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

The Association Of Type Of Surgical Closure On Length Of Stay Among Infants With Gastroschisis Born ≥ 34 Weeks\u27 Gestation

Background/Purpose The optimal surgical approach in infants with gastroschisis (GS) is unknown. The purpose of this study was to estimate the association between staged closure and length of stay (LOS) in infants with GS. Design/Methods We used the Children\u27s Hospital Neonatal Database to identify surviving infants with GS born ≥ 34 weeks\u27 gestation referred to participating NICUs. Infants with complex GS, bowel atresia, or referred after 2 days of age were excluded. The primary outcome was LOS; multivariable linear regression was used to quantify the relationship between staged closure and LOS. Results Among 442 eligible infants, staged closure occurred in 68.1% and was associated with an increased median LOS relative to odds ration (OR):primary closure (37 vs. 28 days, p \u3c 0.001). This association persisted in the multivariable equation (β = 1.35, 95% CI: 1.21, 1.52, p \u3c 0.001) after adjusting for the presence of necrotizing enterocolitis, short bowel syndrome, and central-line associated bloodstream infections. Conclusions In this large, multicenter cohort of infants with GS, staged closure was independently associated with increased LOS. These data can be used to enhance antenatal and pre-operative counseling and also suggest that some infants who receive staged closure may benefit from primary repair. © 2014 Elsevier Inc

PTSD Risk Factors and Acute Pain Intensity Predict Length of Hospital Stay in Youth after Unintentional Injury

Background: Many hospitals have adopted screening tools to assess risk for posttraumatic stress disorder (PTSD) after pediatric unintentional injury in accordance with American College of Surgeons recommendations. The Screening Tool for Early Predictors of PTSD (STEPP) is a measure initially developed to identify youth and parents at high risk for meeting diagnostic criteria for PTSD after injury. Acute pain during hospitalization has also been examined as a potential predictor of maladaptive outcomes after injury, including PTSD. We investigated in a retrospective cohort study whether the STEPP, as well as acute pain intensity during hospitalization, would predict maladaptive outcomes during the peri-trauma in addition to the post-trauma period, specifically length of hospitalization. Methods: A total of 1123 youths aged 8–17 (61% male) and their parents were included. Patients and parents were administered the STEPP for clinical reasons while hospitalized. Acute pain intensity and length of stay were collected through retrospective chart review. Results: Adjusting for demographics and injury severity, child but not parent STEPP total predicted length of stay. Acute pain intensity, child threat to life appraisal, and child pulse rate predicted length of stay. Conclusions: Acute pain intensity and child PTSD risk factors, most notably child threat to life appraisal, predicted hospitalization length above and beyond multiple factors, including injury severity. Pain intensity and child appraisals may not only serve as early warning signs for maladaptive outcomes after injury but also indicate a more difficult trajectory during hospitalization. Additional assessment and treatment of these factors may be critical while youth are hospitalized. Utilizing psychology services to support youth and integrating trauma-informed care practices during hospitalization may support improved outcomes for youth experiencing unintentional injury