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.
An experiment was carried out in which patients who were seeking appointments for a consultation in a general practice in south London attended consulting sessions booked at 5, 7.5, or 10 minute intervals. The particular session that the patient attended was determined non-systematically. The clinical content of the consultation was recorded on an encounter sheet and on audio-tape. At the end of each consultation patients were invited to complete a questionnaire designed to measure satisfaction with the consultation. The stress engendered in doctors carrying out surgery sessions booked at different intervals of time was also measured. At surgery sessions booked at 5 minute intervals, compared with 7.5 and 10 minute intervals, the doctors spent less time with the patients and identified fewer problems, and the patients were less satisfied with the consultation. Blood pressure was recorded twice as often in surgery sessions that were booked at 10 minute intervals compared with those booked at 5 minute intervals. There was no evidence that patients who attended sessions booked at shorter intervals received more prescriptions, were investigated or referred more often to hospital specialists, or returned more often for further consultations within four weeks. There was no evidence that the doctors experienced more stress in dealing with consultations that were booked at 5 minute intervals than at consultations booked at 7.5 and 10 minute intervals, though they complained of shortage of time more often in surgery sessions that were booked at shorter intervals.
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