Three-Day Icatibant on Top of Standard Care in Patients With Coronavirus Disease 2019 Pneumonia: A Randomized, Open-Label, Phase 2, Proof-of-Concept Trial.

BACKGROUND: We aimed to evaluate icatibant, a competitive antagonist of the bradykinin B2 receptors, for the treatment of inpatients with coronavirus disease 2019 (COVID-19) pneumonia admitted in the early hypoxemic stage. METHODS: The randomized, open-label clinical trial of icatibant for COVID-19 pneumonia (ICAT·COVID, registered as NCT04978051 at ClinicalTrials.gov) was conducted in Barcelona. Inpatients requiring supplemental but not high-flow oxygen or mechanical ventilation were allocated (1:1) to treatment with either three 30-mg icatibant doses/d for 3 consecutive days plus standard care or standard care alone, and followed for up to 28 days after initial discharge. The primary and key secondary outcomes were clinical response on study day 10/discharge and clinical efficacy at 28 days from initial discharge, respectively. RESULTS: Clinical response occurred in 27 of 37 patients (73.0%) in the icatibant group and 20 of 36 patients (55.6%) in the control group (rate difference, 17.42; 95% confidence interval [CI], -4.22 to 39.06; P = .115). Clinical efficacy ensued in 37 patients (100.0%) in the icatibant group and 30 patients (83.3%) in the control group (rate difference, 16.67; 95% CI, 4.49-28.84; P = .011). No patient died in the icatibant group, compared with 6 patients (16.7%) in the control group (P = .011). All patients but 1 had adverse events, which were evenly distributed between study arms. No patient withdrew because of adverse events. CONCLUSIONS: Adding icatibant to standard care was safe and improved both COVID-19 pneumonia and mortality in this proof-of-concept study. A larger, phase 3 trial is warranted to establish the clinical value of this treatment. CLINICAL TRIALS REGISTRATION: NCT04978051.

[Revisit after discharge from the emergency department in a cohort of patients with COVID-19 pneumonia and analysis based on the healthcare resource used for follow-up. RESALSEVID study]. / Análisis de la evolucion tras el alta de urgencias en pacientes con neumonía por COVID-19 en función del recurso sanitario utilizado para el seguimiento: estudio RESALSEVID.

INTRODUCTION: COVID-19 pneumonia is a manifestation of SARS-CoV-2 infection and in most cases involves hospital admission. There are recommendations according to which these patients can be discharged without hospital admission, but there is no evidence regarding the revisit and the most appropriate type of follow-up. The objective of the RESALSEVID study was to investigate the variables associated with the 30-day revisit (Rev30d) in a group of patients discharged directly from 4 emergency departments (ED) with COVID-19 pneumonia, and analyze whether there were differences based on 4 different tracking devices. METHOD: Analysis of a prospective cohort of patients discharged directly from the ED with COVID-19 pneumonia in 4 hospital with different models of follow-up at discharge (primary care, hospitalization at home [HaH] phone and in person, HaH phone, hospital phone). RESULTS: Five hundred twenty patients were included, with a mean age of 50.1 years and 51% men. Rev30d was 18.3% and was related only to immunosuppression, odds ratio 4.49 (95% confidence interval 1.10-18.24); p=0.022. There was no difference in Rev30d based on the follow-up model used at discharge from the ED. CONCLUSIONS: There are some recommendations that allow the safe discharge of patients with COVID-19 pneumonia, with no differences in Rev30d depending on the type of follow-up.

Sociodemographic characteristics, comorbidity, and baseline functional status of older patients treated in emergency departments during the COVID-19 pandemic and associations with mortality: an analysis based on the EDENCOVID cohort. / Sociodemografía, comorbilidad y situación funcional basal de los pacientes mayores atendidos en urgencias durante la pandemia de COVID y su relación con la mortalidad: análisis a partir de la cohorte EDEN-Covid.

OBJECTIVES: To describe the sociodemographic characteristics, comorbidity, and baseline functional status of patients aged 65 or older who came to hospital emergency departments (EDs) during the first wave of the COVID-19 pandemic, and to compare them with the findings for an earlier period to analyze factors of the index episode that were related to mortality. MATERIAL AND METHODS: We studied data from the EDEN-COVID cohort (Emergency Department and Elder Needs During COVID-19) of patients aged 65 years or older treated in 40 Spanish EDs on 7 consecutive days. Nine sociodemographic variables, 18 comorbidities, and 7 function variables were registered and compared with the findings for the EDEN cohort of patients included with the same criteria and treated a year earlier in the same EDs. In-hospital mortality was calculated in the 2 cohorts and a multivariable logistic regression model was used to explore associated factors. RESULTS: The EDEN-COVID cohort included 6806 patients with a median age of 78 years; 49% were women. The pandemic cohort had a higher proportion of men, patients covered by the national health care system, patients brought from residential facilities, and patients who arrived in an ambulance equipped for advanced life support. Pandemic-cohort patients more often had diabetes mellitus, chronic kidney disease, and dementia; they less often had connective tissue and thromboembolic diseases. The Barthel and Charlson indices were worse in this period, and cognitive decline was more common. Fewer patients had a history of depression or falls. Eight hundred ninety these patients (13.1%) died, 122 of them in the ED (1.8%); these percentages were lower in the earlier EDEN cohort, at 3.1% and 0.5%, respectively. Independent sociodemographic factors associated with higher mortality were transport by ambulance, older age, male sex, and living in a residential facility. Mortalityassociated comorbidities were neoplasms, chronic kidney disease, and heart failure. The only function variable associated with mortality was the inability to walk independently. A history of falls in the past 6 months was a protective factor. CONCLUSION: The sociodemographic characteristics, comorbidity, and functional status of patients aged 65 years or older who were treated in hospital EDs during the pandemic differed in many ways from those usually seen in this older-age population. Mortality was higher than in the prepandemic period. Certain sociodemographic, comorbidity, and function variables were associated with in-hospital mortality.

OBJETIVO: Investigar sociodemografía, comorbilidad y situación funcional de los pacientes de 65 o más años de edad que consultaron a los servicios de urgencias hospitalarios (SUH) durante la primera oleada epidémica de COVID, compararlas con un periodo previo y ver su relación. METODO: Se utilizaron los datos obtenidos de la cohorte EDEN-Covid (Emergency Department and Elder Needs during COVID) en la que participaron 40 SUH españoles que incluyeron todos los pacientes de $ 65 años atendidos durante 7 días consecutivos. Se analizaron 9 características sociodemográficas, 18 comorbilidades y 7 variables de funcionalidad, que se compararon con las de la cohorte EDEN (Emergency Department and Elder Needs), que contiene pacientes con el mismo criterio de inclusión etario reclutados por los mismos SUH un año antes. Se recogió la mortalidad intrahospitalaria y se investigaron los factores asociados mediante regresión logística multivariable. RESULTADOS: La cohorte EDEN-Covid incluyó 6.806 pacientes (mediana edad: 78 años; 49% mujeres). Hubo más varones, con cobertura sanitaria pública, procedentes de residencia y que llegaron con ambulancia medicalizada que durante el periodo prepandemia. Presentaron más frecuentemente diabetes mellitus, enfermedad renal crónica, enfermedad cerebrovascular y demencia y menos conectivopatías y enfermedad tromboembólica, peores índices de Barthel y Charlson, más deterioro cognitivo y menos antecedentes de depresión o caídas previas. Fallecieron durante el episodio 890 pacientes (13,1%), 122 de ellos en urgencias (1,8%), porcentajes superiores al periodo prepandemia (3,1% y 0,5%, respectivamente). Se asociaron de forma independiente a mayor mortalidad durante el periodo COVID la llegada en ambulancia, mayor edad, ser varón y vivir en residencia como variables sociodemográficas, y neoplasia, enfermedad renal crónica e insuficiencia cardiaca como comorbilidades. La única variable funcional asociada a mortalidad fue no deambular respecto a ser autónomo, y la existencia de caídas los 6 meses previos resultó un factor protector. CONCLUSIONES: La sociodemografía, comorbilidad y funcionalidad de los pacientes de 65 o más años que consultaron en los SUH españoles durante la primera ola pandémica difirieron en muchos aspectos de lo habitualmente observado en esta población. La mortalidad fue mayor a la del periodo prepandémico. Algunos aspectos sociodemográficos, de comorbilidad y funcionales se relacionaron con la mortalidad intrahospitalaria.

Sociodemografía, comorbilidad y situación funcional basal de los pacientes mayores atendidos en urgencias durante la pandemia de COVID y su relación con la mortalidad: análisis a partir de la cohorte EDEN-Covid

Objective. To describe the sociodemographic characteristics, comorbidity, and baseline functional status of patients aged 65 or older who came to hospital emergency departments (EDs) during the first wave of the COVID-19 pandemic, and to compare them with the findings for an earlier period to analyze factors of the index episode that were related to mortality. Methods. We studied data from the EDEN-COVID cohort (Emergency Department and Elder Needs During COVID-19) of patients aged 65 years or older treated in 40 Spanish EDs on 7 consecutive days. Nine sociodemographic variables, 18 comorbidities, and 7 function variables were registered and compared with the findings for the EDEN cohort of patients included with the same criteria and treated a year earlier in the same EDs . In-hospital mortality was calculated in the 2 cohorts and a multivariable logistic regression model was used to explore associated factors. Results. The EDEN-COVID cohort included 6806 patients with a median age of 78 years;49% were women. The pandemic cohort had a higher proportion of men, patients covered by the national health care system, patients brought from residential facilities, and patients who arrived in an ambulance equipped for advanced life support. Pandemic-cohort patients more often had diabetes mellitus, chronic kidney disease, and dementia;they less often had connective tissue and thromboembolic diseases. The Barthel and Charlson indices were worse in this period, and cognitive decline was more common. Fewer patients had a history of depression or falls. Eight hundred ninety these patients (13.1%) died, 122 of them in the ED (1.8%);these percentages were lower in the earlier EDEN cohort, at 3.1% and 0.5%, respectively. Independent sociodemographic factors associated with higher mortality were transport by ambulance, older age, male sex, and living in a residential facility. Mortality- associated comorbidities were neoplasms, chronic kidney disease, and heart failure. The only function variable associated with mortality was the inability to walk independently. A history of falls in the past 6 months was a protective factor. Conclusions. The sociodemographic characteristics, comorbidity, and functional status of patients aged 65 years or older who were treated in hospital EDs during the pandemic differed in many ways from those usually seen in this older-age population. Mortality was higher than in the prepandemic period. Certain sociodemographic, comorbidity, and function variables were associated with in-hospital mortality.

Análisis de la evolucion tras el alta de urgencias en pacientes con neumonía por COVID19 en función del recurso sanitario utilizado para el seguimiento: Estudio RESALSEVID Revisit after discharge from the emergency department in a cohort of patients with COVID19 pneumonia and analysis based on the healthcare resource used for follow-up. RESALSEVID study

Introducción: la neumonía COVID19 es una manifestación de la infección por SARS-CoV-2 y en la mayoría de casos supone ingreso hospitalario. Existen recomendaciones según las cuales se puede dar de alta a estos pacientes sin precisar ingreso hospitalario, pero no hay evidencia en relación a la revisita y el tipo de seguimiento más adecuado. El objetivo del estudio RESALSEVID fue investigar las variables asociadas a la revisita a los 30 días (Rev30d) en un grupo de pacientes dados de alta directamente en 4 servicios de urgencias hospitalarios (SUH) con neumonía COVID19, y analizar si existieron diferencias en función de 4 dispositivos de seguimiento diferentes. Método: análisis de una cohorte prospectiva de pacientes dados de alta directamente desde urgencias con neumonía COVID19 en 4 SUH con diferentes modelos de seguimiento al alta (atención primaria, hospitalización a domicilio [HaD] telefónico y presencial, HaD telefónico, telefónico hospitalario). Resultados: se incluyeron 520 pacientes, con una media de edad de 50,1 años y 51% varones. La Rev30d fue del 18,3% y se relacionó únicamente con la inmunosupresión, odds ratio 4,49 (intervalo de confianza del 95% 1,10 – 18,24);p=0,022. No hubo ninguna diferencia en la Rev30d en función del modelo de seguimiento utilizado al alta de urgencias. Conclusiones: existen una serie de recomendaciones que permiten dar de alta de manera segura a pacientes con neumonía COVID19, no existiendo diferencias en la Rev30d en función del tipo de seguimiento.

The COVID-19 vaccination acceptance/hesitancy rate and its determinants among healthcare workers of 91 Countries: A multicenter cross-sectional study.

The aim of this study was to investigate the COVID-19 vaccination acceptance rate and its determinants among healthcare workers in a multicenter study. This was a cross-sectional multi-center survey conducted from February 5 to April 29, 2021. The questionnaire consisted of 26 items in 6 subscales. The English version of the questionnaire was translated into seven languages and distributed through Google Forms using snowball sampling; a colleague in each country was responsible for the forward and backward translation, and also the distribution of the questionnaire. A forward stepwise logistic regression was utilized to explore the variables and questionnaire factors tied to the intention to COVID-19 vaccination. 4630 participants from 91 countries completed the questionnaire. According to the United Nations Development Program 2020, 43.6 % of participants were from low Human Development Index (HDI) regions, 48.3 % high and very high, and 8.1 % from medium. The overall vaccination hesitancy rate was 37 %. Three out of six factors of the questionnaire were significantly related to intention to the vaccination. While 'Perceived benefits of the COVID-19 vaccination' (OR: 3.82, p-value<0.001) and 'Prosocial norms' (OR: 5.18, p-value<0.001) were associated with vaccination acceptance, 'The vaccine safety/cost concerns' with OR: 3.52, p-value<0.001 was tied to vaccination hesitancy. Medical doctors and pharmacists were more willing to take the vaccine in comparison to others. Importantly, HDI with OR: 12.28, 95 % CI: 6.10-24.72 was a strong positive determinant of COVID-19 vaccination acceptance. This study highlighted the vaccination hesitancy rate of 37 % in our sample among HCWs. Increasing awareness regarding vaccination benefits, confronting the misinformation, and strengthening the prosocial norms would be the primary domains for maximizing the vaccination coverage. The study also showed that the HDI is strongly associated with the vaccination acceptance/hesitancy, in a way that those living in low HDI contexts are more hesitant to receive the vaccine.

Predictores de revisita en pacientes con infección aguda COVID-19 con seguimiento al año: estudio de cohorte HUBCOVID365

Objective. To analyze the frequencies of 3 types of hospital revisits by patients after treatment for COVID-19 in the emergency department. Methods. Retrospective observational study of consecutive patients who came to the emergency department in March and April 2020 and were discharged alive with a diagnosis of COVID-19. Baseline and acute episode data were collected and the patients were followed for 1 year. We analyzed variables associated with revisits for any reason, revisits related to COVID-19, and early COVID-19-related revisits (within 30 days). Results. A total of 1352 patients with a mean age of 62.1 years (52.9% male) were studied. A total of 553 revisits were made by 342 patients (25.3%) for any reason;132 (9.8%) revisited in relation to COVID-19 at least once. Of those, 103 (7.6%) revisited within 30 days (early) and 29 (2.2%) came later. COVID-19-related revisits were associated with thrombotic events (odds ratio [OR], 7.58;95% CI, 1.75-32.81) and pulmonary fibrosis (OR, 4.95;95% CI, 1.27-19.24);early revisits were inversely associated with follow-up management by a contracted health care support service (OR, 0.18;95% CI, 0.03-0.92). Hospital admission during the initial visit was significantly associated with fewer revisits for any reason or related to COVID-19 at any time. Conclusions. Fewer than half the total number of emergency department revisits after initial care for COVID-19 were related to the novel coronavirus infection. Revisits occurred more often in the first 30 days after discharge. Later COVID-19-related revisits were uncommon, but given the large number of patients with this infection, such visits can be expected. Objetivo. Analizar diferentes categorías de revisita (RV) al año en pacientes con infección COVID-19 que consultan en un servicio de urgencias hospitalario (SUH). Método. Estudio observacional, retrospectivo, que incluyó pacientes consecutivos que consultaron al SUH en los meses de marzo y abril de 2020 con diagnóstico de COVID-19 y fueron dados de alta vivos del hospital. Se recogieron variables basales y del episodio agudo y se realizó un seguimiento al año. Se hicieron tres comparaciones identificando variables asociadas a la RV total, RV relacionada con COVID-19 (RCovid) y RCovid precoz (# 30 días). Resultados. Se analizaron 1.352 pacientes con edad media de 62,1 años y 52,9% varones. En el seguimiento al año hubo 553 RV en 342 (25,3%) pacientes, 132 (9,8%) con al menos una RCovid, 103 (7,6%) precoz y 29 (2,2%) tardía. La RCovid se relacionó con la presencia de fenómenos trombóticos [OR 7,58 (IC 95%: 1,75-32,81)] y la fibrosis pulmonar [OR 4,95 (IC 95%: 1,27-19,24)];y la RCovid precoz se relacionó inversamente con alta a dispositivo de soporte sanitario [OR 0,18 (IC 95%: 0,03-0,92)]. El ingreso hospitalario en el evento índice disminuyó la RV total y RCovid y las hospitalizaciones derivadas de esta RV de manera significativa a largo plazo. Conclusión. Menos de la mitad de la RV total tras una infección COVID-19 está relacionada con la infección, y es más frecuente en los primeros 30 días. La RCovid tardía no es frecuente, pero dado el elevado número de pacientes que han sido infectados por COVID-19 se debe tener en cuenta.