4 research outputs found

    Convalescent plasma in patients admitted to hospital with COVID-19 (RECOVERY): a randomised controlled, open-label, platform trial

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    Background: Many patients with COVID-19 have been treated with plasma containing anti-SARS-CoV-2 antibodies. We aimed to evaluate the safety and efficacy of convalescent plasma therapy in patients admitted to hospital with COVID-19. 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. The trial is underway at 177 NHS hospitals from across the UK. Eligible and consenting patients were randomly assigned (1:1) to receive either usual care alone (usual care group) or usual care plus high-titre convalescent plasma (convalescent plasma group). The primary outcome was 28-day mortality, analysed on an intention-to-treat basis. The trial is registered with ISRCTN, 50189673, and ClinicalTrials.gov, NCT04381936. Findings: Between May 28, 2020, and Jan 15, 2021, 11558 (71%) of 16287 patients enrolled in RECOVERY were eligible to receive convalescent plasma and were assigned to either the convalescent plasma group or the usual care group. There was no significant difference in 28-day mortality between the two groups: 1399 (24%) of 5795 patients in the convalescent plasma group and 1408 (24%) of 5763 patients in the usual care group died within 28 days (rate ratio 1·00, 95% CI 0·93–1·07; p=0·95). The 28-day mortality rate ratio was similar in all prespecified subgroups of patients, including in those patients without detectable SARS-CoV-2 antibodies at randomisation. Allocation to convalescent plasma had no significant effect on the proportion of patients discharged from hospital within 28 days (3832 [66%] patients in the convalescent plasma group vs 3822 [66%] patients in the usual care group; rate ratio 0·99, 95% CI 0·94–1·03; p=0·57). Among those not on invasive mechanical ventilation at randomisation, there was no significant difference in the proportion of patients meeting the composite endpoint of progression to invasive mechanical ventilation or death (1568 [29%] of 5493 patients in the convalescent plasma group vs 1568 [29%] of 5448 patients in the usual care group; rate ratio 0·99, 95% CI 0·93–1·05; p=0·79). Interpretation: In patients hospitalised with COVID-19, high-titre convalescent plasma did not improve survival or other prespecified clinical outcomes. Funding: UK Research and Innovation (Medical Research Council) and National Institute of Health Research

    Tocilizumab in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial

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    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

    Comparison of obstetric anal sphincter injuries in nulliparous women before and after introduction of the EPISCISSORS-60® at two hospitals in the United Kingdom

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    Yves van Roon,1 Ciara Kirwin,2 Nadia Rahman,3 Latha Vinayakarao,2 Louise Melson,2 Nikki Kester,1 Sangeeta Pathak,1 Ashish Pradhan1 1Department of Obstetrics and Gynecology, Hinchingbrooke Hospital, Huntingdon, 2Department of Obstetrics and Gynecology, Poole Hospital, Poole, 3Department of Obstetrics and Gynecology, Addenbrookes Hospital, Cambridge, UK Aim: To assess whether the introduction of episiotomy scissors specially designed to achieve a cutting angle of 60°, EPISCISSORS-60®, in two hospitals in the UK would result in a reduction in obstetric anal sphincter injuries (OASIS) in nulliparous women.Methods: A structured training program for all doctors and midwives provided a theoretical framework around OASIS including risk factors and the role of episiotomies and a practical hands-on training element to use EPISCISSORS-60® correctly and to measure perineal body length and post-suturing angles. Data for perineal body length, post-suturing angles, user feedback, episiotomy use, and incidence of OASIS were collected through specifically designed forms and the general hospital data collection system.Results: Data were available for 838 nulliparous vaginal deliveries. Mean perineal body length was 37 mm in spontaneous vaginal delivery group (standard deviation [SD] =8.3, 95% confidence interval [CI] =34–39) and 38 mm in the operative vaginal delivery group (SD=8, 95% CI=35–40). Post-suturing episiotomy angles were 53° (SD=6.5, 95% CI=50.7–55.8) in spontaneous vaginal deliveries and 52° (SD=9.6, 95% CI=49–54) in operative vaginal deliveries. EPISCISSORS-60® were rated as “good” to “very good” by 84% of users. There was a 47% increase in the number of episiotomies in nulliparous spontaneous vaginal deliveries at Poole (P=0.007) and a 16.5% increase in the number of episiotomies in nulliparous operative vaginal deliveries in Hinchingbrooke (P=0.003). There was an overall 11% increase in episiotomy numbers in nulliparous vaginal deliveries (P=0.08). There was a statistically significant OASIS reduction of 84% in nulliparous spontaneous vaginal deliveries in women who received an episiotomy (P=0.003).Conclusion: Initial results after introduction of EPISCISSORS-60® show that the majority of health care professionals achieve post-suturing episiotomy angles between 40° and 60°. The results also show a significant increase in the use of episiotomies in the delivery of nulliparous women. There has been a statistically significant reduction in OASIS in nulliparous spontaneous vaginal deliveries. Keywords: EPISCISSORS-60®, episiotomy, obstetric anal sphincter injury, perineal body length, post-episiotomy suturing angle, nulliparous wome
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