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.
IntroductionThe first case of novel SARS-COV-2 (COVID-19) in Pakistan was detected on 26 February 2020. Pharmacological and non-pharmacological strategies have been tried to lessen the mortality and morbidity burden. Various vaccines have been approved. The Drug Regulatory Authority of Pakistan gave emergency approval for Sinopharm (BBIBP-CorV) COVID-19 vaccine in December 2021. The phase 3 trial of BBIBP-CorV included only 612 participants aged 60 years and above. The primary aim of this study was to assess the safety and efficacy of BBIBPP-CorV (Sinopharm) vaccine within the Pakistani adult population aged 60 or above. The study was carried out in the Faisalabad district of Pakistan.MethodsA test negative case–control study design was used to assess safety and efficacy of BBIBP-CorV in individuals aged 60 and above against symptomatic infection, hospitalisations and mortality due to SARS-CoV-2 among vaccinated and unvaccinated individuals. ORs were calculated using logistic regression model at 95% CI. ORs were used to calculate the vaccine efficacy (VE) by using the following formula.VE= (1-OR) ×100.Results3426 individuals with symptoms of COVID-19 were PCR tested between 5 May 2021 and 31 July 2021. The results showed that Sinopharm vaccine 14 days after the second dose was efficient in reducing the risk of symptomatic COVID-19 infection, hospitalisations and mortality by 94.3%, 60.5% and 98.6%, respectively, among vaccinated individuals with a significant p value of 0.001.ConclusionOur study showed that BBIBP-CorV vaccine is highly effective in preventing infection, hospitalisations and mortality due to COVID-19.
Biologic agents are increasingly used for many autoimmune and inflammatory conditions, as they are both steroid sparing and can potentially induce and maintain remission. Notably tumor necrosis factor (TNF) alpha antagonists are particularly useful in inflammatory bowel disease (IBD) such as Crohn’s disease (CD) and ulcerative colitis (UC).
Infliximab is a chimeric monoclonal antibody that targets TNF alpha (cytokine involved in modulation of inflammatory responses) and neutralizes its effects. As infliximab is a generic TNF alpha inhibitor, it can cause non-specific immune mediated side effects in addition to its intended therapeutic effect on the target organ (i.e., the gut in IBD).
We present a case of a gentleman developing a rare dermatological side effect of an acneiform reaction, after the use of infliximab for his CD. Monitoring anti-TNF alpha antibodies may help identify patients at a higher risk of developing adverse reactions. In addition, gut specific biologic agents (vedolizumab) may be the next preferable step in individuals with IBD who demonstrate reactions and/or intolerance to non-specific TNF alpha inhibitors.
Introduction DECAF is a scoring tool that can predict severity in patients with an acute exacerbation of chronic obstructive pulmonary disease (AECOPD). Previous research has shown AECOPD patients with DECAF scores of 0-1 are candidates for early discharge. Methods Plan, do, study, act (PDSA) methodology was used. Patients with AECOPD and a DECAF score of 0-1 were included. Notes were retrospectively reviewed for patients for DECAF score, length of stay, 30-day re-admission and 30-day mortality (PDSA cycle 1). A framework to facilitate early discharge for patients was subsequently established. Awareness was increased through teaching sessions, posters and targeted emails. To evaluate our improvements, the same parameters were collected prospectively (PDSA cycle 2). Results DECAF score was assessed for no patients in PDSA cycle 1 (n=20) but was assessed for all patients in PDSA cycle 2 (n=14). Hospital stay was significantly decreased in PDSA cycle 2 (mean 0.29±0.45 days) compared with PDSA cycle 1 (mean 3.71±2.69 days; difference p<0.00001). Thirty-day re-admission and 30-day mortality was not significantly different between two groups. Conclusion DECAF protocol is safe and feasible in the district general hospital setting and can facilitate early discharge for patients with low severity AECOPD without any worrisome effects.
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