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
Cytomegalovirus (CMV) is a double stranded DNA virus and ubiquitous in nature. Association of Guillain-Barre syndrome (GBS) and CMV is well known but CMV acute myositis is a rare condition. Restriction of movements of limbs due to severe pain in myositis may obscure the diagnosis of GBS and this may easily miss.
Case presentation
Here we describe a 29-year-old male presenting with pain and swelling of bilateral lower limbs which progressed rapidly with increasing serum creatine kinase levels with positive IgM CMV antibodies. In view of no improvement in clinical condition, patient was further evaluated and found to have concurrent GBS. He was treated with plasmapheresis and improved.
Conclusion
Cytomegalovirus infection presenting as acute myositis is a uncommon and further association with GBS is a rare occurrence.
Background Quality indicators in Transfusion Medicine are critically important aspects that can be measured and utilized to design interventions for continuous quality improvement. Interventions for improvement in bedside transfusion practices are required to check the adherence to standard protocol for safe transfusion.
Study design and methodsA prospective study was conducted with a structured checklist survey of 4 key elements, to collect data for baseline assessment phase I survey, subsequently phase II survey repeated after introduction of Transfusion Monitoring Form and Telephonic reminders from blood bank. Pre-and Post-intervention data collected, tabulated and analysed using Statistical Package for Social Sciences (SPSS version 23). Results Identification of Patient, Transfusion initiation within 30 min of issue, Vitals monitoring during transfusion and completion of transfusion within time limit are the four key elements of quality indicators were checked pre-and postintervention. Mean composite score of quality indicators before intervention was 2Á3 AE 1Á3 and increased to 3Á2 AE 1Á3 (P value < 0Á001) after implementation of the Transfusion Monitoring form and Reminder calls from Blood Bank. Conclusion Manufacturing good quality blood components alone does not ensure good transfusion services. Active interventions by Transfusion specialist ensure good bedside transfusion practices. Introduction of blood transfusion monitoring form and Telephonic reminders from the blood centre brought in significant changes in the existing bedside transfusion practices and safer transfusion at our centre.
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