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.
The OHIP-14 in Japanese had a high internal reliability, was significantly associated with dental status and comparable ranking for items when compared with studies from other countries.
These results suggest that tooth loss continues in the very old, that periodontal attachment loss is associated with tooth loss in this age group, and that loss of teeth over one's lifetime does affect certain quality-of-life measures.
Measuring salivary flow rates among the frail elderly is a challenge. The currently used spit collection method requires levels of time and cooperation that often may exclude the frail elderly who are at high risk for salivary compromise. A measurement method that is not only valid and reliable, but also feasible and acceptable is needed for use in population studies of compromised adults. This study compared two salivary flow rate assessment methods using a suction machine against the currently accepted spit collection method in an elderly population aged 75 and older. Three methods of flow rate (g/min) assessment were compared at three time periods among 16 elders (mean age 86.6 years). Flow rates using the 2-min open suction method compared well with the 10-min spit method (r=0.778) but the 2-min closed suction method did not (r=0.158). Reliability evaluation of the open suction method and the spit method was assessed using a test/retest with a 1-week interval. Both methods demonstrated good comparable reliability (spit method r=0.566, P=0.01); open suction method, (r= 0.861, P<0.01). Based on a short survey questionnaire about the three methods, 11 of the 16 elderly subjects preferred the use of the suction machine to the spit method. These results indicate that the 2-min open suction method technique is a valid and reliable means of measuring salivary flow. The lower level of patient cooperation needed, the shorter time period required, and this preliminary report of its acceptability support the use of this method in future population studies of frail elders.
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