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.
Background Diabetes mellitus may be associated with increased severity and enhanced mortality in COVID-19 infections. The present study was undertaken to evaluate the clinical presentation, laboratory parameters, radiological imaging, management, and outcome of COVID-19 infection in patients of diabetes mellitus and its association with glycemic control. Methods The present study was designed to evaluate the difference between uncontrolled and controlled diabetes for COVID-19 manifestations by enrolling 80 admitted COVID-19 patients. Patients were categorized into two groups, where group 1 had patients with uncontrolled diabetes as indicated by HbA1c > 8 g% and group 2 had patients with controlled diabetes as indicated by HbA1c < 8 g%. Information concerning medical history, clinical manifestations, laboratory findings, radiological imaging, management, and outcome was extracted from medical records for evaluation, interpretation, and association among both the groups. Results COVID-19 patients with uncontrolled diabetes exhibited a severe symptomatic presentation, excessive uncontrolled inflammatory responses, and hypercoagulable state. Total leukocyte count, neutrophil-lymphocyte ratio, serum levels of IL-6, FDP, and Ddimer were significantly raised (p < 0.05) in case of uncontrolled diabetes as compared with controlled diabetes. Radiological findings detected by chest radiograph and computed tomography chest suggested severe lung involvement in uncontrolled diabetes. COVID-19 patients with uncontrolled diabetes required intensive treatment as compared with controlled diabetes group in terms of insulin therapy (p = 0.0226) and non-invasive ventilation (p = 0.0292). Patients with uncontrolled diabetes had higher mortality (p = 0.0375) and required prolonged hospitalization (p = 0.0479) as compared with controlled diabetes group. Conclusion From the current study, it can be concluded that uncontrolled diabetic condition might be a risk factor for severity and morbidity of COVID-19 patients. Uncontrolled diabetes mellitus might be responsible for an overall higher susceptibility for COVID-19 infection and severity in terms of symptomatic presentation, inflammatory storm, rapid pulmonary invasion, requirement of more intensive treatment, and a poor outcome.
Diaphragmatic injury is a rare entity and clinically difficult to be diagnosed as symptoms are often masked due to associated injury in a poly trauma case. There are no specific signs and symptoms for diagnosing diaphragmatic rupture. High degree of clinical suspicion is needed in all cases of thoraco-abdominal injury to diagnose a case of diaphragmatic rupture. Computed Tomography (CT) chest and abdomen is very useful in diagnosis. When in doubt a diagnostic laparoscopy should be undertaken to establish a diagnosis to reduce mortality and morbidity.
Objective: Preparation of Rosuvastatin Calcium by Using Hydrophilic Polymers and Solid Dispersion Method, Rosuvastatin calcium is a Dyslipidaemic agent, which act as a selective competitive inhibitor of HMG CoA educates enzyme and is used in the treatment of hyperlipidemia.
Methods: In the present work, Solid Dispersion was prepared by kneading method to increase the solubility of Rosuvastatin Calcium.
Results: Solid dispersions were evaluated by determining percentage yield, drug content, solubility, Scanning electron microscopy (SEM), powder X-ray diffraction (PXRD), DSC and in vitro dissolution profile. The prepared solid dispersion are formulated into capsule dosage form and characterized by various parameters i.e. weight variation, content uniformity, disintegration and dissolution. The evaluated parameters of capsule dosage form increase in solubility and dissolution rate of the pure drug.
Conclusion: These are various techniques to enhance the solubility of the drug, such as particle size reduction, use of surfactants, solid dispersion etc. Carriers are the major players in these formulations, e. g. Hydroxypropylmethylcellulose, ethylcellulose, Carbopol, Acacia Gum etc. Carbopol and Acacia Gum is one of the most efficient polymers work as a carrier for these drugs to enhance solubility.
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