Convalescent plasma (CP) therapy in COVID-19 disease may improve clinical outcome in severe disease. This pilot study was undertaken to inform feasibility and safety of further definitive studies. This was a prospective, interventional and randomized open label pilot trial in patients with severe COVID-19. Twenty COVID-19 patients received two 200 ml transfusions of convalescent patient CP over 24-h compared with 20 who received standard of care. The primary outcome was the requirement for ventilation (non-invasive or mechanical ventilation). The secondary outcomes were biochemical parameters and mortality at 28 days. The CP group were a higher risk group with higher ferritin levels (p < 0.05) though respiratory indices did not differ. The primary outcome measure was required in 6 controls and 4 patients on CP (risk ratio 0.67, 95% CI 0.22–2.0, p = 0.72); mean time on ventilation (NIV or MV) did not differ. There were no differences in secondary measures at the end of the study. Two patients died in the control and one patient in the CP arm. There were no significant differences in the primary or secondary outcome measures between CP and standard therapy, although a larger definitive study is needed for confirmation. However, the study did show that CP therapy appears to be safe in hospitalized COVID-19 patients with hypoxia.Clinical trials registration NCT04356534: 22/04/2020.
Background. Convalescent plasma (CP) therapy in COVID-19 disease has been suggested to improve clinical outcome in severe disease. This pilot study was designed to inform the design of a definitive phase 3 clinical trial. Methods. This was a prospective, interventional and randomized open label pilot trial involving 40 patients with COVID-19 who were requiring oxygen therapy and who had radiological evidence of pneumonia. Twenty COVID-19 patients received two 200ml transfusions of convalescent patient CP over 24 hours were compared with 20 patients who received routine care alone. The primary outcome was the requirement for ventilation. The secondary outcomes were white blood cell count, lactate dehydrogenase (LDH), C-reactive protein (CRP), Troponin, Ferritin, D-Dimer, procalcitonin, mortality rate at 28 days. Results. The CP group were a higher risk group with higher ferritin levels (p<0.05) though respiratory indices did not differ. The primary outcome measure (ventilation) was required in 6 controls and 4 patients on CP (risk ratio 0.67 95% CI 0.22 to 2.0, p=0.72); mean time on ventilation was 10.5 days in the control against 8.2 days in patients on CP (p=0.81). There were no differences in secondary measures at the end of the study. Two patients died in the control and one patient in the CP arm. Conclusion. There were no significant differences in the primary or secondary outcome measures between CP and standard therapy though fewer patients required ventilation and for a shorter period of time. The study showed that CP therapy appears to be safe and it is feasible to perform a definitive phase 3 clinical trial using this study protocol.
Highlights 2714 individuals underwent mandatory quarantine. 136 individuals were SARS-CoV-2 positive on arrival of whom the majority (92) were asymptomatic. A further 52 individuals became SARS-CoV-2 positive over a 14 day period. 24 subjects found to be SARS-CoV-2 positive at day 14 remained asymptomatic until viral clearance. Asymptomatic patients with COVID-19 were more prevalent than those exhibiting symptoms and are an infection reservoir.
Highlights Sickle cell disease results from a mutation in the hemoglobin beta chain. SARS-CoV-2 may decrease the heme oxygen-carrying capacity. Reduced oxygen carrying capacity may lead to sickle cell crisis. No increased disease severity was seen in Covid-19-infected sickle cell patients. No patient underwent a sickle cell crisis with concurrent SARS-Cov-2 infection. SARS-Cov-2 clearance rate did not differ between those with and without sickle cell disease.
Purpose End-stage renal disease patients have a high mortality rate linked to cardiovascular complications, and one of these complications is vascular calcification. This study was performed to test if presepsin, an inflammatory marker, is a predictor of coronary artery calcification (CAC) in hemodialysis (HD) patients. Patients and Methods This study was a cross-sectional design involving 48 HD patients and 13 control subjects. Coronary artery calcification score (CACs) was evaluated by a high resolution, ECG synchronized computed tomography of the heart using a CT calcium scoring. Presepsin and other laboratory analyses were performed on blood samples drawn before HD. Results Presepsin levels in HD patients were 14 times higher than healthy controls (P<0.01). Also, all laboratory tests except for vitamin D were significantly different than controls. Presepsin, phosphorus levels, and calcium-phosphate product were positively correlated with increasing CACs within groups of zero to moderate calcifications (p<0.05, R=0.459 and <0.01, R=0.591, respectively). These correlations were not seen with eGFR, PTH, calcium, vitamin D, CRP, or ESR levels. Furthermore, the log-transformed data of presepsin correlated with 1–15 months of HD vintage (p<0.05, R=0.482), whereas CACs data correlated with 1–20 months of HD vintage (p<0.05, R=0.425). Conclusion Although this study is preliminary and has a limited number of patients, it shows that presepsin, as an inflammatory marker, correlates with the development of moderate CAC in HD patients and may predict CAC development. Therefore, measuring presepsin and managing inflammation before and during the early phases of HD may lower coronary calcification development. However, more clinical studies in this direction are essential.
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