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 objective of this study was to analyse associations between sexualised substance use (chemsex), STI diagnoses and sexual behaviour among gay bisexual and other men who have sex with men accessing sexual health clinics to better inform clinical pathways. A retrospective case notes review was undertaken following the introduction of more detailed and holistic profomas for all gay bisexual and other men who have sex with men attending two London sexual health clinics between 1 June 2014 and 31 January 2015. Chemsex status was documented for 655/818. Overall, 30% disclosed recreational drug use of whom 113 (57%) disclosed chemsex and 27 (13.5%) injecting drugs. HIV-positive gay bisexual and other men who have sex with men were more likely to disclose chemsex (AOR 6.68; 95% CI 3.91-11.42; p< 0.001). Those disclosing chemsex had a higher incidence of acute bacterial STIs (AOR 2.83 CI 1.79-4.47; p < 0.001), rectal STIs (AOR 3.10 CI 1.81-5.32; p < 0.001) or hepatitis C (AOR 15.41 CI 1.50-158.17; p = 0.021). HIV incidence in the study period was 1.8% (chemsex) vs. 0.9% (no chemsex) (p = 0.61). Chemsex was associated with having more sexual partners, transactional sex, group sex, fisting, sharing sex toys, injecting drug use, higher alcohol consumption and the use of 'bareback' sexual networking applications (p < 0.004). Chemsex participants were also more likely to have accessed post-exposure prophylaxis for HIV in the study period and report sex with a discordant HIV or hepatitis C-infected partner (p < 0.001). Chemsex disclosure is associated with higher risk-taking behaviours, acute bacterial STIs, rectal STIs and hepatitis C incidence. HIV incidence was higher but not significantly so in the study period. Chemsex disclosure in sexual health clinics should prompt an opportunity for prevention, health promotion and wellbeing interventions.
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