There is a need for effective therapy for COVID-19 pneumonia. Convalescent plasma has antiviral activity and early observational studies suggested benefit in reducing COVID-19 severity. We investigated the safety and efficacy of convalescent plasma in hospitalized patients with COVID-19 in a population with a high HIV prevalence and where few therapeutic options were available. We performed a double-blinded, multicenter, randomized controlled trial in one private and three public sector hospitals in South Africa. Adult participants with COVID-19 pneumonia requiring non-invasive oxygen were randomized 1:1 to receive a single transfusion of 200 mL of either convalescent plasma or 0.9% saline solution. The primary outcome measure was hospital discharge and/or improvement of ≥ 2 points on the World Health Organisation Blueprint Ordinal Scale for Clinical Improvement by day 28 of enrolment. The trial was stopped early for futility by the Data and Safety Monitoring Board. 103 participants, including 21 HIV positive individuals, were randomized at the time of premature trial termination: 52 in the convalescent plasma and 51 in the placebo group. The primary outcome occurred in 31 participants in the convalescent plasma group and and 32 participants in the placebo group (relative risk 1.03 (95% CI 0.77 to 1.38). Two grade 1 transfusion-related adverse events occurred. Participants who improved clinically received convalescent plasma with a higher median anti-SARS-CoV-2 neutralizing antibody titre compared with those who did not (298 versus 205 AU/mL). Our study contributes additional evidence for recommendations against the use of convalescent plasma for COVID-19 pneumonia. Safety and feasibility in this population supports future investigation for other indications.
Plasmacytomas are malignant proliferations of plasma cells which can occur with different plasma cell dyscrasias. Solitary plasmacytomas of bone or extraosseous plasmacytomas, depending on the tissue of origin, develop in isolation without systemic manifestations of multiple myeloma. Three cases of cranial plasmacytomas are described, two in patients with multiple myeloma and one extraosseous plasmacytoma. Management options are discussed.
Background: Globally, cleft deformities are the most common craniofacial anomalies and show an association with congenital heart defects. Little research on cleft lips and/or palates (CL/P) and congenital heart defects has been reported from Africa, and none from South Africa. In 2001, it was proposed that CL/P be listed as one of six priority conditions for monitoring and notification to South African health authorities. This goal of creating a national registry has not been achieved. A near-fatal anaesthetic incident following a missed cardiac lesion in a child with a cleft lip and palate prompted this study.
Objectives: To describe the prevalence of congenital heart defects diagnosed in children with CL/P presenting for corrective surgery during the Smile Week over three consecutive years (2013–2015) at an academic hospital in South Africa.
Methods: A retrospective, descriptive file review of 62 patients with CL/P was performed. Since 2013, echocardiography has been performed on all patients with CL/P.
Results: Twenty-three, 21 and 18 patients were operated in 2013, 2014 and 2015, respectively. Of these patients, 85.5% (n = 53) had no clinical evidence of a cardiac defect, of which eight did have clinically significant cardiac defects on echocardiography. Sixteen patients (25.8%) in total (n = 16/62) with a cleft deformity had a clinically significant congenital heart lesion. Of the 16 patients with a cardiac defect on transthoracic echocardiography, only four had clinical evidence of cardiac defect. Therefore, sensitivity of clinical examination was 25%, whereas the specificity was 89.1%. Three of the four patients with a syndrome had a clinically significant echocardiographic finding.
Conclusion: A national guideline for the preoperative care of patients with CL/P, including routine echocardiography, is needed. Furthermore, a national registry is required for patients with CL/P with associated congenital anomalies.
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