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1.
Rev Paul Pediatr ; 39: e2020217, 2021.
Artículo en Portugués, Inglés | MEDLINE | ID: mdl-32876096

RESUMEN

OBJECTIVE: To analyze the current scientific literature to document, in an integrative review, the main findings that correlate Kawasaki disease (KD) to COVID-19. DATA SOURCES: The search was carried out in June 2020 in the following databases: Biblioteca Virtual em Saúde (BVS), periódico da CAPES and U.S National Library of Medicine (PubMed). The combination of descriptors used was [(COVID-19 OR SARS-CoV-2) AND (Kawasaki disease)], and the inclusion criteria stipulated were studies published from January 2019 to June 2020, without restriction of language or location, and available online in full. News, editorials, comments, and letters, as well as duplicates and articles that did not answer the guiding question were excluded. DATA SYNTHESIS: A total of 97 articles were identified, of which seven comprised this review. The association of KD to the new coronavirus appears to trigger a severe clinical condition of vasculitis. Different from the usual, in this inflammatory syndrome, patients are older, and prevalence is higher in children from African or Caribbean ancestry; clinical and laboratory manifestations are also atypical, with a predominance of abdominal complaints and exaggerated elevation of inflammatory markers. In addition, there was a greater report of rare complications and greater resistance to the recommended treatment for KD. CONCLUSIONS: Pediatric COVID-19 and its potential association to severe KD, still unfamiliar to health professionals, reinforces the importance of testing patients with vasculitis for the new coronavirus and the need to wage high surveillance and preparation of the health system during the current pandemic.


Asunto(s)
Infecciones por Coronavirus , Síndrome Mucocutáneo Linfonodular , Pandemias , Neumonía Viral , Síndrome de Respuesta Inflamatoria Sistémica/virología , Betacoronavirus/aislamiento & purificación , Niño , Infecciones por Coronavirus/epidemiología , Infecciones por Coronavirus/inmunología , Infecciones por Coronavirus/fisiopatología , Manejo de la Enfermedad , Humanos , Síndrome Mucocutáneo Linfonodular/epidemiología , Síndrome Mucocutáneo Linfonodular/terapia , Síndrome Mucocutáneo Linfonodular/virología , Neumonía Viral/epidemiología , Neumonía Viral/inmunología , Neumonía Viral/fisiopatología
2.
Euro Surveill ; 25(39)2020 10.
Artículo en Inglés | MEDLINE | ID: mdl-33006300

RESUMEN

We found that a single nucleotide polymorphism (SNP) in the nucleoprotein gene of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) from a patient interfered with detection in a widely used commercial assay. Some 0.2% of the isolates in the EpiCoV database contain this SNP. Although SARS-CoV-2 was still detected by the other probe in the assay, this underlines the necessity of targeting two independent essential regions of a pathogen for reliable detection.


Asunto(s)
Betacoronavirus/genética , Técnicas de Laboratorio Clínico , Infecciones por Coronavirus/diagnóstico , Nucleoproteínas/genética , Pandemias , Neumonía Viral/diagnóstico , Mutación Puntual , Polimorfismo de Nucleótido Simple , ARN Viral/genética , Reacción en Cadena en Tiempo Real de la Polimerasa , Proteínas Virales/genética , Secuencia de Bases , Betacoronavirus/aislamiento & purificación , Técnicas de Laboratorio Clínico/métodos , Trazado de Contacto , Infecciones por Coronavirus/virología , Cartilla de ADN , Errores Diagnósticos , Reacciones Falso Negativas , Femenino , Genes Virales , Humanos , Persona de Mediana Edad , Nasofaringe/virología , Nucleoproteínas/análisis , Filogenia , Neumonía Viral/virología , Reacción en Cadena en Tiempo Real de la Polimerasa/métodos , Rumanía , Enfermedad Relacionada con los Viajes , Proteínas Virales/análisis
3.
Biomed Res Int ; 2020: 1708267, 2020.
Artículo en Inglés | MEDLINE | ID: mdl-33029489

RESUMEN

We aimed to summarize reliable medical evidence by the meta-analysis of all published retrospective studies that examined data based on the detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by clinical symptoms, molecular (RT-PCR) diagnosis, and characteristic CT imaging features in pregnant women. The MEDLINE, PubMed, Scopus, ISI Web of Science, ClinicalKey, and CINAHL databases were used to select the studies. Then, 384 articles were received, including the studies until 01/May/2020. As a result of the full-text evaluation, 12 retrospective articles covering all the data related were selected. A total of 181 pregnant cases with SARS-CoV-2 infections were included in the meta-analysis within the scope of these articles. According to the results, the incidence of fever was 38.1% (95% CI: 14.2-65%) and cough was 22% (95% CI: 10.8-35.2%) among all clinical features of pregnant cases with SARS-CoV-2 infection. So, fever and cough are the most common symptoms in pregnant cases with SARS-CoV-2 infection, and 91.8% (95% CI: 76.7-99.9%) of RT-PCR results are positive. Moreover, abnormal CT incidence is 97.9% (95% CI: 94.2-99.9%) positive. No case was death. However, as this virus spreads globally, it should not be overlooked that the incidence will increase in pregnant women and maybe in the risky group. RT-PCR and CT can be used together in an accurate and safe diagnosis. In conclusion, these findings will provide important guidance for current studies regarding the clinical features and correct detection of SARS-CoV-2 infection in pregnant women, as well as whether it will create emergency tables that will require the use of a viral drug.


Asunto(s)
Técnicas de Laboratorio Clínico/métodos , Infecciones por Coronavirus/complicaciones , Infecciones por Coronavirus/diagnóstico , Neumonía Viral/complicaciones , Neumonía Viral/diagnóstico , Complicaciones Infecciosas del Embarazo/diagnóstico , Betacoronavirus/genética , Betacoronavirus/aislamiento & purificación , Infecciones por Coronavirus/epidemiología , Femenino , Humanos , Pandemias , Neumonía Viral/epidemiología , Embarazo , ARN Viral/análisis , ARN Viral/genética , Estudios Retrospectivos , Reacción en Cadena de la Polimerasa de Transcriptasa Inversa , Tomografía Computarizada por Rayos X
4.
Biomed Res Int ; 2020: 7610678, 2020.
Artículo en Inglés | MEDLINE | ID: mdl-33029522

RESUMEN

Background: There is a shortage of chemical reagents for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) diagnosis and a surge of SARS-CoV-2 cases, especially in limited-resource settings. Therefore, the combination of an optimal assay kit is necessary. Methods: We compared the ability to screen SARS-CoV-2 among three primer-probe sets in two different master mixes, Invitrogen™ SuperScript™ III One-Step RT-PCR and LightCycler Multiplex RNA Virus Master. Results: The assay with TIB-Molbiol, IDT, and Phu Sa sets for LightCycler Multiplex RNA Virus Master or Invitrogen™ SuperScript™ III One-Step RT-PCR showed positive results from a single reaction of triplicate in the three days of 4.8 copies per reaction. R squared and amplification efficiency were 0.97 and ranged from 107 to 108%, respectively. Conclusions: Our findings indicated that TIB-Molbiol, IDT, and Phu Sa primer-probe sets could be beneficial for the laboratory screening of SARS-CoV-2 by RT-qPCR assay of E gene. There is a need to consider the combination of these reagent sets as a new strategy to increase the testing capacity of screening programs for COVID-19.


Asunto(s)
Betacoronavirus/genética , Técnicas de Laboratorio Clínico/métodos , Infecciones por Coronavirus/diagnóstico , Cartilla de ADN/genética , Neumonía Viral/diagnóstico , Sondas ARN/genética , Betacoronavirus/aislamiento & purificación , Técnicas de Laboratorio Clínico/estadística & datos numéricos , Infecciones por Coronavirus/epidemiología , Infecciones por Coronavirus/virología , Humanos , Reacción en Cadena de la Polimerasa Multiplex/métodos , Reacción en Cadena de la Polimerasa Multiplex/estadística & datos numéricos , Pandemias , Neumonía Viral/epidemiología , Neumonía Viral/virología , ARN Viral/genética , Reacción en Cadena en Tiempo Real de la Polimerasa/métodos , Reacción en Cadena en Tiempo Real de la Polimerasa/estadística & datos numéricos , Reacción en Cadena de la Polimerasa de Transcriptasa Inversa/métodos , Reacción en Cadena de la Polimerasa de Transcriptasa Inversa/estadística & datos numéricos , Sensibilidad y Especificidad
5.
Biomed Res Int ; 2020: 2854186, 2020.
Artículo en Inglés | MEDLINE | ID: mdl-33015160

RESUMEN

Objectives: To evaluate the role of short-term low-dose glucocorticoids in mild COVID-19 patients. Methods: We conducted a retrospective, cross-sectional, single-center study in Kunming, China. A total of 33 mild COVID-19 cases were divided into two treatment groups (with and without glucocorticoids, methylprednisolone, were used in this setting), and the absolute value of peripheral blood lymphocyte count; CD3+, CD4+, and CD8+ T cell counts; and the time to achieve negative transformation of a nucleic acid pharyngeal swab were recorded. Peripheral blood lymphocyte and T cell counts were compared between the treatment group and 25 healthy individuals. At the point of time when there was a 50% accumulation conversion rate (positive to negative nucleic acid on pharyngeal swab), and the nucleic acid turned negative in half of the patients in two groups, the peripheral blood lymphocyte and T cell counts were compared between treatment groups. Results: The mean cumulative time for the 50% negative conversion rate of the nucleic acid in the pharyngeal swab was 17.7 ± 5.1 days and 13.9 ± 5.4 days in the glucocorticoid group and the nonglucocorticoid group, respectively. The absolute peripheral blood lymphocyte count and the T cell subset count in the glucocorticoid group were lower than those in the nonglucocorticoid group. When the nucleic acid turned negative in half of the patients, the absolute value of peripheral blood lymphocyte count and CD4+ T cells of the glucocorticoid group and the nonglucocorticoid group was not significantly different; the CD3+ and CD8+ T cells in the glucocorticoid group were lower than those in the nonglucocorticoid group. The absolute peripheral blood lymphocyte count, CD3+ T cells, and CD4+ T cells in the glucocorticoid group were lower than those of the healthy group during the whole disease period, and CD8+ T cells returned to normal at 19-21 days of the disease period. There was no significant difference between the nonglucocorticoid group and the healthy group for absolute peripheral blood lymphocyte and CD8+ T cells; moreover, CD3+ T cells and CD4+ T cells were lower in the nonglucocorticoid group than those in the healthy group from the day of admission to the 18th day and returned to normal at the period of 19-21 days. The absolute peripheral lymphocyte count (P = 0.048, effect size d = 0.727) and T cell subset count (CD3: P = 0.042, effect size d = 0.655; CD4: P < 0.01, effect size d = 0.599; and CD8: P = 0.034, effect size d = 0.550) in the nonglucocorticoid group were higher than those in the glucocorticoid group, and the difference between the groups was statistically significant. Conclusions: This study found that the use of short-term, low-dose glucocorticoids does not negatively influence the clinical outcome, without affecting the final clearance of viral nucleic acid in mild COVID-19 patients.


Asunto(s)
Betacoronavirus , Infecciones por Coronavirus/tratamiento farmacológico , Glucocorticoides/administración & dosificación , Neumonía Viral/tratamiento farmacológico , Adolescente , Adulto , Betacoronavirus/aislamiento & purificación , Niño , China/epidemiología , Infecciones por Coronavirus/inmunología , Infecciones por Coronavirus/virología , Estudios Transversales , Femenino , Humanos , Recuento de Linfocitos , Masculino , Metilprednisolona/administración & dosificación , Persona de Mediana Edad , Pandemias , Neumonía Viral/inmunología , Neumonía Viral/virología , Estudios Retrospectivos , Subgrupos de Linfocitos T/inmunología , Factores de Tiempo , Resultado del Tratamiento , Adulto Joven
6.
Int J Mol Sci ; 21(19)2020 Sep 29.
Artículo en Inglés | MEDLINE | ID: mdl-33003377

RESUMEN

The world is currently experiencing the worst health pandemic since the Spanish flu in 1918-the COVID-19 pandemic-caused by the coronavirus severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). This pandemic is the world's third wake-up call this century. In 2003 and 2012, the world experienced two major coronavirus outbreaks, SARS-CoV-1 and Middle East Respiratory syndrome coronavirus (MERS-CoV), causing major respiratory tract infections. At present, there is neither a vaccine nor a cure for COVID-19. The severe COVID-19 symptoms of hyperinflammation, catastrophic damage to the vascular endothelium, thrombotic complications, septic shock, brain damage, acute disseminated encephalomyelitis (ADEM), and acute neurological and psychiatric complications are unprecedented. Many COVID-19 deaths result from the aftermath of hyperinflammatory complications, also referred to as the "cytokine storm syndrome", endotheliitus and blood clotting, all with the potential to cause multiorgan dysfunction. The sphingolipid rheostat plays integral roles in viral replication, activation/modulation of the immune response, and importantly in maintaining vasculature integrity, with sphingosine 1 phosphate (S1P) and its cognate receptors (SIPRs: G-protein-coupled receptors) being key factors in vascular protection against endotheliitus. Hence, modulation of sphingosine kinase (SphK), S1P, and the S1P receptor pathway may provide significant beneficial effects towards counteracting the life-threatening, acute, and chronic complications associated with SARS-CoV-2 infection. This review provides a comprehensive overview of SARS-CoV-2 infection and disease, prospective vaccines, and current treatments. We then discuss the evidence supporting the targeting of SphK/S1P and S1P receptors in the repertoire of COVID-19 therapies to control viral replication and alleviate the known and emerging acute and chronic symptoms of COVID-19. Three clinical trials using FDA-approved sphingolipid-based drugs being repurposed and evaluated to help in alleviating COVID-19 symptoms are discussed.


Asunto(s)
Betacoronavirus/efectos de los fármacos , Infecciones por Coronavirus/tratamiento farmacológico , Lisofosfolípidos/metabolismo , Fosfotransferasas (Aceptor de Grupo Alcohol)/antagonistas & inhibidores , Neumonía Viral/tratamiento farmacológico , Esfingolípidos/farmacología , Receptores de Esfingosina-1-Fosfato/antagonistas & inhibidores , Esfingosina/análogos & derivados , Replicación Viral/efectos de los fármacos , Betacoronavirus/aislamiento & purificación , Humanos , Pandemias , Esfingosina/metabolismo
7.
BMC Nephrol ; 21(1): 419, 2020 10 01.
Artículo en Inglés | MEDLINE | ID: mdl-33004002

RESUMEN

BACKGROUND: Infection with the severe acute respiratory coronavirus 2 (SARS-CoV-2) has led to a worldwide pandemic with coronavirus disease 2019 (COVID-19), the disease caused by SARS-CoV-2, overwhelming healthcare systems globally. Preliminary reports suggest a high incidence of infection and mortality with SARS-CoV-2 in patients receiving kidney replacement therapy (KRT). The aims of this study are to report characteristics, rates and outcomes of all patients affected by infection with SARS-CoV-2 undergoing KRT in Scotland. METHODS: Study design was an observational cohort study. Data were linked between the Scottish Renal Registry, Health Protection Scotland and the Scottish Intensive Care Society Audit Group national data sets using a unique patient identifier (Community Health Index (CHI)) for each individual by the Public Health and Intelligence unit of Public Health, Scotland. Descriptive statistics and survival analyses were performed. RESULTS: During the period 1st March 2020 to 31st May 2020, 110 patients receiving KRT tested positive for SARS-CoV-2 amounting to 2% of the prevalent KRT population. Of those affected, 86 were receiving haemodialysis or peritoneal dialysis and 24 had a renal transplant. Patients who tested positive were older and more likely to reside in more deprived postcodes. Mortality was high at 26.7% in the dialysis patients and 29.2% in the transplant patients. CONCLUSION: The rate of detected SARS-CoV-2 in people receiving KRT in Scotland was relatively low but with a high mortality for those demonstrating infection. Although impossible to confirm, it appears that the measures taken within dialysis units coupled with the national shielding policy, have been effective in protecting this population from infection.


Asunto(s)
Betacoronavirus/aislamiento & purificación , Control de Enfermedades Transmisibles/organización & administración , Infecciones por Coronavirus , Fallo Renal Crónico , Trasplante de Riñón/estadística & datos numéricos , Pandemias , Neumonía Viral , Terapia de Reemplazo Renal , Comorbilidad , Infecciones por Coronavirus/diagnóstico , Infecciones por Coronavirus/epidemiología , Infecciones por Coronavirus/prevención & control , Femenino , Humanos , Fallo Renal Crónico/epidemiología , Fallo Renal Crónico/cirugía , Fallo Renal Crónico/terapia , Masculino , Persona de Mediana Edad , Mortalidad , Evaluación de Procesos y Resultados en Atención de Salud , Pandemias/prevención & control , Neumonía Viral/diagnóstico , Neumonía Viral/epidemiología , Neumonía Viral/prevención & control , Salud Pública/métodos , Sistema de Registros/estadística & datos numéricos , Terapia de Reemplazo Renal/métodos , Terapia de Reemplazo Renal/estadística & datos numéricos , Escocia/epidemiología
8.
BMJ Open ; 10(10): e038390, 2020 10 01.
Artículo en Inglés | MEDLINE | ID: mdl-33004397

RESUMEN

INTRODUCTION: In order to avoid unnecessary hospital admission and associated complications, there is an urgent need to improve the early detection of infection in nursing home residents. Monitoring signs and symptoms with checklists or aids called decision support tools may help nursing home staff to detect infection in residents, particularly during the current COVID-19 pandemic.We plan to conduct a survey exploring views and experiences of how infections are detected and managed in practice by nurses, care workers and managers in nursing homes in England and Sweden. METHODS AND ANALYSIS: An international cross-sectional descriptive survey, using a pretested questionnaire, will be used to explore nurses, care workers and managers views and experiences of how infections are detected and managed in practice in nursing homes. Data will be analysed descriptively and univariate associations between personal and organisational factors explored. This will help identify important factors related to awareness, knowledge, attitudes, belief and skills likely to affect future implementation of a decision support tool for the early detection of infection in nursing home residents. ETHICS AND DISSEMINATION: This study was approved using the self-certification process at the University of Surrey and Linköping University ethics committee (Approval 2018/514-32) in 2018. Study findings will be disseminated through community/stakeholder/service user engagement events in each country, publication in academic peer-reviewed journals and conference presentations. A LAY summary will be provided to participants who indicate they would like to receive this information.This is the first stage of a plan of work to revise and evaluate the Early Detection of Infection Scale (EDIS) tool and its effect on managing infections and reducing unplanned hospital admissions in nursing home residents. Implementation of the EDIS tool may have important implications for the healthcare economy; this will be explored in cost-benefit analyses as the work progresses.


Asunto(s)
Control de Enfermedades Transmisibles , Infecciones por Coronavirus , Uso Excesivo de los Servicios de Salud/prevención & control , Casas de Salud/estadística & datos numéricos , Pandemias , Manejo de Atención al Paciente , Neumonía Viral , Instituciones de Cuidados Especializados de Enfermería/estadística & datos numéricos , Betacoronavirus/aislamiento & purificación , Control de Enfermedades Transmisibles/métodos , Control de Enfermedades Transmisibles/organización & administración , Infecciones por Coronavirus/diagnóstico , Infecciones por Coronavirus/epidemiología , Infecciones por Coronavirus/terapia , Análisis Costo-Beneficio , Estudios Transversales , Inglaterra/epidemiología , Conocimientos, Actitudes y Práctica en Salud , Personal de Salud/normas , Hospitalización , Humanos , Manejo de Atención al Paciente/economía , Manejo de Atención al Paciente/métodos , Neumonía Viral/diagnóstico , Neumonía Viral/epidemiología , Neumonía Viral/terapia , Gestión de la Práctica Profesional/economía , Proyectos de Investigación , Suecia/epidemiología
9.
J Cancer Res Ther ; 16(5): 974-978, 2020 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-33004737

RESUMEN

The pandemic of coronavirus disease 2019 (COVID-19) has become a major public health threat to the whole world. Although the control of COVID-19 has been in the forefront of interventional practice, most interventional radiologists (IRs) are not equipped adequately to cope with such a crisis. In this review, we share our experience from Chinese IRs' perspective, report on the acute measures instituted within interventional radiology (IR) units, and give recommendations to the prevention and control of COVID-19.


Asunto(s)
Betacoronavirus/aislamiento & purificación , Infecciones por Coronavirus/prevención & control , Control de Infecciones/normas , Pandemias/prevención & control , Equipo de Protección Personal/normas , Neumonía Viral/prevención & control , Pautas de la Práctica en Medicina/normas , Radiología Intervencional/métodos , Infecciones por Coronavirus/epidemiología , Infecciones por Coronavirus/transmisión , Infecciones por Coronavirus/virología , Humanos , Neumonía Viral/epidemiología , Neumonía Viral/transmisión , Neumonía Viral/virología , Radiología Intervencional/instrumentación
10.
Med Gas Res ; 10(3): 134-138, 2020.
Artículo en Inglés | MEDLINE | ID: mdl-33004712

RESUMEN

Coronavirus disease 2019 (COVID-19) is the respiratory disease caused by the novel severe acute respiratory syndrome-coronavirus-2 and is characterized by clinical manifestations ranging from mild, flu-like symptoms to severe respiratory insufficiency and multi-organ failure. Patients with more severe symptoms may require intensive care treatments and face a high mortality risk. Also, thrombotic complications such as pulmonary embolisms and disseminated intravascular coagulation are frequent in these patients. Indeed, COVID-19 is characterized by an abnormal inflammatory response resembling a cytokine storm, which is associated to endothelial dysfunction and microvascular complications. To date, no specific treatments are available for COVID-19 and its life-threatening complication. Immunomodulatory drugs, such as hydroxychloroquine and interleukin-6 inhibitors, as well as antithrombotic drugs such as heparin and low molecular weight heparin, are currently being administered with some benefit. Ozone therapy consists in the administration of a mixture of ozone and oxygen, called medical ozone, which has been used for over a century as an unconventional medicine practice for several diseases. Medical ozone rationale in COVID-19 is the possibility of contrasting endothelial dysfunction, modulating the immune response and acting as a virustatic agent. Thus, medical ozone could help to decrease lung inflammation, slow down viral growth, regulate lung circulation and oxygenation and prevent microvascular thrombosis. Ozone-therapy could be considered a feasible, cost-effective and easy to administer adjuvant therapy while waiting for the synthesis of a therapy or the development of the vaccine.


Asunto(s)
Betacoronavirus/aislamiento & purificación , Infecciones por Coronavirus/terapia , Ozono/uso terapéutico , Neumonía Viral/terapia , Terapia Combinada , Infecciones por Coronavirus/fisiopatología , Infecciones por Coronavirus/virología , Humanos , Pandemias , Neumonía Viral/fisiopatología , Neumonía Viral/virología , Resultado del Tratamiento
11.
Can Respir J ; 2020: 2045341, 2020.
Artículo en Inglés | MEDLINE | ID: mdl-33005276

RESUMEN

Objective: Coronavirus disease 2019 (COVID-19), caused by the novel coronavirus SARS-CoV-2, was first identified in December 2019 in Wuhan, China, and has since spread globally, resulting in an ongoing pandemic. However, the study of asymptomatic patients is still rare, and the understanding of its potential transmission risk is still insufficient. In this study, epidemiological investigations were conducted in the Zhejiang province to understand the epidemiology and clinical characteristics of asymptomatic patients with COVID-19. Methods: This retrospective study was carried out on 22 asymptomatic patients and 234 symptomatic patients with COVID-19 who were hospitalized in Zhejiang Duodi Hospital from January 21 to March 16, 2020. The characteristics of epidemiology, demography, clinical manifestations, and laboratory data of mild patients were compared and analyzed. Results: The median age was 28 years in asymptomatic patients and 48 years in symptomatic patients. The proportion who were female was 77.3% in asymptomatic patients and 36.3% in symptomatic patients (p < 0.001). The proportion of patients with coexisting diseases was 4.5% in asymptomatic patients and 38.0% in symptomatic patients (p=0.002). The proportion of patients with increased CRP was 13.6% in the asymptomatic group and 61.1% in the symptomatic group (p < 0.001). The proportion of patients received antiviral therapy was 45.5% in the asymptomatic group and 97.9% in the symptomatic group (p < 0.001). The proportion of patients received oxygen therapy was 22.7% in the asymptomatic group and 99.1% in symptomatic patients (p < 0.001). By March 16, 2020, all patients were discharged from the hospital, and no symptoms had appeared in the asymptomatic patients during hospitalization. The median course of infection to discharge was 21.5 days in asymptomatic patients and 22 days in symptomatic patients. Conclusions: Asymptomatic patients are also infectious; relying only on clinical symptoms, blood cell tests, and radiology examination will lead to misdiagnosis of most patients, leading to the spread of the virus. Investigation of medical history is the best strategy for screening asymptomatic patients, especially young people, women, and people without coexisting disease, who are more likely to be asymptomatic when infected. Although the prognosis is good, isolation is critical for asymptomatic patients, and it is important not to end isolation early before a nucleic acid test turns negative.


Asunto(s)
Enfermedades Asintomáticas , Infecciones por Coronavirus , Transmisión de Enfermedad Infecciosa/prevención & control , Pandemias , Neumonía Viral , Medición de Riesgo/métodos , Adulto , Factores de Edad , Enfermedades Asintomáticas/epidemiología , Enfermedades Asintomáticas/terapia , Betacoronavirus/aislamiento & purificación , China/epidemiología , Comorbilidad , Infecciones por Coronavirus/diagnóstico , Infecciones por Coronavirus/tratamiento farmacológico , Infecciones por Coronavirus/epidemiología , Infecciones por Coronavirus/fisiopatología , Infecciones por Coronavirus/terapia , Errores Diagnósticos/prevención & control , Femenino , Hospitalización/estadística & datos numéricos , Humanos , Masculino , Persona de Mediana Edad , Terapia por Inhalación de Oxígeno/estadística & datos numéricos , Neumonía Viral/diagnóstico , Neumonía Viral/epidemiología , Neumonía Viral/fisiopatología , Neumonía Viral/terapia , Pronóstico , Factores Sexuales
12.
BMC Bioinformatics ; 21(1): 431, 2020 Oct 02.
Artículo en Inglés | MEDLINE | ID: mdl-33008363

RESUMEN

BACKGROUND: This paper describes a web based tool that uses a combination of sonification and an animated display to inquire into the SARS-CoV-2 genome. The audio data is generated in real time from a variety of RNA motifs that are known to be important in the functioning of RNA. Additionally, metadata relating to RNA translation and transcription has been used to shape the auditory and visual displays. Together these tools provide a unique approach to further understand the metabolism of the viral RNA genome. This audio provides a further means to represent the function of the RNA in addition to traditional written and visual approaches. RESULTS: Sonification of the SARS-CoV-2 genomic RNA sequence results in a complex auditory stream composed of up to 12 individual audio tracks. Each auditory motive is derived from the actual RNA sequence or from metadata. This approach has been used to represent transcription or translation of the viral RNA genome. The display highlights the real-time interaction of functional RNA elements. The sonification of codons derived from all three reading frames of the viral RNA sequence in combination with sonified metadata provide the framework for this display. Functional RNA motifs such as transcription regulatory sequences and stem loop regions have also been sonified. Using the tool, audio can be generated in real-time from either genomic or sub-genomic representations of the RNA. Given the large size of the viral genome, a collection of interactive buttons has been provided to navigate to regions of interest, such as cleavage regions in the polyprotein, untranslated regions or each gene. These tools are available through an internet browser and the user can interact with the data display in real time. CONCLUSION: The auditory display in combination with real-time animation of the process of translation and transcription provide a unique insight into the large body of evidence describing the metabolism of the RNA genome. Furthermore, the tool has been used as an algorithmic based audio generator. These audio tracks can be listened to by the general community without reference to the visual display to encourage further inquiry into the science.


Asunto(s)
Betacoronavirus/genética , Genoma Viral , Programas Informáticos , Betacoronavirus/aislamiento & purificación , Infecciones por Coronavirus/patología , Infecciones por Coronavirus/virología , Genómica , Humanos , Sistemas de Lectura Abierta/genética , Pandemias , Neumonía Viral/patología , Neumonía Viral/virología , ARN Viral/química , ARN Viral/genética , ARN Viral/metabolismo
13.
Transl Psychiatry ; 10(1): 337, 2020 10 02.
Artículo en Inglés | MEDLINE | ID: mdl-33009366

RESUMEN

Data are scarce regarding the comorbid mental disorders and their management among COVID-19 patients. This study described the clinical characteristics and management of COVID-19 patients treated in psychiatric inpatient settings due to comorbid first-onset mental disorders in Wuhan, China. This electronic medical records-based study included 25 COVID-19 patients with first-onset mental disorders and 55 patients with first-onset mental disorders without COVID-19 (control group). Data collected included ICD-10 diagnoses of mental disorders, psychiatric and respiratory symptoms, treatments, and outcomes. Adjustment disorder (n = 11, 44.0%) and acute and transient psychotic disorders, with associated acute stress (n = 6, 24.0%) were main clinical diagnoses in the COVID-19 group while serious mental illnesses (i.e., schizophrenia, 24.5%) and alcohol use disorders (10.9%) were overrepresented in the control group. On admission, the most common psychiatric symptom in COVID-19 patients was insomnia symptoms (n = 18, 72.0%), followed by aggressive behaviors (n = 16, 64.0%), delusion (n = 10, 40.0%), and severe anxiety (n = 9, 36.0%). In addition to respiratory treatments, 76.0% COVID-19 patients received antipsychotics, 40.0% sedative-hypnotics, and 24.0% mood stabilizers. At the end of inpatient treatment, 4 (16.0%) COVID-19 patients were transferred to other hospitals to continue respiratory treatment after their psychiatric symptoms were controlled while the remaining 21 (84.0%) all recovered. Compared to the control group, COVID-19 group had significantly shorter length of hospital stay (21.2 vs. 37.4 days, P < 0.001). Adjustment disorder and acute and transient psychotic disorders are the main clinical diagnoses of COVID-19 patients managed in psychiatric inpatient settings. The short-term prognosis of these patients is good after conventional psychotropic treatment.


Asunto(s)
Betacoronavirus/aislamiento & purificación , Infecciones por Coronavirus , Hospitalización/estadística & datos numéricos , Trastornos Mentales , Pandemias , Neumonía Viral , Psicotrópicos , China/epidemiología , Comorbilidad , Infecciones por Coronavirus/epidemiología , Infecciones por Coronavirus/psicología , Infecciones por Coronavirus/terapia , Registros Electrónicos de Salud/estadística & datos numéricos , Femenino , Humanos , Masculino , Trastornos Mentales/epidemiología , Trastornos Mentales/fisiopatología , Trastornos Mentales/psicología , Trastornos Mentales/terapia , Persona de Mediana Edad , Manejo de Atención al Paciente/métodos , Neumonía Viral/epidemiología , Neumonía Viral/psicología , Neumonía Viral/terapia , Pronóstico , Escalas de Valoración Psiquiátrica , Psicotrópicos/clasificación , Psicotrópicos/uso terapéutico , Evaluación de Síntomas/métodos , Evaluación de Síntomas/estadística & datos numéricos
14.
Colomb Med (Cali) ; 51(2): e4320, 2020 Jun 30.
Artículo en Inglés | MEDLINE | ID: mdl-33012891

RESUMEN

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) which causes coronavirus disease 2019 (COVID-19) has resulted in a global health crisis. Prior to the arrival of this viral pandemic, the world was already plagued with a significant burden of cardiovascular disease. With the introduction of the novel virus, the world now faces a double jeapordy. Early reports have suggested an increased risk of death in individuals with underlying cardio-metabolic disorders. The exact effects of COVID-19 on the cardiovascular system are not well determined, however lessons from prior viral epidemics suggest that such infections can trigger acute coronary syndromes, arrhythmias and heart failure via direct and indirect mechanisms. In this article, we aimed to discuss the effects and potential underlying mechanisms of COVID -19 as well as potential implications of treatments targeted against this virus on the cardiovascular system.


Asunto(s)
Enfermedades Cardiovasculares/epidemiología , Infecciones por Coronavirus/epidemiología , Neumonía Viral/epidemiología , Betacoronavirus/aislamiento & purificación , Enfermedades Cardiovasculares/fisiopatología , Enfermedades Cardiovasculares/virología , Infecciones por Coronavirus/complicaciones , Infecciones por Coronavirus/terapia , Humanos , Pandemias , Neumonía Viral/complicaciones , Neumonía Viral/terapia , Factores de Riesgo
15.
Aust J Gen Pract ; 49(10): 656-661, 2020 10.
Artículo en Inglés | MEDLINE | ID: mdl-33015681

RESUMEN

BACKGROUND: Patients with red eyes frequently present to general practitioners (GPs). Although infrequent, some patients with COVID-19 may present with features typical of viral conjunctivitis. SARS-CoV-2 is expressed at a low rate in tears, which may be a source of infection to GPs caring for patients at high risk of COVID­19. OBJECTIVE: The aims of this article are to outline: 1) ophthalmic complications of SARS-CoV-2 infection, 2) triage and management of patients with potential COVID-19 conjunctivitis, and 3) triage and management of patients with red eyes during the current COVID-19 pandemic. DISCUSSION: It is important that GPs: 1) have a high index of suspicion that patients with apparently typical viral conjunctivitis may have an uncommon presentation of COVID-19 illness, 2) develop appropriate telephone triage systems to reduce patient consultations, and 3) foster relationships with their ophthalmologist and optometrist colleagues who can provide phone advice, guidance on treatment initiation and definitive care when necessary.


Asunto(s)
Betacoronavirus/aislamiento & purificación , Conjuntivitis , Infecciones por Coronavirus , Control de Infecciones , Transmisión de Enfermedad Infecciosa de Paciente a Profesional/prevención & control , Pandemias , Neumonía Viral , Triaje/métodos , Comorbilidad , Conjuntivitis/diagnóstico , Conjuntivitis/epidemiología , Conjuntivitis/virología , Infecciones por Coronavirus/epidemiología , Infecciones por Coronavirus/fisiopatología , Infecciones por Coronavirus/terapia , Diagnóstico Diferencial , Técnicas de Diagnóstico Oftalmológico , Médicos Generales , Humanos , Control de Infecciones/métodos , Control de Infecciones/organización & administración , Exposición Profesional/prevención & control , Neumonía Viral/epidemiología , Neumonía Viral/fisiopatología , Neumonía Viral/terapia , Lágrimas/virología
16.
Medwave ; 20(8): e8037, 2020 Sep 25.
Artículo en Español, Inglés | MEDLINE | ID: mdl-33017386

RESUMEN

Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) causes COVID-19 (Coronavirus disease 2019). This disease was detected in the city of Wuhan in China in December 2019. People infected with COVID-19 shows varying manifestations, depending on their health and age. The most common symptoms are fever, cough, myalgia, fatigue, odynophagia, and dyspnea. Infected adults older 60 years of age are the group of patients most susceptible to severe COVID-19 states and present comor-bidity in the presence of chronic diseases. On the other hand, it is also essential to have tests to detect SARS-COV-2 in people and follow the evolution of COVID-19 quickly, reliably, and cheap. To achieve this, there are real-time reverse transcription pol-ymerase chain reaction (RT-PCR) tests, isothermal nucleic acid amplification, and enzyme immunostimulation. Currently, there are no drug treatments to prevent infection and to combat the virus's effects. However, different research groups that are conduct-ing in vitro, in vivo, and in silico tests to find drugs able to provide an immune response and to control infection in humans with SARS-CoV-2. Chloroquine, hydroxychloroquine, remdesivir, interferon-2b, and oseltamivir are some pharmacological options evaluated in clinical trials for prophylaxis of COVID-19. The purpose of this review is to establish a reference framework for taxonomic classification of SARS-CoV-2 and the relationship they have with other CoVs, as well as their structure and propaga-tion pathways in humans. The characteristics and symptoms presented by patients with COVID-19, the detection methods, and possible treatments are also presented.


Asunto(s)
Técnicas de Laboratorio Clínico , Infecciones por Coronavirus/epidemiología , Neumonía Viral/epidemiología , Factores de Edad , Betacoronavirus/clasificación , Betacoronavirus/aislamiento & purificación , Infecciones por Coronavirus/diagnóstico , Infecciones por Coronavirus/tratamiento farmacológico , Humanos , Pandemias , Neumonía Viral/diagnóstico , Neumonía Viral/tratamiento farmacológico , Factores de Riesgo
17.
BMJ Open ; 10(10): e039887, 2020 10 05.
Artículo en Inglés | MEDLINE | ID: mdl-33020106

RESUMEN

OBJECTIVES: To determine the age-specific clinical presentations and incidence of adverse outcomes among patients with COVID-19 in Jiangsu, China. DESIGN AND SETTING: Retrospective, multicentre cohort study performed at 24 hospitals in Jiangsu, China. PARTICIPANTS: 625 patients with COVID-19 enrolled between 10 January and 15 March 2020. RESULTS: Of the 625 patients (median age, 46 years; 329 (52.6%) men), 37 (5.9%) were children (18 years or younger), 261 (41.8%) young adults (19-44 years), 248 (39.7%) middle-aged adults (45-64 years) and 79 (12.6%) elderly adults (65 years or older). The incidence of hypertension, coronary heart disease, chronic obstructive pulmonary disease and diabetes comorbidities increased with age (trend test, p<0.0001, p=0.0003, p<0.0001 and p<0.0001, respectively). Fever, cough and shortness of breath occurred more commonly among older patients, especially the elderly, compared with children (χ2 test, p=0.0008, 0.0146 and 0.0282, respectively). The quadrant score and pulmonary opacity score increased with age (trend test, both p<0.0001). Older patients had many significantly different laboratory parameters from younger patients. Elderly patients had the highest proportion of severe or critically-ill cases (33.0%, χ2 test p<0.0001), intensive care unit use (35.4%, χ2 test p<0.0001), respiratory failure (31.6%, χ2 test p<0.0001) and the longest hospital stay (median 21 days, Kruskal-Wallis test p<0.0001). CONCLUSIONS: Elderly (≥65 years) patients with COVID-19 had the highest risk of severe or critical illness, intensive care use, respiratory failure and the longest hospital stay, which may be due partly to their having a higher incidence of comorbidities and poor immune responses to COVID-19.


Asunto(s)
Factores de Edad , Infecciones por Coronavirus , Cuidados Críticos , Pulmón/diagnóstico por imagen , Pandemias , Neumonía Viral , Evaluación de Síntomas , Adolescente , Anciano , Betacoronavirus/aislamiento & purificación , China/epidemiología , Estudios de Cohortes , Comorbilidad , Infecciones por Coronavirus/diagnóstico , Infecciones por Coronavirus/epidemiología , Infecciones por Coronavirus/fisiopatología , Cuidados Críticos/métodos , Cuidados Críticos/estadística & datos numéricos , Enfermedad Crítica/epidemiología , Femenino , Humanos , Masculino , Persona de Mediana Edad , Neumonía Viral/diagnóstico , Neumonía Viral/epidemiología , Neumonía Viral/fisiopatología , Estudios Retrospectivos , Medición de Riesgo , Índice de Severidad de la Enfermedad , Evaluación de Síntomas/métodos , Evaluación de Síntomas/estadística & datos numéricos
18.
BMJ Open ; 10(10): e044566, 2020 10 05.
Artículo en Inglés | MEDLINE | ID: mdl-33020111

RESUMEN

OBJECTIVES: To analyse enrolment to interventional trials during the first wave of the COVID-19 pandemic in England and describe the barriers to successful recruitment in the circumstance of a further wave or future pandemics. DESIGN: We analysed registered interventional COVID-19 trial data and concurrently did a prospective observational study of hospitalised patients with COVID-19 who were being assessed for eligibility to one of the RECOVERY, C19-ACS or SIMPLE trials. SETTING: Interventional COVID-19 trial data were analysed from the clinicaltrials.gov and International Standard Randomized Controlled Trial Number databases on 12 July 2020. The patient cohort was taken from five centres in a respiratory National Institute for Health Research network. Population and modelling data were taken from published reports from the UK government and Medical Research Council Biostatistics Unit. PARTICIPANTS: 2082 consecutive admitted patients with laboratory-confirmed SARS-CoV-2 infection from 27 March 2020 were included. MAIN OUTCOME MEASURES: Proportions enrolled, and reasons for exclusion from the aforementioned trials. Comparisons of trial recruitment targets with estimated feasible recruitment numbers. RESULTS: Analysis of trial registration data for COVID-19 treatment studies enrolling in England showed that by 12 July 2020, 29 142 participants were needed. In the observational study, 430 (20.7%) proceeded to randomisation. 82 (3.9%) declined participation, 699 (33.6%) were excluded on clinical grounds, 363 (17.4%) were medically fit for discharge and 153 (7.3%) were receiving palliative care. With 111 037 people hospitalised with COVID-19 in England by 12 July 2020, we determine that 22 985 people were potentially suitable for trial enrolment. We estimate a UK hospitalisation rate of 2.38%, and that another 1.25 million infections would be required to meet recruitment targets of ongoing trials. CONCLUSIONS: Feasible recruitment rates, study design and proliferation of trials can limit the number, and size, that will successfully complete recruitment. We consider that fewer, more appropriately designed trials, prioritising cooperation between centres would maximise productivity in a further wave.


Asunto(s)
Investigación Biomédica , Infecciones por Coronavirus , Pandemias , Selección de Paciente , Neumonía Viral , Ensayos Clínicos Controlados Aleatorios como Asunto , Betacoronavirus/aislamiento & purificación , Investigación Biomédica/organización & administración , Investigación Biomédica/estadística & datos numéricos , Infecciones por Coronavirus/epidemiología , Infecciones por Coronavirus/terapia , Determinación de la Elegibilidad , Femenino , Accesibilidad a los Servicios de Salud/estadística & datos numéricos , Hospitalización/estadística & datos numéricos , Humanos , Masculino , Persona de Mediana Edad , Neumonía Viral/epidemiología , Neumonía Viral/terapia , Estudios Prospectivos , Ensayos Clínicos Controlados Aleatorios como Asunto/métodos , Ensayos Clínicos Controlados Aleatorios como Asunto/estadística & datos numéricos , Sistema de Registros/estadística & datos numéricos , Reino Unido
19.
BMC Pregnancy Childbirth ; 20(1): 587, 2020 Oct 06.
Artículo en Inglés | MEDLINE | ID: mdl-33023500

RESUMEN

BACKGROUND: There are no published cases of tonic-clonic seizures and posterior bilateral blindness during pregnancy and Severe Acute Respiratory Syndrome (SARS) Coronavirus (COV) 2 (SARS-COV-2) infection. We do not just face new and unknown manifestations, but also how different patient groups are affected by SARS-COV-2 infection, such as pregnant women. Coronavirus Disease 2019 (COVID-19), preeclampsia, eclampsia and posterior reversible leukoencephalopathy share endothelium damage and similar pathophysiology. CASE PRESENTATION: A 35-year-old pregnant woman was admitted for tonic-clonic seizures and SARS-COV-2 infection. She had a normal pregnancy control and no other symptoms before tonic-clonic seizures development. After a Caesarean section (C-section) she developed high blood pressure, and we initiated antihypertensive treatment with labetalol, amlodipine and captopril. Few hours later she developed symptoms of cortical blindness that resolved in 72 h with normal brain computed tomography (CT) angiography. CONCLUSION: The authors conclude that SARS COV-2 infection could promote brain endothelial damage and facilitate neurological complications during pregnancy.


Asunto(s)
Antihipertensivos/administración & dosificación , Betacoronavirus/aislamiento & purificación , Ceguera Cortical , Cesárea/métodos , Infecciones por Coronavirus , Eclampsia , Fibrinolíticos/administración & dosificación , Pandemias , Neumonía Viral , Complicaciones Infecciosas del Embarazo , Convulsiones , Adulto , Ceguera Cortical/diagnóstico , Ceguera Cortical/virología , Encéfalo/diagnóstico por imagen , Angiografía por Tomografía Computarizada/métodos , Infecciones por Coronavirus/diagnóstico , Infecciones por Coronavirus/fisiopatología , Diagnóstico Diferencial , Eclampsia/diagnóstico , Eclampsia/terapia , Eclampsia/virología , Femenino , Humanos , Examen Neurológico/métodos , Neumonía Viral/diagnóstico , Neumonía Viral/fisiopatología , Embarazo , Complicaciones Infecciosas del Embarazo/diagnóstico , Complicaciones Infecciosas del Embarazo/etiología , Complicaciones Infecciosas del Embarazo/fisiopatología , Resultado del Embarazo , Convulsiones/diagnóstico , Convulsiones/etiología , Convulsiones/terapia , Tomografía Computarizada por Rayos X/métodos , Resultado del Tratamiento
20.
Trials ; 21(1): 828, 2020 Oct 06.
Artículo en Inglés | MEDLINE | ID: mdl-33023671

RESUMEN

OBJECTIVES: Primary objectives • To assess the time from randomisation until an improvement within 84 days defined as two points on a seven point ordinal scale or live discharge from the hospital in high-risk patients (group 1 to group 4) with SARS-CoV-2 infection requiring hospital admission by infusion of plasma from subjects after convalescence of SARS-CoV-2 infection or standard of care. Secondary objectives • To assess overall survival, and the overall survival rate at 28 56 and 84 days. • To assess SARS-CoV-2 viral clearance and load as well as antibody titres. • To assess the percentage of patients that required mechanical ventilation. • To assess time from randomisation until discharge. TRIAL DESIGN: Randomised, open-label, multicenter phase II trial, designed to assess the clinical outcome of SARS-CoV-2 disease in high-risk patients (group 1 to group 4) following treatment with anti-SARS-CoV-2 convalescent plasma or standard of care. PARTICIPANTS: High-risk patients >18 years of age hospitalized with SARS-CoV-2 infection in 10-15 university medical centres will be included. High-risk is defined as SARS-CoV-2 positive infection with Oxygen saturation at ≤ 94% at ambient air with additional risk features as categorised in 4 groups: • Group 1, pre-existing or concurrent hematological malignancy and/or active cancer therapy (incl. chemotherapy, radiotherapy, surgery) within the last 24 months or less. • Group 2, chronic immunosuppression not meeting the criteria of group 1. • Group 3, age ≥ 50 - 75 years meeting neither the criteria of group 1 nor group 2 and at least one of these criteria: Lymphopenia < 0.8 x G/l and/or D-dimer > 1µg/mL. • Group 4, age ≥ 75 years meeting neither the criteria of group 1 nor group 2. Observation time for all patients is expected to be at least 3 months after entry into the study. Patients receive convalescent plasma for two days (day 1 and day 2) or standard of care. For patients in the standard arm, cross over is allowed from day 10 in case of not improving or worsening clinical condition. Nose/throat swabs for determination of viral load are collected at day 0 and day 1 (before first CP administration) and subsequently at day 2, 3, 5, 7, 10, 14, 28 or until discharge. Serum for SARS-Cov-2 diagnostic is collected at baseline and subsequently at day 3, 7, 14 and once during the follow-up period (between day 35 and day 84). There is a regular follow-up of 3 months. All discharged patients are followed by regular phone calls. All visits, time points and study assessments are summarized in the Trial Schedule (see full protocol Table 1). All participating trial sites will be supplied with study specific visit worksheets that list all assessments and procedures to be completed at each visit. All findings including clinical and laboratory data are documented by the investigator or an authorized member of the study team in the patient's medical record and in the electronic case report forms (eCRFs). INTERVENTION AND COMPARATOR: This trial will analyze the effects of convalescent plasma from recovered subjects with SARS-CoV-2 antibodies in high-risk patients with SARS-CoV-2 infection. Patients at high risk for a poor outcome due to underlying disease, age or condition as listed above are eligible for enrollment. In addition, eligible patients have a confirmed SARS-CoV-2 infection and O2 saturation ≤ 94% while breathing ambient air. Patients are randomised to receive (experimental arm) or not receive (standard arm) convalescent plasma in two bags (238 - 337 ml plasma each) from different donors (day 1, day 2). A cross over from the standard arm into the experimental arm is possible after day 10 in case of not improving or worsening clinical condition. MAIN OUTCOMES: Primary endpoints: The main purpose of the study is to assess the time from randomisation until an improvement within 84 days defined as two points on a seven-point ordinal scale or live discharge from the hospital in high-risk patients (group 1 to group 4) with SARS-CoV-2 infection requiring hospital admission by infusion of plasma from subjects after convalescence of a SARS-CoV-2 infection or standard of care. Secondary endpoints: • Overall survival, defined as the time from randomisation until death from any cause 28-day, 56-day and 84-day overall survival rates. • SARS-CoV-2 viral clearance and load as well as antibody titres. • Requirement mechanical ventilation at any time during hospital stay (yes/no). • Time until discharge from randomisation. • Viral load, changes in antibody titers and cytokine profiles are analysed in an exploratory manner using paired non-parametric tests (before - after treatment). RANDOMISATION: Upon confirmation of eligibility (patients must meet all inclusion criteria and must not meet exclusion criteria described in section 5.3 and 5.4 of the full protocol), the clinical site must contact a centralized internet randomization system ( https://randomizer.at/ ). Patients are randomized using block randomisation to one of the two arms, experimental arm or standard arm, in a 1:1 ratio considering a stratification according to the 4 risk groups (see Participants). BLINDING (MASKING): The study is open-label, no blinding will be performed. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): A total number of 174 patients is required for the entire trial, n=87 per group. TRIAL STATUS: Protocol version 1.2 dated 09/07/2020. A recruitment period of approximately 9 months and an overall study duration of approximately 12 months is anticipated. Recruitment of patients starts in the third quarter of 2020. The study duration of an individual patient is planned to be 3 months. After finishing all study-relevant procedures, therapy, and follow-up period, the patient is followed in terms of routine care and treated if necessary. Total trial duration: 18 months Duration of the clinical phase: 12 months First patient first visit (FPFV): 3rd Quarter 2020 Last patient first visit (LPFV): 2nd Quarter 2021 Last patient last visit (LPLV): 3rd Quarter 2021 Trial Report completed: 4th Quarter 2021 TRIAL REGISTRATION: EudraCT Number: 2020-001632-10, https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001632-10/DE , registered on 04/04/2020. FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2). The eCRF is attached (Additional file 3).


Asunto(s)
Anticuerpos Antivirales/sangre , Betacoronavirus , Infecciones por Coronavirus , Pandemias , Plasma/inmunología , Neumonía Viral , Anciano , Betacoronavirus/inmunología , Betacoronavirus/aislamiento & purificación , Ensayos Clínicos Fase II como Asunto , Convalecencia , Infecciones por Coronavirus/diagnóstico , Infecciones por Coronavirus/inmunología , Infecciones por Coronavirus/terapia , Femenino , Humanos , Inmunización Pasiva/métodos , Masculino , Persona de Mediana Edad , Monitoreo Fisiológico/métodos , Estudios Multicéntricos como Asunto , Neumonía Viral/diagnóstico , Neumonía Viral/inmunología , Neumonía Viral/terapia , Ensayos Clínicos Controlados Aleatorios como Asunto , Ajuste de Riesgo , Índice de Severidad de la Enfermedad
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