BACKGROUNDPassive immunotherapy with convalescent plasma (CP) is a potential treatment for COVID-19. Evidence from controlled clinical trials is inconclusive.METHODSWe conducted a randomized, ...open-label, controlled clinical trial at 27 hospitals in Spain. Patients had to be admitted for COVID-19 pneumonia within 7 days from symptom onset and not on mechanical ventilation or high-flow oxygen devices. Patients were randomized 1:1 to treatment with CP in addition to standard of care (SOC) or to the control arm receiving only SOC. The primary endpoint was the proportion of patients in categories 5 (noninvasive ventilation or high-flow oxygen), 6 (invasive mechanical ventilation or extracorporeal membrane oxygenation ECMO), or 7 (death) at 14 days. Primary analysis was performed in the intention-to-treat population.RESULTSBetween April 4, 2020, and February 5, 2021, 350 patients were randomly assigned to either CP (n = 179) or SOC (n = 171). At 14 days, proportion of patients in categories 5, 6, or 7 was 11.7% in the CP group versus 16.4% in the control group (P = 0.205). The difference was greater at 28 days, with 8.4% of patients in categories 5-7 in the CP group versus 17.0% in the control group (P = 0.021). The difference in overall survival did not reach statistical significance (HR 0.46, 95% CI 0.19-1.14, log-rank P = 0.087).CONCLUSIONCP showed a significant benefit in preventing progression to noninvasive ventilation or high-flow oxygen, invasive mechanical ventilation or ECMO, or death at 28 days. The effect on the predefined primary endpoint at 14 days and the effect on overall survival were not statistically significant.TRIAL REGISTRATIONClinicaltrials.gov, NCT04345523.FUNDINGGovernment of Spain, Instituto de Salud Carlos III.
BackgroundVaccine effectiveness (VE) is essential to monitor the performance of vaccines and generate strategic information to guide decision making. We pooled data from six Latin American countries ...to estimate the effectiveness of COVID-19 vaccines in preventing laboratory-confirmed SARS-CoV-2 hospitalisation during three different pandemic waves from February 2021 to September 2022.MethodsWe used a test-negative case-control design in hospitalised adults in Chile, Costa Rica, Ecuador, Guatemala, Paraguay, and Uruguay. We estimated adjusted VE by age group (18-64 and ≥65 years), vaccine type and product for primary series vaccination and booster vaccination and by time since last dose during the Omicron variant dominant period. We used mixed effects logistic regression models adjusting for sex, age, week of onset of symptom onset and pre-existing conditions with country fit as a random effect term.FindingsWe included 15,241 severe acute respiratory infection (SARI) patients in the analysis. Among adults 18-64 years, VE estimates for primary series vaccination during pre-Delta and Delta periods ranged by product from 66.5% to 95.1% and from 33.5% to 88.2% for older adults. During the Omicron period, VE estimates for primary series were lower and decreased by time since last vaccination, but VE increased to between 26.4% and 57.4% when a booster was administered.InterpretationmRNA and viral vector vaccines presented higher VE for both primary series and booster. While VE decreased over time, protection against severe COVID-19-associated hospitalisation increased when booster doses were administered. Vaccination with additional doses should be recommended, particularly for persons at increased risk of developing severe COVID-19.FundingThis work was supported by a grant from the U.S. Centers for Disease Control and Prevention (CDC) through cooperative agreements with the Pan American Health Organization/World Health Organization.
Background: Vaccine effectiveness (VE) is essential to monitor the performance of vaccines and generate strategic information to guide decision making. We pooled data from six Latin American ...countries to estimate the effectiveness of COVID-19 vaccines in preventing laboratory-confirmed SARS-CoV-2 hospitalisation during three different pandemic waves from February 2021 to September 2022. Methods: We used a test-negative case-control design in hospitalised adults in Chile, Costa Rica, Ecuador, Guatemala, Paraguay, and Uruguay. We estimated adjusted VE by age group (18–64 and ≥65 years), vaccine type and product for primary series vaccination and booster vaccination and by time since last dose during the Omicron variant dominant period. We used mixed effects logistic regression models adjusting for sex, age, week of onset of symptom onset and pre-existing conditions with country fit as a random effect term. Findings: We included 15,241 severe acute respiratory infection (SARI) patients in the analysis. Among adults 18–64 years, VE estimates for primary series vaccination during pre-Delta and Delta periods ranged by product from 66.5% to 95.1% and from 33.5% to 88.2% for older adults. During the Omicron period, VE estimates for primary series were lower and decreased by time since last vaccination, but VE increased to between 26.4% and 57.4% when a booster was administered. Interpretation: mRNA and viral vector vaccines presented higher VE for both primary series and booster. While VE decreased over time, protection against severe COVID-19-associated hospitalisation increased when booster doses were administered. Vaccination with additional doses should be recommended, particularly for persons at increased risk of developing severe COVID-19. Funding: This work was supported by a grant from the U.S. Centers for Disease Control and Prevention (CDC) through cooperative agreements with the Pan American Health Organization/World Health Organization.
La cirugía cardiovascular es la especialidad médica que se ocupa de la prevención, diagnóstico y tratamiento quirúrgico de los trastornos y enfermedades del sistema cardiocirculatorio. Los continuos ...y rápidos avances en el diagnóstico y tratamiento de las enfermedades cardiovasculares justifican la necesidad de llevar a cabo una actualización de los principales aspectos definitorios y organizativos de la especialidad, relacionados con la profesión (de la práctica, calidad asistencial), con el programa docente de la especialidad, la formación continuada de los cirujanos, los procesos de acreditación desde la Sociedad Española de Cirugía Torácica-Cardiovascular, entre otros.
Este documento, elaborado por expertos de la cirugía cardiovascular, representa la opinión de la Sociedad Española de Cirugía Torácica-Cardiovascular y actualiza los principales aspectos de la especialidad en nuestro país.
Cardiovascular surgery is the medical specialty that deals with the prevention, diagnosis, and surgical treatment of disorders and diseases of the circulatory system. The continuous and rapid advances in the diagnosis and treatment of cardiovascular diseases justify the need to update the main, defining, and organisational aspects of the specialty, related to the profession (its practice, quality care), aspects on the teaching program of the specialty, the continuing education program of the surgeons, the processes of accreditation from the Spanish Society of Thoracic-Cardiovascular Surgery, etc.
This document, prepared by experts in cardiovascular surgery, represents the opinion of the Spanish Society of Thoracic-Cardiovascular surgery and updates the main aspects of the specialty in our country.
—Un paciente varón de 18 años de edad, con antecedentes de agammaglobulinemia ligada al cromosoma X o de Bruton, presentó simultáneamente lesiones atípicas de celulitis, en ambas piernas y brazo ...izquierdo, y bacteriemia por Campylobacter jejuni, sin sintomatología intestinal previa. Tanto C. jejuni como los bacilos del género Helicobacter o Flexispira deben ser considerados causa de septicemias/bacteriemias, celulitis, abscesos, uveítis, artritis y osteomielitis en pacientes con cualquier tipo de inmunodeficiencia, incluida la agammaglobulinemia ligada al X.
—A 15-year-old male patient, with a history of X-linked or Bruton's agammaglobulinemia, presented simultaneously with atypical cellulitis lesions, in both legs and the right arm, and bacteremia from Campylobacter jejuni, with no prior intestinal symptoms. Both C. jejuni and bacilli of the genus Helicobacter or Flexispira must be considered a cause of septicemias/bacteremias, cellulitis, abscesses, uveitis, arthritis and osteomyelitis in patients with any type of immunodeficiency, including X-linked agammaglobulinemia.