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1.
World Journal of Emergency Surgery ; 15(1):43-43, 2020.
Artículo | COVIDWHO | ID: covidwho-621542

RESUMEN

Since its first documentation, a novel coronavirus (SARS-CoV-2) infection has emerged worldwide, with the consequent declaration of a pandemic disease (COVID-19) Severe forms of acute respiratory failure can develop In addition, SARS-CoV-2 may affect organs other than the lung, such as the liver, with frequent onset of late cholestasis We here report the histological findings of a COVID-19 patient, affected by a tardive complication of acute ischemic and gangrenous cholecystitis with a perforated and relaxed gallbladder needing urgent surgery A 59-year-old Caucasian male, affected by acute respiratory failure secondary to SARS-CoV-2 infection was admitted to our intensive care unit (ICU) Due to the severity of the disease, invasive mechanical ventilation was instituted and SARS-CoV-2 treatment (azithromycin 250 mg once-daily and hydroxychloroquine 200 mg trice-daily) started Enoxaparin 8000 IU twice-daily was also administered subcutaneously At day 8 of ICU admission, the clinical condition improved and patient was extubated At day 32, patient revealed abdominal pain without signs of peritonism at examination, with increased inflammatory and cholestasis indexes at blood tests At a first abdominal CT scan, perihepatic effusion and a relaxed gallbladder with dense content were detected The surgeon decided to wait and see the evolution of clinical conditions The day after, conditions further worsened and a laparotomic cholecystectomy was performed A relaxed and perforated ischemic gangrenous gallbladder, with a local tissue inflammation and perihepatic fluid, was intraoperatively met The gallbladder and a sample of omentum, adherent to the gallbladder, were also sent for histological examination Hematoxylin-eosin-stained slides display inflammatory infiltration and endoluminal obliteration of vessels, with wall breakthrough, hemorrhagic infarction, and nerve hypertrophy of the gallbladder The mucosa of the gallbladder appears also atrophic Omentum vessels also appear largely thrombosed Immunohistochemistry demonstrates an endothelial overexpression of medium-size vessels (anti-CD31), while not in micro-vessels, with a remarkable activity of macrophages (anti-CD68) and T helper lymphocytes (anti-CD4) against gallbladder vessels All these findings define a histological diagnosis of vasculitis of the gallbladder Ischemic gangrenous cholecystitis can be a tardive complication of COVID-19, and it is characterized by a dysregulated host inflammatory response and thrombosis of medium-size vessels

2.
Trials ; 21(1):604-604, 2020.
Artículo | COVIDWHO | ID: covidwho-621541

RESUMEN

To determine whether chemoprophylaxis with hydroxychloroquine versus placebo increases time to contracting coronavirus disease 2019 (COVID-19) in frontline healthcare workers Double-blind, multi-centre, 2-arm (3:3:2 ratio) randomised placebo-controlled trial National Health Service (NHS) workers who have direct patient contact delivering care to patients with COVID-19 Participants in the trial will be recruited from a number of NHS hospitals directly caring for patients with COVID-19 To be included in the trial the participant MUST: The presence of any of the following will mean participants are ineligible: Interventions being evaluated are: The maximum treatment period is approximately 13 weeks per participant Hydroxychloroquine-identical matched placebo tablets will ensure that all participants are taking the same number and dosing regimen of tablets across the three trial arms There is no variation in the dose of hydroxychloroquine by weight The dosing regimen for the three arms of the study (A, B, C) are described in further detail below Arm A: Active Hydroxychloroquine (– daily dosing and placebo-matched hydroxychloroquine - weekly dosing) Form: Tablets Route: Oral Dose and Frequency: Active hydroxychloroquine: Matched Placebo hydroxychloroquine: Arm B: Active Hydroxychloroquine (- weekly dosing and placebo matched hydroxychloroquine – daily dosing ) Form: Tablets Route: Oral Dose and Frequency: Active hydroxychloroquine: Matched Placebo hydroxychloroquine: Arm C: Matched placebo Hydroxychloroquine (- daily dosing and matched placebo hydroxychloroquine - weekly dosing ) Form: Table Route: Oral Frequency: Matched placebo hydroxychloroquine - daily dosing: Matched placebo hydroxychloroquine – weekly dosing: A schematic of the dosing schedule can be found in the full study protocol (Additional File 1) Time to diagnosis of positive COVID-19 disease (defined by record of date of symptoms onset and confirmed by laboratory test) Participants will be randomised to either hydroxychloroquine dosed daily with weekly placebo, HCQ dosed weekly with daily placebo, or placebo dosed daily and weekly Randomisation will be in a 3:3:2 ratio [hydroxychloroquine-(daily), hydroxychloroquine-(weekly), placebo], using stratified block randomisation Random block sizes will be used, and stratification will be by study site Participants and trial investigators consenting participants, delivering trial assessments and procedures will be blinded to intervention A sufficient number of participants will be enrolled so that approximately 1000 participants in total will have data suitable for the primary statistical analysis It is anticipated that approximately 1,200 participants will need to be enrolled in total, to allow for a 20% dropout over the period of the trial This would result in approximately 450:450:300 participants randomised to hydroxychloroquine daily, hydroxychloroquine weekly+daily matched placebo or matched-placebo daily and weekly V 1 0, 7th April 2020 EU Clinical Trials Register EudraCT Number: 2020-001331-26 Date of registration: 14th April 2020 Trial registered before first participant enrolment Trial site is Cambridge University Hospitals NHS Foundation Trust Recruitment started on 11th May 2020 It is anticipated that the trial will run for 12 months The recruitment end date cannot yet be accurately predicted The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1) In the interest of 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)

3.
Trials ; 21(1):607-607, 2020.
Artículo | COVIDWHO | ID: covidwho-621540

RESUMEN

The primary objectives of the study are: 1 To assess the effect of hydroxychloroquine (HCQ) in reducing SARS-CoV-2 viral shedding by PCR in infected pregnant women with mild symptoms 2 To assess the efficacy of HCQ to prevent SARS-CoV-2 infection in pregnant women in contact with an infected or suspected case 3 To evaluate the effect of HCQ in preventing the development of the COVID-19 disease in asymptomatic SARS-CoV-2-infected pregnant women The secondary objectives are: 1 To determine the effect of HCQ on the clinical course and duration of the COVID-19 disease in SARS-CoV-2-infected pregnant women 2 To determine the impact of HCQ on the risk of hospitalization and mortality of SARS-CoV-2-infected pregnant women 3 To assess the safety and tolerability of HCQ in pregnant women 4 To describe the clinical presentation of SARS-CoV-2 infection during pregnancy 5 To describe the effects of maternal SARS-CoV-2 infection on pregnancy and perinatal outcomes by treatment group 6 To determine the risk of vertical transmission (intra-utero and intra-partum) of SARS-CoV-2 Randomized double-blind placebo-controlled two-arm multicentre clinical trial to evaluate the safety and efficacy of HCQ to prevent and/or minimize SARS-CoV-2 infection during pregnancy Participants will be randomized to receive a 14-day oral treatment course of HCQ or placebo, ratio 1:1 Study population: pregnant women undergoing routine prenatal follow up or attending emergency units at the participating hospitals who report either symptoms/signs suggestive of COVID-19 disease or close contact with a suspected or confirmed COVID-19 case Inclusion criteria Women will be invited to participate in the trial and sign an informed consent if they meet the following inclusion criteria • Presenting with fever (≥37 5°C) and/or one mild symptom suggestive of COVID-19 disease (cough, dyspnoea, chills, odynophagia, diarrhoea, muscle pain, anosmia, dysgeusia, headache) OR being contact* of a SARS-CoV-2 confirmed or suspected case in the past 14 days • More than 12 weeks of gestation (dated by ultrasonography) • Agreement to deliver in the study hospitals Exclusion criteria • Known hypersensitivity to HCQ or other 4-amonoquinoline compounds • History of retinopathy of any aetiology • Concomitant use of digoxin, cyclosporine, cimetidine • Known liver disease • Clinical history of cardiac pathology including known long QT syndrome • Unable to cooperate with the requirements of the study • Participating in other intervention studies • Delivery onset (characterized by painful uterine contractions and variable changes of the cervix, including some degree of effacement and slower progression of dilatation up to 5 cm for first and subsequent labours) The study participants will be stratified by clinical presentation and SARS-CoV-2 PCR results Assignment of participants to study groups will be as follows: • SARS-CoV-2-PCR confirmed, infected pregnant women: a symptomatic (n=100) b asymptomatic (n=100) • SARS-CoV-2 PCR negative pregnant women in contact* with a SARS-CoV-2-infected confirmed or suspected case (n=514) *The ECDC definition of close contact will be followed The trial will be conducted in five hospitals in Spain: Hospital Clínic of Barcelona, Hospital Sant Joan de Déu and Hospital de la Santa Creu i Sant Pau, in Barcelona, and HM Puerta del Sur and Hospital Universitario de Torrejón, in Madrid Participants will be randomized to HCQ (400 mg/day for three days, followed by 200 mg/day for 11 days) or placebo (2 tablets for three days, followed by one tablet for 11 days) The primary outcome is the number of PCR-confirmed infected pregnant women assessed from collected nasopharyngeal and oropharyngeal swabs at day 21 after treatment start (one week after treatment is completed) Allocation of participants to study arms will be done centrally by the trial’s Sponsor (the Barcelona Institute for Global Health, ISGlobal) by block randomization This method will ensure balanced allocation to both arms The electronic CRF will automatically assign a study number to each participant, depending on her study group and recruitment site Each number will be related to a treatment number, which assigns them to one of the study arms Participants, caregivers, investigators and those assessing the outcomes will be blinded to group assignment Study tablets (HCQ and placebo) will be identically packaged in small opaque bottles This study requires 200 SARS-CoV-2 infected and 514 contact pregnant women, randomised 1:1 with 100 and 227 respectively in each study arm Protocol version 1 0, from May 8th, 2020 Recruitment is ongoing (first patient recruited the 19th May 2020 and recruitment end anticipated by December 2020) EudraCT number: 2020-001587-29, registered 2 April 2020 Clinicaltrials gov identifier: NCT04410562 , retrospectively registered 1 June 2020 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

4.
Trials ; 21(1):608-608, 2020.
Artículo | COVIDWHO | ID: covidwho-621539

RESUMEN

Wound complications following midline laparotomies are common and the main source of postoperative morbidity including superficial or deep wound infection, skin dehiscence, fascia dehiscence, and incisional hernia Abdominal closure complications are strongly associated with suture technique and material, in addition to other factors related to the patient and type of surgery performed The traditional technique is to place the fascia sutures 1 cm apart and at least 1 cm away from the fascia edge A Swedish study described a new technique of placing the sutures 5 mm apart and 5 mm away from the fascia edge, resulting in lower rates of abdominal wound complications This study has a number of limitations There is a need for improved quality evidence to convince the surgical community to change the closure technique of abdominal wounds aiming to reduce morbidity, which is exemplified in incisional hernias and other various postop complications This is a 1:1 randomized, controlled, patient- and assessor-blinded, parallel design, superiority trial, with a primary endpoint of incisional hernia at 1 year The study will be conducted at AUBMC over a 3-year period Patients planned for a non-emergent midline laparotomy for general surgery or vascular procedure will be randomized to either fascia closure technique In order to detect a drop of 12% in the incidence of incisional hernia, with 80% power and an alpha of 0 05, we will need to recruit 114 patients per arm After adjusting for loss to follow-up, target recruitment is 274 subjects We will compare both arms for the primary, secondary, and exploratory outcomes, using chi-square or t test as appropriate Univariate and multivariate logistic regression will be done This trial will assess postop complications following abdominal midline wound closures via two different suturing techniques This trial will generate evidence-based conclusions that will allow surgeons to assess the role of a new abdominal closure technique in decreasing short- and long-term postoperative complications, for a commonly performed procedure ClinicalTrials gov NCT03527433 Registered on 17 May 2018 before starting participant enrollment

6.
Sports Medicine ; 2020.
Artículo | COVIDWHO | ID: covidwho-621537

RESUMEN

Recent years in Europe have generated situations requiring the European Union to take extra-coordinated action in the field of asylum policy The sudden and growing influx of refugees to Europe in 2015 and 2016 has caused the collapse of the previous common European asylum system The European Union has taken a number of measures to resolve this crisis situation When the situation seemed to be under control , a new challenge emerged in early 2020 The first COVID-19 infectious disease case was reported in Europe, and on 13 March 2020 the WHO reported that Europe had become the epicentre of the coronavirus pandemic The measures taken by individual countries and the European Union to limit the spread of the virus have had a significant impact on many spheres of state and individual functioning, including the situation of persons seeking international protection This publication consists of three parts The first part discusses actions taken by the European Union in the face of the migration and refugee crisis that emerged in 2015 and 2016 The second part presents one of the limitations introduced in connection with preventing the spread of COVID-19, which has a huge impact on persons wishing to seek international protection, i e , changes in the regime of crossing borders and entering the territory of particular countries The third one points out selected problems experienced by persons seeking protection who already stay in the territory of EU Member States

7.
SN Comprehensive Clinical Medicine ; 2020.
Artículo | COVIDWHO | ID: covidwho-621536

RESUMEN

SARS-CoV-2 was reported for the first time in China on December 31, 2019, as the cause of some pneumonia cases characterized by fever, cough, dyspnea, myalgia, and fatigue Here, we present our approach to a 54-year-old male patient who had coronary artery bypass (CABG) surgery diagnosed as high probability coronavirus disease 2019 (COVID-19) in early postoperative period

8.
Notfall + Rettungsmedizin ; 2020.
Artículo | COVIDWHO | ID: covidwho-621531

RESUMEN

Recent years in Europe have generated situations requiring the European Union to take extra-coordinated action in the field of asylum policy The sudden and growing influx of refugees to Europe in 2015 and 2016 has caused the collapse of the previous common European asylum system The European Union has taken a number of measures to resolve this crisis situation When the situation seemed to be under control , a new challenge emerged in early 2020 The first COVID-19 infectious disease case was reported in Europe, and on 13 March 2020 the WHO reported that Europe had become the epicentre of the coronavirus pandemic The measures taken by individual countries and the European Union to limit the spread of the virus have had a significant impact on many spheres of state and individual functioning, including the situation of persons seeking international protection This publication consists of three parts The first part discusses actions taken by the European Union in the face of the migration and refugee crisis that emerged in 2015 and 2016 The second part presents one of the limitations introduced in connection with preventing the spread of COVID-19, which has a huge impact on persons wishing to seek international protection, i e , changes in the regime of crossing borders and entering the territory of particular countries The third one points out selected problems experienced by persons seeking protection who already stay in the territory of EU Member States

9.
Neurological Sciences ; 2020.
Artículo | COVIDWHO | ID: covidwho-621530

RESUMEN

Neurological manifestations can occur during coronavirus disease 19 (COVID-19) Several pathogenic mechanisms have been hypothesized, without conclusive results In this study, we evaluated the most frequent neurological symptoms in a cohort of hospitalized COVID-19 patients, and also investigated the possible relationship between plasmatic inflammatory indices and olfactory disorders (ODs) and between muscle pain and creatine kinase (CK) We consecutively enrolled hospitalized COVID-19 patients A structured questionnaire concerning typical and neurological symptoms, focusing on headache, dizziness, ODs, taste disorders (TDs), and muscle pain, was administrated by telephone interviews Common neurological symptoms were reported in the early phase of the disease, with a median onset ranging from 1 to 3 days Headache showed tension-type features and was more frequently associated with a history of headache Patients with ODs less frequently needed oxygen therapy Inflammatory indices did not significantly differ between patients with and without ODs Muscle pain did not show any association with CK level but was more frequently associated with arthralgia and headache In our cohort, ODs were an early symptom of COVID-19, more frequently reported by patients with milder forms of disease Headache in association with arthralgia and muscle pain seems to reflect the common symptoms of the flu-like syndrome, and not COVID-19 infection-specific

10.
Neurological Sciences ; 2020.
Artículo | COVIDWHO | ID: covidwho-621529
11.
Neurological Sciences ; 2020.
Artículo | COVIDWHO | ID: covidwho-621528

RESUMEN

We assessed the prevalence and impact of COVID-19 among multiple sclerosis (MS) patients across Europe by leveraging participant data collected as part of the ongoing EU IMI2 RADAR-CNS major programme aimed at finding new ways of monitoring neurological disorders using wearable devices and smartphone technology In the present study, 399 patients of RADAR-MS have been included (mean age 43 9 years, 60 7% females) with 87/399 patients (21 8%) reporting major symptoms suggestive of COVID-19 A trend for an increased risk of COVID-19 symptoms under alemtuzumab and cladribine treatments in comparison to injectables was observed Remote monitoring technologies may support health authorities in monitoring and containing the ongoing pandemic

12.
Medizinische Klinik - Intensivmedizin und Notfallmedizin ; 2020.
Artículo | COVIDWHO | ID: covidwho-621526

RESUMEN

Recent years in Europe have generated situations requiring the European Union to take extra-coordinated action in the field of asylum policy The sudden and growing influx of refugees to Europe in 2015 and 2016 has caused the collapse of the previous common European asylum system The European Union has taken a number of measures to resolve this crisis situation When the situation seemed to be under control , a new challenge emerged in early 2020 The first COVID-19 infectious disease case was reported in Europe, and on 13 March 2020 the WHO reported that Europe had become the epicentre of the coronavirus pandemic The measures taken by individual countries and the European Union to limit the spread of the virus have had a significant impact on many spheres of state and individual functioning, including the situation of persons seeking international protection This publication consists of three parts The first part discusses actions taken by the European Union in the face of the migration and refugee crisis that emerged in 2015 and 2016 The second part presents one of the limitations introduced in connection with preventing the spread of COVID-19, which has a huge impact on persons wishing to seek international protection, i e , changes in the regime of crossing borders and entering the territory of particular countries The third one points out selected problems experienced by persons seeking protection who already stay in the territory of EU Member States

13.
Journal of Urban Health ; 2020.
Artículo | COVIDWHO | ID: covidwho-621524

RESUMEN

Several types of resources coexist for coordinated action and systemic responses to this extraordinary situation--administrative, behavioural, financial, health care, legal and medical resources--that have been used at different geo-political levels, sometimes in an uncoordinated fashion of ‘winner takes all’

15.
Journal of Thrombosis and Thrombolysis ; 2020.
Artículo | COVIDWHO | ID: covidwho-621522

RESUMEN

COVID-19 is associated with a variety of clinical complications including coagulopathy, which frequently results in venous thromboembolism (VTE) Retrospective analyses reported a markedly increased rate of VTEs in COVID-19 However, most recent studies on coagulopathy in COVID-19 were only focused on critically ill patients, and without suitable control groups We aimed to evaluate the rate of VTEs in an all-comers cohort with suspected COVID-19 during a 30-days follow-up period We also studied the level of D-dimers and their association with the course of disease In our prospective single-center study (DRKS00021206, 03/30/2020), we analyzed 190 patients with suspected COVID-19 admitted to the emergency department between March and April 2020 Forty-nine patients were SARS-CoV-2 positive (25 8%) The 141 SARS-CoV-2-negative patients served as control group After completion of a 30-days follow-up, VTE was diagnosed in 3 patients of the SARS-CoV-2-positive group (6 1%, amongst these 2 ICU cases) versus 5 patients in the SARS-CoV-2-negative group (3 5%), however the difference was not statistically significant (p = 0 427) 30-days mortality was similar in both groups (6 1% vs 5%, p = 0 720) Disease severity correlated with the maximum level of D-dimers during follow-up in COVID-19 The rate of VTE was numerically higher in SARS-CoV-2 positive all-comers presenting with suspected COVID-19 as compared to well-matched controls suffering from similar symptoms VTEs in the COVID-19 group predominantly occurred in ICU courses The maximum level of D-dimers during follow-up was associated with disease severity in COVID-19, whereas the level of D-dimers at admission was not

16.
Journal of Thrombosis and Thrombolysis ; 2020.
Artículo | COVIDWHO | ID: covidwho-621521

RESUMEN

Recent years in Europe have generated situations requiring the European Union to take extra-coordinated action in the field of asylum policy The sudden and growing influx of refugees to Europe in 2015 and 2016 has caused the collapse of the previous common European asylum system The European Union has taken a number of measures to resolve this crisis situation When the situation seemed to be under control , a new challenge emerged in early 2020 The first COVID-19 infectious disease case was reported in Europe, and on 13 March 2020 the WHO reported that Europe had become the epicentre of the coronavirus pandemic The measures taken by individual countries and the European Union to limit the spread of the virus have had a significant impact on many spheres of state and individual functioning, including the situation of persons seeking international protection This publication consists of three parts The first part discusses actions taken by the European Union in the face of the migration and refugee crisis that emerged in 2015 and 2016 The second part presents one of the limitations introduced in connection with preventing the spread of COVID-19, which has a huge impact on persons wishing to seek international protection, i e , changes in the regime of crossing borders and entering the territory of particular countries The third one points out selected problems experienced by persons seeking protection who already stay in the territory of EU Member States

17.
Journal of Public Health Policy ; 2020.
Artículo | COVIDWHO | ID: covidwho-621520

RESUMEN

Recent years in Europe have generated situations requiring the European Union to take extra-coordinated action in the field of asylum policy The sudden and growing influx of refugees to Europe in 2015 and 2016 has caused the collapse of the previous common European asylum system The European Union has taken a number of measures to resolve this crisis situation When the situation seemed to be under control , a new challenge emerged in early 2020 The first COVID-19 infectious disease case was reported in Europe, and on 13 March 2020 the WHO reported that Europe had become the epicentre of the coronavirus pandemic The measures taken by individual countries and the European Union to limit the spread of the virus have had a significant impact on many spheres of state and individual functioning, including the situation of persons seeking international protection This publication consists of three parts The first part discusses actions taken by the European Union in the face of the migration and refugee crisis that emerged in 2015 and 2016 The second part presents one of the limitations introduced in connection with preventing the spread of COVID-19, which has a huge impact on persons wishing to seek international protection, i e , changes in the regime of crossing borders and entering the territory of particular countries The third one points out selected problems experienced by persons seeking protection who already stay in the territory of EU Member States

19.
Journal of International Business Studies ; 2020.
Artículo | COVIDWHO | ID: covidwho-621518

RESUMEN

Recent years in Europe have generated situations requiring the European Union to take extra-coordinated action in the field of asylum policy The sudden and growing influx of refugees to Europe in 2015 and 2016 has caused the collapse of the previous common European asylum system The European Union has taken a number of measures to resolve this crisis situation When the situation seemed to be under control , a new challenge emerged in early 2020 The first COVID-19 infectious disease case was reported in Europe, and on 13 March 2020 the WHO reported that Europe had become the epicentre of the coronavirus pandemic The measures taken by individual countries and the European Union to limit the spread of the virus have had a significant impact on many spheres of state and individual functioning, including the situation of persons seeking international protection This publication consists of three parts The first part discusses actions taken by the European Union in the face of the migration and refugee crisis that emerged in 2015 and 2016 The second part presents one of the limitations introduced in connection with preventing the spread of COVID-19, which has a huge impact on persons wishing to seek international protection, i e , changes in the regime of crossing borders and entering the territory of particular countries The third one points out selected problems experienced by persons seeking protection who already stay in the territory of EU Member States

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