ABSTRACT
ObjectivesConvalescent plasma (CP) as a passive source of neutralizing antibodies and immunomodulators is a century-old therapeutic option used for the management of viral diseases. We investigated its effectiveness for the treatment of COVID-19. DesignOpen-label, parallel-arm, phase II, multicentre, randomized controlled trial. SettingThirty-nine public and private hospitals across India. ParticipantsHospitalized, moderately ill confirmed COVID-19 patients (PaO2/FiO2: 200-300 or respiratory rate > 24/min and SpO2 [≤] 93% on room air). InterventionParticipants were randomized to either control (best standard of care (BSC)) or intervention (CP + BSC) arm. Two doses of 200 mL CP was transfused 24 hours apart in the intervention arm. Main Outcome MeasureComposite of progression to severe disease (PaO2/FiO2< 100) or all-cause mortality at 28 days post-enrolment. ResultsBetween 22nd April to 14th July 2020, 464 participants were enrolled; 235 and 229 in intervention and control arm, respectively. Composite primary outcome was achieved in 44 (18.7%) participants in the intervention arm and 41 (17.9%) in the control arm [aOR: 1.09; 95% CI: 0.67, 1.77]. Mortality was documented in 34 (13.6%) and 31 (14.6%) participants in intervention and control arm, respectively [aOR) 1.06 95% CI: -0.61 to 1.83]. InterpretationCP was not associated with reduction in mortality or progression to severe COVID-19. This trial has high generalizability and approximates real-life setting of CP therapy in settings with limited laboratory capacity. A priori measurement of neutralizing antibody titres in donors and participants may further clarify the role of CP in management of COVID-19. Trial registrationThe trial was registered with Clinical Trial Registry of India (CTRI); CTRI/2020/04/024775.
ABSTRACT
The rapid emergence of coronavirus disease 2019 (COVID-19) as a global pandemic affecting millions of individuals globally has necessitated sensitive and high-throughput approaches for the diagnosis, surveillance and for determining the genetic epidemiology of SARS-CoV-2. In the present study, we used the COVIDSeq protocol, which involves multiplex-PCR, barcoding and sequencing of samples for high-throughput detection and deciphering the genetic epidemiology of SARS-CoV-2. We used the approach on 752 clinical samples in duplicates, amounting to a total of 1536 samples which could be sequenced on a single S4 sequencing flow cell on NovaSeq 6000. Our analysis suggests a high concordance between technical duplicates and a high concordance of detection of SARS-CoV-2 between the COVIDSeq as well as RT-PCR approaches. An in-depth analysis revealed a total of six samples in which COVIDSeq detected SARS-CoV-2 in high confidence which were negative in RT-PCR. Additionally, the assay could detect SARS-CoV-2 in 21 samples and 16 samples which were classified inconclusive and pan-sarbeco positive respectively suggesting that COVIDSeq could be used as a confirmatory test. The sequencing approach also enabled insights into the evolution and genetic epidemiology of the SARS-CoV-2 samples. The samples were classified into a total of 3 clades. This study reports two lineages B.1.112 and B.1.99 for the first time in India. This study also revealed 1,143 unique single nucleotide variants and added a total of 73 novel variants identified for the first time. To the best of our knowledge, this is the first report of the COVIDSeq approach for detection and genetic epidemiology of SARS-CoV-2. Our analysis suggests that COVIDSeq could be a potential high sensitivity assay for detection of SARS-CoV-2, with an additional advantage of enabling genetic epidemiology of SARS-CoV-2.
ABSTRACT
BACKGROUND@# Feedback on patient outcomes is invaluable to the practice of emergency medicine but examples of effective forms of feedback have not been well characterized in the literature. We describe one system of emergency department (ED) outcome feedback called the return visit report (RVR) and present the results of a survey assessing physicians' perceptions of this novel form of feedback. @*METHODS@# An Opinio web-based survey was conducted in 81 emergency physicians (EPs) at three EDs.@*RESULTS@# Of the 81 physicians surveyed, 40 (49%) responded. Most participants indicated that they frequently review their RVRs (83%), that RVRs are valuable to their practice of medicine (80%), and that RVRs alter their practice in future encounters (57%). Respondents reported seeking other forms of outcome feedback including speaking with other EPs (83%) and reviewing discharge summaries of admitted patients (87%). There was no correlation between demographic data and use of RVRs.@*CONCLUSION@# EPs value RVRs as a form of feedback. RVRs could be improved by reducing the observational interval and optimizing report relevance and differential weighting.
ABSTRACT
Background Each year, 2.6 million babies are stillborn worldwide, almost all in low- and middleincome countries. Several global initiatives, including the Sustainable Development Goals and theEvery Newborn Action Plan, have contributed to a renewed focus on prevention of stillbirths. Despitebeing relatively wealthy, the state of Haryana in India has a significant stillbirth rate. This qualitativestudy explored the factors that might contribute to these stillbirths.Methods This was a sub-study of a case–control study of factors associated with stillbirth in 15 of the21 districts of Haryana in 2014–2015. A total of 43 in-depth interviews were conducted with motherswho had recently experienced a stillbirth, or with a family member. By use of reflexive and inductivequalitative methodology, the data set was coded to allow categories to emerge.Results Two categories and several subcategories were identified. First, factors occurring before thewoman reached a health-care facility were: lack of awareness of the mothers and family members;intake of sex-selection drugs during pregnancy, in order to have a male child; non-adherence totreatment for high blood pressure; lack of prior identification of an appropriate health-care facilityfor delivery; and transportation to a health-care facility for delivery. Second, factors occurring oncethe health-care facility was reached were: lack of timely and adequate management; and use ofmedication during labour.Conclusion Intrapartum stillbirths are closely linked to the availability and accessibility of appropriatemedical care. Timely and appropriate treatment and care, provided by a trained and skilled healthworker during pregnancy and labour, as well as soon after delivery, is an absolute requirementfor averting these stillbirths. This study underscores the importance of imparting and increasingawareness regarding factors that have a significant bearing on stillbirth and can be mitigated throughprompt and adequate obstetric health-care services.
