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
Children are usually mildly affected by severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2, COVID‐19). However, the pandemic has caused collateral damage to those with non‐COVID‐19 diseases. We aimed to determine the impact of the COVID‐19 pandemic on the presentation of newly diagnosed childhood onset type 1 diabetes.
Methods
This was a cross‐sectional study conducted over a 1‐year period. We compared the severity of presentation of new‐onset type 1 diabetes in children under the age of 18 presenting to the multi‐centre North Central London diabetes network before (1 July 2019 to 22 March 2020) and during (23 March 2020 to 30 June 2020) the first wave of the COVID‐19 pandemic in the United Kingdom.
Results
Over the 1‐year study period, a total of 30 children presented with new‐onset type 1 diabetes during the pre‐pandemic period and 17 presented during the first COVID‐19 wave. Children presented more frequently in diabetic ketoacidosis (DKA) during the first COVID‐19 wave compared with pre‐pandemic (pre‐pandemic: mild 13%, moderate 6.7%, severe 10%; first COVID‐19 wave: mild 5.9%, moderate 24%, severe 47%; p = 0.002). During the first COVID‐19 wave, DKA presentations in children with a family history of type 1 diabetes were fewer compared to those without a family history (33.3% vs. 100.0%; p = 0.006). Children presenting in severe DKA pre‐pandemic were younger than those not in severe DKA (3.9 years vs. 12.2 years, p < 0.001) but this difference was not significant during the first COVID‐19 wave (10.1 years vs. 11.2 years, p = 0.568). Presenting HbA1c measurement was higher in those presenting during the first COVID‐19 wave (13.0 ± 1.7 vs. 10.4 ± 3.2%; 119 ± 19 vs. 90 ± 35 mmol/mol; p = 0.008).
Conclusion
The COVID‐19 pandemic is associated with increased severity of presentation of childhood onset type 1 diabetes. Whatever the context, young people with suspected new‐onset type 1 diabetes should be referred for urgent clinical review.
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