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

An Investigation into the High Prevalence of Hepatitis B in a Rural Area of Kerala State, India: Hypothesis on Chrysops sp. (Diptera: Tabanidae) Transmission

Objective. Since 2005 there have been several reports of hepatitis B outbreak in the state of Kerala in southern India. Objective of this study was to analyze such outbreaks and to explore hypothesis pertaining the transmission mode. Methods. Retrospective observational study involving cases of acute hepatitis B acquired between 1 January 2015 and 31 December 2015 and their family members residing in Mazhuvanoor village in Ernakulam district of Kerala State in southern India. Results. 59 houses were included in the survey. The number of patients diagnosed to have acute viral hepatitis B was 59. Majority (66.10%) were over 50 years old. There were no cases below the age of 15 years. All 59 patients claimed to have been bitten frequently by a fly which was identified as “deer fly” belonging to the genus Chrysops. Conclusion. Given the current understanding of mechanical transmission of pathogens in both humans and animals by insects belonging to the Tabanidae family which also includes Chrysops, it is plausible that the same mechanism may hold true for hepatitis B also. However this needs to be proven in further studies both at the laboratory level and at field studies

Apolipoprotein E polymorphism and outcome after mild to moderate traumatic brain injury: A study of patient population in India

Background: The nature and extent of recovery after traumatic brain injury (TBI) is heterogeneous. Apolipoprotein E (APOE) plays a major role in repair of cell membrane and growth of neurites following injury to cells. Studies done on the western population have shown that the APOE e4 genotype is associated with poor survival following neurotrauma. Aim: To explore the association of APOE polymorphism and outcome following TBI in a patient population from a tertiary care hospital exclusive for neurological diseases in south India. Patients and Methods: Ninety eight patients who sustained mild to moderate TBI (computed tomography (CT) scan brain showing traumatic parenchymal contusions) were the subjects of the study and the study period was from November 2003 to December 2008. APOE polymorphism status was determined by PCR technique using venous blood. Patients were assessed on follow-up with a battery of four neuropsychological tests as well as Glasgow outcome scale. Results: Of the 98 patients, 20 (20%) patients had at least one APOE e4 allele. A follow-up of minimum six months was available for 73 patients. None of the12 patients who had at least one APOE e4 allele had a poor outcome at six-month follow-up whereas 11(18%) patients without an APOE e4 allele had a poor outcome (Fisher′s Exact test, P=0.192). On the neuropsychological tests, performance of patients with APOE e4 allele did not differ significantly from those without these alleles. Conclusion: This study does not support the current contention that the presence of APOE e4 allele should have a significant negative effect on the outcome after TBI