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

SummaryBackground Azithromycin has been proposed as a treatment for COVID-19 on the basis of its immunomodulatoryactions. We aimed to evaluate the safety and efficacy of azithromycin in patients admitted to hospital with COVID-19.Methods In this randomised, controlled, open-label, adaptive platform trial (Randomised Evaluation of COVID-19Therapy [RECOVERY]), several possible treatments were compared with usual care in patients admitted to hospitalwith COVID-19 in the UK. The trial is underway at 176 hospitals in the UK. Eligible and consenting patients wererandomly allocated to either usual standard of care alone or usual standard of care plus azithromycin 500 mg once perday by mouth or intravenously for 10 days or until discharge (or allocation to one of the other RECOVERY treatmentgroups). Patients were assigned via web-based simple (unstratified) randomisation with allocation concealment andwere twice as likely to be randomly assigned to usual care than to any of the active treatment groups. Participants andlocal study staff were not masked to the allocated treatment, but all others involved in the trial were masked to theoutcome data during the trial. The primary outcome was 28-day all-cause mortality, assessed in the intention-to-treatpopulation. The trial is registered with ISRCTN, 50189673, and ClinicalTrials.gov, NCT04381936.Findings Between April 7 and Nov 27, 2020, of 16 442 patients enrolled in the RECOVERY trial, 9433 (57%) wereeligible and 7763 were included in the assessment of azithromycin. The mean age of these study participants was65·3 years (SD 15·7) and approximately a third were women (2944 [38%] of 7763). 2582 patients were randomlyallocated to receive azithromycin and 5181 patients were randomly allocated to usual care alone. Overall,561 (22%) patients allocated to azithromycin and 1162 (22%) patients allocated to usual care died within 28 days(rate ratio 0·97, 95% CI 0·87–1·07; p=0·50). No significant difference was seen in duration of hospital stay (median10 days [IQR 5 to >28] vs 11 days [5 to >28]) or the proportion of patients discharged from hospital alive within 28 days(rate ratio 1·04, 95% CI 0·98–1·10; p=0·19). Among those not on invasive mechanical ventilation at baseline, nosignificant difference was seen in the proportion meeting the composite endpoint of invasive mechanical ventilationor death (risk ratio 0·95, 95% CI 0·87–1·03; p=0·24).Interpretation In patients admitted to hospital with COVID-19, azithromycin did not improve survival or otherprespecified clinical outcomes. Azithromycin use in patients admitted to hospital with COVID-19 should be restrictedto patients in whom there is a clear antimicrobial indication

Posttraumatic Growth in Coronary Artery Disease Outpatients: Relationship to Degree of Trauma and Health Service Use

Objectives Posttraumatic growth (PTG) is frequently reported after the strike of a serious medical illness. The current study sought to: 1) assess the relationship between degree of cardiac “threat” and PTG one year post-hospitalization; and 2) to explore the association between PTG and healthcare utilization. Methods In a cohort study, 2636 cardiac inpatients from 11 Ontario hospitals completed a sociodemographic survey,; clinical data were extracted from charts. One year later, 1717 of these outpatients completed a postal survey, which assessed PTG and healthcare utilization. Morbidity data were obtained retrospectively through probabilistic linkage to administrative data. The predicted risk of recurrent events for each participant was calculated using a logistic regression model, based on participants’ sociodemographic and clinical characteristics. The relationship among PTG, trauma and health service use was examined with multiple regression models. Results Greater PTG was significantly related to greater predicted risk of recurrent events (p<.001), but not the actual rate of recurrent events (p=.117). Moreover, greater PTG was significantly related to more physician visits (p=.006), and cardiac rehabilitation program enrolment (p=.001) after accounting for predicted risk and sociodemographic variables. PTG was not related to urgent healthcare use. Conclusions Greater PTG was related to greater objective risk of morbidity but not actual morbidity, suggesting that contemplation about the risk of future health problems may spur PTG. Moreover, greater PTG was associated with seeking non-urgent healthcare. Whether this translates to improved health outcomes warrants future study.Canadian Institutes of Health Research Institute of Gender and Health (CIHR) and The Heart and Stroke Foundation of Canada Grant # HOA-80676