retention. Over 55% indicated that their overall experience closely matched their expectations at the start of the study, and over 90% felt that their contribution was appreciated.ConclusionsThis report highlights study methods that worked well with respect to recruitment and retention, and those that did not. Findings provide a unique contribution to the growing evidence base of good practice in COS development by demonstrating the relative effectiveness of recruitment and retention methods for an e-Delphi survey.Trial registrationThis project was registered (November 2014) in the database of the Core Outcome Measures in Effectiveness Trials (COMET) initiative. The protocol is published in Trials (doi:10.1186/s13063-017-2123-0).

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