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.
As this is a re-submission as a research letter this is no longer relevant, but left in further information Introduction The global SARS CoV2 pandemic resulted in social isolation measures with unintended negative impacts, particularly on mental health. We hypothesised that people with asthma are likely to be more vulnerable to worse mental health during lockdown. Methods We examined COVID-19 surveys (completed April/May 2020), nested within two generations of the Avon Longitudinal Study of Parents and Children (ALSPAC): index-generation ALSPAC-G1 (n=2942, mean age=28) and the parent's generation ALSPAC-G0 (n=3737, mean age=59). We used Poisson and logistic regression models to estimate the effect of asthma on wellbeing, anxiety and depression, and factors related to COVID-19 and lockdown. Models were adjusted for validated pre-pandemic measures of mental health and socio-economic factors. Results Asthma was associated with a 13% increase in depression score in ALSPAC-G1 (p=0.005) and 15% increase in ALSPAC-G0 (p=0.05) compared to participants without asthma, anxiety scores increased by 14% in ALSPAC-G1 (p=0.005) and by 16% in ALSPAC-G0 (p=0.02). Asthma was associated with a similar increase of anxiety and depression scores during COVID-19 in both generations (Z test p values >0.80). Discussion People with asthma have worse mental health & wellbeing during lockdown compared to people without asthma. Although the effect of asthma on mental health is of similar magnitude between the generations, younger participants with asthma declined to lower levels of mental health despite reporting less symptoms, COVID-19 infection and self-isolation. This has important implications given repeated lockdowns. Young people with asthma should be closely monitored and supported to mitigate the impact of lockdown on their mental health.
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