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2.
N Engl J Med ; 2021 Feb 25.
Artículo en Inglés | MEDLINE | ID: covidwho-1101724

RESUMEN

BACKGROUND: Coronavirus disease 2019 (Covid-19) is associated with immune dysregulation and hyperinflammation, including elevated interleukin-6 levels. The use of tocilizumab, a monoclonal antibody against the interleukin-6 receptor, has resulted in better outcomes in patients with severe Covid-19 pneumonia in case reports and retrospective observational cohort studies. Data are needed from randomized, placebo-controlled trials. METHODS: In this phase 3 trial, we randomly assigned patients who were hospitalized with severe Covid-19 pneumonia in a 2:1 ratio receive a single intravenous infusion of tocilizumab (at a dose of 8 mg per kilogram of body weight) or placebo. Approximately one quarter of the participants received a second dose of tocilizumab or placebo 8 to 24 hours after the first dose. The primary outcome was clinical status at day 28 on an ordinal scale ranging from 1 (discharged or ready for discharge) to 7 (death) in the modified intention-to-treat population, which included all the patients who had received at least one dose of tocilizumab or placebo. RESULTS: Of the 452 patients who underwent randomization, 438 (294 in the tocilizumab group and 144 in the placebo group) were included in the primary and secondary analyses. The median value for clinical status on the ordinal scale at day 28 was 1.0 (95% confidence interval [CI], 1.0 to 1.0) in the tocilizumab group and 2.0 (non-ICU hospitalization without supplemental oxygen) (95% CI, 1.0 to 4.0) in the placebo group (between-group difference, -1.0; 95% CI, -2.5 to 0; P = 0.31 by the van Elteren test). In the safety population, serious adverse events occurred in 103 of 295 patients (34.9%) in the tocilizumab group and in 55 of 143 patients (38.5%) in the placebo group. Mortality at day 28 was 19.7% in the tocilizumab group and 19.4% in the placebo group (weighted difference, 0.3 percentage points (95% CI, -7.6 to 8.2; nominal P = 0.94). CONCLUSIONS: In this randomized trial involving hospitalized patients with severe Covid-19 pneumonia, the use of tocilizumab did not result in significantly better clinical status or lower mortality than placebo at 28 days. (Funded by F. Hoffmann-La Roche and the Department of Health and Human Services; COVACTA ClinicalTrials.gov number, NCT04320615.).

3.
Contemp Clin Trials ; 103: 106330, 2021 Feb 22.
Artículo en Inglés | MEDLINE | ID: covidwho-1101134

RESUMEN

BACKGROUND AND AIMS: Retrospective studies have shown that angiotensin-converting-enzyme (ACE) inhibitors are associated with a reduced risk of complications and mortality in persons with novel coronavirus disease 2019 (COVID-19). Thus, we aimed to examine the efficacy of ramipril, an ACE-inhibitor, in preventing ICU admission, mechanical ventilation and/or mortality while also minimizing the risk of transmission and use of personal protective equipment (PPE). METHODS: RAMIC is a multicenter, randomized, double-blind, allocation-concealed, placebo-controlled trial comparing the efficacy of treatment with ramipril 2.5 mg orally daily compared to placebo for 14 days. The study population includes adult patients with COVID-19 who were admitted to a hospital or assessed in an emergency department or ambulatory clinic. Key exclusion criteria include ICU admission or need for mechanical ventilation at screening, use of an ACE inhibitor or angiotensin-receptor-II blocker within 7 days, glomerular filtration rate < 40 mL/min or a systolic blood pressure (BP) < 100 mmHg or diastolic BP < 65 mmHg. Patients are randomized 2:1 to receive ramipril (2.5 mg) or placebo daily. Informed consent and study visits occur virtually to minimize the risk of SARS-CoV-2 transmission and preserve PPE. The primary composite endpoint of ICU admission, invasive mechanical ventilation and death are adjudicated virtually. CONCLUSIONS: RAMIC is designed to assess the efficacy of treatment with ramipril for 14 days to decrease ICU admission, mechanical ventilator use and mortality in patients with COVID-19 and leverages virtual study visits and endpoint adjudication to mitigate risk of infection and to preserve PPE (ClinicalTrials.gov, NCT04366050).

5.
Endocr Pract ; 26(10): 1166-1172, 2020 Oct.
Artículo en Inglés | MEDLINE | ID: covidwho-1067866

RESUMEN

OBJECTIVE: Although type 2 diabetes mellitus (T2DM) has been reported as a risk factor for coronavirus disease 2019 (COVID-19), the effect of pharmacologic agents used to treat T2DM, such as metformin, on COVID-19 outcomes remains unclear. Metformin increases the expression of angiotensin converting enzyme 2, a known receptor for severe acute respiratory syndrome coronavirus 2. Data from people with T2DM hospitalized for COVID-19 were used to test the hypothesis that metformin use is associated with improved survival in this population. METHODS: Retrospective analyses were performed on de-identified clinical data from a major hospital in Wuhan, China, that included patients with T2DM hospitalized for COVID-19 during the recent epidemic. One hundred and thirty-one patients diagnosed with COVID-19 and T2DM were used in this study. The primary outcome was mortality. Demographic, clinical characteristics, laboratory data, diabetes medications, and respiratory therapy data were also included in the analysis. RESULTS: Of these 131 patients, 37 used metformin with or without other antidiabetes medications. Among the 37 metformin-taking patients, 35 (94.6%) survived and 2 (5.4%) did not survive. The mortality rates in the metformin-taking group versus the non-metformin group were 5.4% (2/37) versus 22.3% (21/94). Using multivariate analysis, metformin was found to be an independent predictor of survival in this cohort (P = .02). CONCLUSION: This study reveals a significant association between metformin use and survival in people with T2DM diagnosed with COVID-19. These clinical data are consistent with potential benefits of the use of metformin for COVID-19 patients with T2DM.


Asunto(s)
Diabetes Mellitus Tipo 2 , Metformina , China , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Diabetes Mellitus Tipo 2/epidemiología , Hospitalización , Humanos , Metformina/uso terapéutico , Estudios Retrospectivos
6.
Obesity (Silver Spring) ; 2021 Feb 02.
Artículo en Inglés | MEDLINE | ID: covidwho-1059411

RESUMEN

OBJECTIVE: Recent cohort studies have identified obesity as a risk factor for poor outcomes in coronavirus disease 2019 (COVID-19). To further explore the relationship between obesity and critical illness in COVID-19, the association of BMI with baseline demographic and intensive care unit (ICU) parameters, laboratory values, and outcomes in a critically ill patient cohort was examined. METHODS: In this retrospective study, the first 277 consecutive patients admitted to Massachusetts General Hospital ICUs with laboratory-confirmed COVID-19 were examined. BMI class, initial ICU laboratory values, physiologic characteristics including gas exchange and ventilatory mechanics, and ICU interventions as clinically available were measured. Mortality, length of ICU admission, and duration of mechanical ventilation were also measured. RESULTS: There was no difference found in respiratory system compliance or oxygenation between patients with and without obesity. Patients without obesity had higher initial ferritin and D-dimer levels than patients with obesity. Standard acute respiratory distress syndrome management, including prone ventilation, was equally distributed between BMI groups. There was no difference found in outcomes between BMI groups, including 30- and 60-day mortality and duration of mechanical ventilation. CONCLUSIONS: In this cohort of critically ill patients with COVID-19, obesity was not associated with meaningful differences in respiratory physiology, inflammatory profile, or clinical outcomes.

7.
Ann Glob Health ; 87(1): 1, 2021 01 04.
Artículo en Inglés | MEDLINE | ID: covidwho-1043783

RESUMEN

Background: UC San Diego Health System (UCSDHS) is an academic medical center and integrated care network in the US-Mexico border area of California contiguous to the Mexican Northern Baja region. The COVID-19 pandemic deeply influenced UCSDHS activities as new public health challenges increasingly related to high population density, cross-border traffic, economic disparities, and interconnectedness between cross-border communities, which accelerated development of clinical collaborations between UCSDHS and several border community hospitals - one in the US, two in Mexico - as high volumes of severely ill patients overwhelmed hospitals. Objective: We describe the development, implementation, feasibility, and acceptance of a novel critical care support program in three community hospitals along the US-Mexico border. Methods: We created and instituted a hybrid critical care program involving: 1) in-person activities to perform needs assessments of equipment and supplies and hands-on training and education, and 2) creation of a telemedicine-based (Tele-ICU) service for direct patient management and/or consultative, education-based experiences. We collected performance metrics surrounding adherence to evidence-based practices and staff perceptions of critical care delivery. Findings: In-person intervention phase identified and filled gaps in equipment and supplies, and Tele-ICU program promoted adherence to evidence-based practices and improved staff confidence in caring for critically ill COVID-19 patients at each hospital. Conclusion: A collaborative, hybrid critical care program across academic and community centers is feasible and effective to address cross-cultural public health emergencies.


Asunto(s)
Centros Médicos Académicos , Cuidados Críticos/métodos , Hospitales Comunitarios , Comunicación Interdisciplinaria , Telemedicina , Algoritmos , California , Cuidados Críticos/organización & administración , Equipos y Suministros de Hospitales , Medicina Basada en la Evidencia , Personal de Salud/educación , Humanos , Control de Infecciones/métodos , Unidades de Cuidados Intensivos , Cooperación Internacional , México , Enfermería/métodos , Autoeficacia
8.
J Physiol ; 599(4): 1057-1065, 2021 02.
Artículo en Inglés | MEDLINE | ID: covidwho-1030083

RESUMEN

The clinical presentation of COVID-19 due to infection with SARS-CoV-2 is highly variable with the majority of patients having mild symptoms while others develop severe respiratory failure. The reason for this variability is unclear but is in critical need of investigation. Some COVID-19 patients have been labelled with 'happy hypoxia', in which patient complaints of dyspnoea and observable signs of respiratory distress are reported to be absent. Based on ongoing debate, we highlight key respiratory and neurological components that could underlie variation in the presentation of silent hypoxaemia and define priorities for subsequent investigation.


Asunto(s)
Disnea , Humanos , Hipoxia
9.
Chest ; 2020 Dec 17.
Artículo en Inglés | MEDLINE | ID: covidwho-987252

RESUMEN

BACKGROUND: Objective and early identification of hospitalized patients, and particularly those with novel coronavirus disease 2019 (COVID-19), who may require mechanical ventilation (MV) may aid in delivering timely treatment. RESEARCH QUESTION: Can a transparent deep learning (DL) model predict the need for MV in hospitalized patients and those with COVID-19 up to 24 h in advance? STUDY DESIGN AND METHODS: We trained and externally validated a transparent DL algorithm to predict the future need for MV in hospitalized patients, including those with COVID-19, using commonly available data in electronic health records. Additionally, commonly used clinical criteria (heart rate, oxygen saturation, respiratory rate, Fio2, and pH) were used to assess future need for MV. Performance of the algorithm was evaluated using the area under receiver operating characteristic curve (AUC), sensitivity, specificity, and positive predictive value. RESULTS: We obtained data from more than 30,000 ICU patients (including more than 700 patients with COVID-19) from two academic medical centers. The performance of the model with a 24-h prediction horizon at the development and validation sites was comparable (AUC, 0.895 vs 0.882, respectively), providing significant improvement over traditional clinical criteria (P < .001). Prospective validation of the algorithm among patients with COVID-19 yielded AUCs in the range of 0.918 to 0.943. INTERPRETATION: A transparent DL algorithm improves on traditional clinical criteria to predict the need for MV in hospitalized patients, including in those with COVID-19. Such an algorithm may help clinicians to optimize timing of tracheal intubation, to allocate resources and staff better, and to improve patient care.

11.
Simul Healthc ; 2020 Oct 27.
Artículo en Inglés | MEDLINE | ID: covidwho-944546

RESUMEN

The COVID-19 pandemic led to disruption of most interprofessional simulation workshops in our center, including the obstetric and neonatal emergency simulation or ONE-Sim workshops for medical, nursing, midwifery students, and health professional staff in Australia and overseas.We devised online versions of the workshop for students and staff. In this report, we describe the details of these innovative online workshops. This has enabled us to continue this vital simulation-based education during the pandemic, when strict lockdowns, physical distance requirements, and travel restrictions precluded the usual conduct of these workshops.The online workshops were well received by students and staff in Australia and overseas. Some important lessons that were learned from the preliminary experience of these workshops are detailed in this report.

12.
Am J Crit Care ; 29(6): 418, 2020 11 01.
Artículo en Inglés | MEDLINE | ID: covidwho-902728
13.
Am J Respir Crit Care Med ; 202(3): 311-312, 2020 08 01.
Artículo en Inglés | MEDLINE | ID: covidwho-768168
14.
J Interprof Care ; 34(5): 706-710, 2020.
Artículo en Inglés | MEDLINE | ID: covidwho-759789

RESUMEN

This report describes the Obstetric and Neonatal Simulation (ONE-Sim) workshop run in a remote learning format for medical and midwifery students in an interprofessional setting during the COVID-19 pandemic. It explores the observation of students as participants in the online learning of using Personal Protective Equipment and simulation-based learning of perinatal emergency management. This was followed by their mutual interaction and reflections. This paper aims to understand the role of synchronous remote learning through simulation and its impact on interprofessional interactions. We describe the experience of medical and midwifery students with the ONE-Sim workshop, facilitated by medical (obstetric and neonatal) and midwifery educators. Formal thematic analysis will be performed as part of the ongoing study; however, initial direct observation demonstrated that students reacted positively to the online ONE-Sim workshop and engaged well with facilitators and peers. Students mutually interacted amongst themselves, shared their previous experiences, knowledge of roles as medical and midwifery practitioners and how they see themselves in those roles in a perinatal emergency setting. The initial observations demonstrate that interprofessional education delivered in an e-learning format can be useful and meaningful, and may be utilized across a number of specialties.


Asunto(s)
Infecciones por Coronavirus , Educación a Distancia , Comunicación Interdisciplinaria , Partería/educación , Pandemias , Neumonía Viral , Entrenamiento Simulado , Estudiantes de Medicina , Betacoronavirus , Cuidados Críticos , Humanos , Obstetricia/educación , Atención Perinatal , Evaluación de Programas y Proyectos de Salud , Grabación en Video
16.
Heart Lung ; 49(6): 686-687, 2020.
Artículo en Inglés | MEDLINE | ID: covidwho-720530

RESUMEN

Despite proven benefits to prone positioning in ARDS, a disconnect exists regarding the impressions of its utility among members of the healthcare team. While the majority of physicians view prone positioning as beneficial in ARDS, recent data suggest that the minority of ICU nurses have the same impression. The COVID pandemic has raised particularly challenges in terms of availability of personnel and supplies at least in some institutions. We discuss various barriers to implementation of prone positioning and suggest a number of strategies to optimize patient care. We use a multidisciplinary team approach to execute prone positioning in COVID ARDS.


Asunto(s)
Infecciones por Coronavirus , Pandemias , Posicionamiento del Paciente/métodos , Neumonía Viral , Posición Prona/fisiología , Actitud del Personal de Salud , Betacoronavirus , Infecciones por Coronavirus/enfermería , Infecciones por Coronavirus/terapia , Humanos , Neumonía Viral/enfermería , Neumonía Viral/terapia
17.
iScience ; 23(9): 101425, 2020 Jul 31.
Artículo en Inglés | MEDLINE | ID: covidwho-708530

RESUMEN

COVID-19 is becoming a leading cause of mortality throughout the world, and few effective therapies are currently available. Angiotensin converting enzyme 2 (ACE2) is essential to COVID-19 pathogenesis, as the binding of SARS-CoV-2 spike protein (S protein) is required for viral entry and development of COVID-19. ACE2 regulates the protective arm of the renin-angiotensin-aldosterone system (RAAS) that endows anti-hypertensive and anti-inflammatory effects in the cardiovascular and pulmonary systems. Preclinical data suggest ACE2 might be downregulated after SARS-CoV-2 binding, and treatments that increase ACE2 may prevent cardiopulmonary injury. Development, testing, and mass production of novel ACE2 therapies may take years, whereas more effective treatments for COVID-19 are needed urgently. Metformin is a widely available anti-diabetic agent that has an excellent safety profile, and clinical and preclinical data suggest metformin may offer cardiopulmonary protection in COVID-19 via enhanced ACE2 expression.

19.
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