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.
Objective: To collect data on incidents of potential or actual harm to general practice patients and to evaluate the possible causes of these incidents.
Design: An observational study of incidents of potential harm based on a modified critical incidents technique. A non‐random sample of general practitioners (GPs) anonymously submitted incident reports contemporaneously.
Setting and participants: Australian general practices between October 1993 and June 1995. During the study period, 324 GPs participated at some time.
Main outcome measures: GP‐reported free‐text descriptions of incidents and structured responses for preventability, potential for harm, immediate consequences, predicted long‐term outcomes, type of incident, contributing factors, mitigating factors, and additional resource use.
Results: 805 incidents were reported −76% were preventable; 27% had potential for severe harm. No long term harm was predicted for 66% of incidents. Incidents could relate to pharmacological management (51 per 100 incidents), non pharmacological management (42 per 100 incidents), diagnosis (34 per 100 incidents) or equipment (5 per 100 incidents). The most common contributory factors were poor communication between patients and healthcare professionals and actions of others (23 per 100 incidents each) and errors in judgement (22 per 100 incidents).
Conclusion: Human errors and preventable system problems were identified. The incident monitoring technique provided useful data which could be applied to incident prevention strategies.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.