Objectives: Convalescent 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.
Design: Open-label, parallel-arm, phase II, multicentre, randomized controlled trial.
Setting: Thirty-nine public and private hospitals across India.
Participants: Hospitalized, moderately ill confirmed COVID-19 patients (PaO2/FiO2: 200-300 or respiratory rate > 24/min and SpO2 ≤ 93% on room air).
Intervention: Participants 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 Measure: Composite of progression to severe disease (PaO2/FiO2<100) or all-cause mortality at 28 days post-enrolment.
Results: Between 22 nd April to 14 th 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].
Interpretation: CP 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.
Osteoporosis is common disorder of elderly population all over the world as well as in India. The presence of osteoporosis predicts fracture risk. Fragility fracture has marked morbidity as well as mortality. Thus, osteoporosis has marked therapeutic and economic implications. Osteoporosis is defined by low bone mineral density (BMD). The gold-standard method to assess BMD is dual X-ray absorptiometry (DXA). In India, hologic and lunar machines are most commonly used to measure BMD; these machines have their own normative data from which patients BMD is compared and results are generated. As per recommendations, all postmenopausal women and men above 70 years need BMD estimation other than quite a few other specific indications as well. With increasing life expectancy, increased awareness of osteoporosis, and availability of DXA machines, there is flooding of requests for BMD estimation. In view of all this, it becomes imperative on part of physicians, orthopedicians, rheumatologists, and endocrinologists alike to be fully aware about pitfalls in BMD assessment by DXA and interpretation of BMD reports.
The present cross-sectional study was conducted to determine the vitamin D status of pregnant Indian women and their breast-fed infants. Subjects were recruited from the Department of Obstetrics, Armed Forces Clinic and Army Hospital (Research and Referral), Delhi. A total of 541 apparently healthy women with uncomplicated, single, intra-uterine gestation reporting in any trimester were consecutively recruited. Of these 541 women, 299 (first trimester, ninety-seven; second trimester, 125; third trimester, seventy-seven) were recruited in summer (April -October) and 242 (first trimester, fifty-nine, second trimester, ninety-three; third trimester, ninety) were recruited in winter (November -March) to study seasonal variations in vitamin D status. Clinical, dietary, biochemical and hormonal evaluations for the Ca -vitamin D-parathormone axis were performed. A subset of 342 mother -infant pairs was re-evaluated 6 weeks postpartum. Mean serum 25-hydroxyvitamin D (25(OH)D) of pregnant women was 23·2 (SD 12·2) nmol/l. Hypovitaminosis D (25(OH)D ,50 nmol/l) was observed in 96·3 % of the subjects. Serum 25(OH)D levels were significantly lower in winter in the second and third trimesters, while serum intact parathormone (iPTH) and alkaline phosphatase levels were significantly higher in winter in all three trimesters. A significant negative correlation was found between serum 25(OH)D and iPTH in mothers (r 20·367, P¼0·0001) and infants (r 2 0·56, P¼ 0·0001). A strong positive correlation was observed between 25(OH)D levels of mother -infant pairs (r 0·779, P¼ 0·0001). A high prevalence of hypovitaminosis D was observed in pregnancy, lactation and infancy with no significant inter-trimester differences in serum 25(OH)D levels.
A high prevalence of osteoporosis was observed in elderly Indian subjects. pDXA has high negative predictive value, making it a useful tool in population screening for osteoporosis.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.