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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.
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OBJECTIVE: To study the prevalence, clinical features, electrophysiological features and severity of peripheral neuropathy in chronic kidney disease (CKD) patients. METHODS: Between May 2015 and December 2016, 200 CKD patients and 25 controls were assessed prospectively. RESULTS: Prevalence of peripheral neuropathy in CKD patients was 50% based on clinical symptoms and 89% based on electrophysiological studies. Mean age of 200 CKD patients was 54.1 ± 11.9 years. 135 (67.5%) were male and 65 (32.5%) were female. Mean duration of disease was 4.2 ± 3.7 years. Positive sensory, negative sensory and autonomic symptoms were seen in 97(48.5%), 77(38.5%) and 17(8.5%) patients respectively. Symptomatic neuropathy was common in peritoneal dialysis patients. Definite and early damage was seen in 133 (66.5%) and 45 patients (22.5%) respectively, while 22 patients (11%) had no significant peripheral neuropathy. In predialysis patients (n=100); 63 (63%) had definite damage and 24(24%) had early damage. In peritoneal dialysis patients (n=50); 34(68%) had definite damage and 8(16%) had early damage. In hemodialysis patients (n=50); 36(72%) had definite damage and 13(26%) had early damage. Hemodialysis group (98%) showed more severe peripheral neuropathy. Most common nerves involved were sural, ulnar sensory, median sensory, common peroneal and posterioir tibial in CKD. Axonal and mixed sensorimotor neuropathy patterns were most common patterns in CKD. CONCLUSION: Peripheral neuropathy is common in CKD with highest prevalence and severity in hemodialysis group. Symptomatic peripheral neuropathy is common in peritoneal dialysis group. Newer treatment modalities are required to manage uremic neuropathy in early stage.