Knowledge and Beliefs about COVID-19 among migrant women: A qualitative study. (preprint)

COVID-19 has had a significant impact on the Spanish population, as well as on Social Determinants of Health among which sex, sex/being a woman and being a migrant stand out. The goal of this study was to describe the beliefs and knowledge that migrant women from a racialised neighbourhood had about COVID-19 during the COVID-19 pandemic. To do this, a qualitative study was carried out in a particular neighbourhood in Mallorca. The analysis used a hybrid-focus with a coding tree that was open to other emerging categories, segmented as per the variables of having contracted COVID-19 or not having contracted the virus. 20 adult migrant women were interviewed and 7 categories emerged from their discourses: (1) regarding knowledge of the virus; (2) sources of information; (3) incorrect beliefs about the virus and use of home remedies; (4) economic difficulties when complying with prevention measures; (5) general and specific knowledge about diagnostic testing; (6) regarding difficulties on isolating themselves; and (7) vaccination acceptance. We found differences in favour of women with an academic background. These women were more empowered, being more critical of the information they were given and able to look for resources in the community, Making sex inequalities more visible—both existing and emerging— will help to generate effective public policies that promote equality in healthcare and social spheres

A comparison of four self-controlled study designs in an analysis of COVID-19 vaccines and myocarditis using five European databases (preprint)

IntroductionThe aim of this study was to assess the possible extent of bias due to violation of a core assumption (event-dependent exposures) when using self-controlled designs to analyse the association between COVID-19 vaccines and myocarditis. MethodsWe used data from five European databases (Spain: BIFAP, FISABIO VID, and SIDIAP; Italy: ARS-Tuscany; England: CPRD Aurum) converted to the ConcePTION Common Data Model. Individuals who experienced both myocarditis and were vaccinated against COVID-19 between 1 September 2020 and the end of data availability in each country were included. We compared a self-controlled risk interval study (SCRI) using a pre-vaccination control window, an SCRI using a post-vaccination control window, a standard SCCS and an extension of the SCCS designed to handle violations of the assumption of event-dependent exposures. ResultsWe included 1,757 cases of myocarditis. In unadjusted analyses, agreement between study designs varied by vaccine brand. There was good agreement between all designs for AstraZeneca and Pfizer, but for Moderna we found harmful incidence rate ratios (IRR) using the standard and extended SCCS (standard SCCS: IRR = 3.12, 95%CI = 1.53 - 6.40; extended SCCS: IRR = 2.43, 95%CI = 1.11 - 5.33) compared with no association with the SCRIs (SCRI-pre: IRR = 0.60, 95%CI = 0.27 - 1.33; SCRI-post: IRR = 0.86, 95%CI = 0.34 - 2.19), although confidence intervals were wide. There was very good agreement between all designs for the unadjusted second dose analyses, confirming the known harmful association between the second dose of Moderna and Pfizer vaccines and myocarditis. ConclusionsIn the context of the known association between COVID-19 vaccines and myocarditis, we have demonstrated that two forms of SCRI and two forms of SCCS led to largely comparable results, possibly because of limited violation of the assumption of event-dependent exposures.

The evaluation of in vitro antichagasic and anti-SARS-CoV-2 potential of inclusion complexes of ß- and methyl-ß-cyclodextrin with naphthoquinone.

The compound 3a,10b-dihydro-1H-cyclopenta[b]naphtho[2,3-d]furan-5,10-dione (IVS320) is a naphthoquinone with antifungal and antichagasic potential, which however has low aqueous solubility. To increase bioavailability, inclusion complexes with ß-cyclodextrin (ßCD) and methyl-ß-cyclodextrin (MßCD) were prepared by physical mixture (PM), kneading (KN) and rotary evaporation (RE), and their in vitro anti-SARS-CoV-2 and antichagasic potential was assessed. The formation of inclusion complexes led to a change in the physicochemical characteristics compared to IVS320 alone as well as a decrease in crystallinity degree that reached 74.44% for the IVS320-MßCD one prepared by RE. The IVS320 and IVS320-MßCD/RE system exhibited anti-SARS-CoV-2 activity, showing half maximal effective concentrations (EC50) of 0.47 and 1.22 µg/mL, respectively. Molecular docking simulation suggested IVS320 ability to interact with the SARS-CoV-2 viral protein. Finally, the highest antichagasic activity, expressed as percentage of Tripanosoma cruzi growth inhibition, was observed with IVS320-ßCD/KN (70%) and IVS320-MßCD/PM (72%), while IVS320 alone exhibited only approximately 48% inhibition at the highest concentration (100 µg/mL).

Cohort monitoring of 29 Adverse Events of Special Interest prior to and after COVID-19 vaccination in four large European electronic healthcare data sources (preprint)

Setting Primary and/or secondary health care data from four European countries: Italy, the Netherlands, the United Kingdom, Spain Participants Individuals with complete data for the year preceding enrollment or those born at the start of observation time. The cohort comprised 25,720,158 subjects. Interventions First and second dose of Pfizer, AstraZeneca, Moderna, or Janssen COVID-19 vaccine. Main outcome measures 29 adverse events of special interest (AESI): acute aseptic arthritis, acute coronary artery disease, acute disseminated encephalomyelitis (ADEM), acute kidney injury, acute liver injury, acute respiratory distress syndrome, anaphylaxis, anosmia or ageusia, arrhythmia, Bells’ palsy, chilblain-like lesions death, erythema multiforme, Guillain Barré Syndrome (GBS), generalized convulsion, haemorrhagic stroke, heart failure, ischemic stroke, meningoencephalitis, microangiopathy, multisystem inflammatory syndrome, myo/pericarditis, myocarditis, narcolepsy, single organ cutaneous vasculitis (SOCV), stress cardiomyopathy, thrombocytopenia, thrombotic thrombocytopenia syndrome (TTS) venous thromboembolism (VTE) Results 12,117,458 individuals received at least a first dose of COVID-19 vaccine: 54% with Comirnaty (Pfizer), 6% Spikevax (Moderna), 38% Vaxzevria (AstraZeneca) and 2% Janssen Covid-19 vaccine. AESI were very rare <10/100,000 PY in 2020, only thrombotic and cardiac events were uncommon. After adjustment for factors associated with severe COVID, 10 statistically significant associations of pooled incidence rate ratios remained based on dose 1 and 2 combined. These comprised anaphylaxis after AstraZeneca vaccine, TTS after both AstraZeneca and Janssen vaccine, erythema multiforme after Moderna, GBS after Janssen vaccine, SOCV after Janssen vaccine, thrombocytopenia after Janssen and Moderna vaccine and VTE after Moderna and Pfizer vaccines. The pooled rate ratio was more than two-fold increased only for TTS, SOCV and thrombocytopenia. Conclusion We showed associations with several AESI, which remained after adjustment for factors that determined vaccine roll out. Hypotheses testing studies are required to establish causality.

First importations of SARS-CoV-2 P.1 and P.2 variants from Brazil to Spain and early community transmission Primeras importaciones de las variantes SARS-CoV-2 P.1 y P.2 de Brasil a Madrid y transmisión comunitaria

Introduction SARS-CoV-2variants of concern (VOC) have been described in the UK (B.1.1.7), South Africa (B.1.351) and Brazil (P.1). Among them, the most scarce information has been obtained from the P.1 variant and more data on its global presence and about its spreading dynamics are needed. Methods Whole genome sequencing was performed prospectively on travellers arriving from Brazil and on a random selection of SARS-CoV-2 positive cases from our population. Results In this study we report the first SARS-CoV-2 P.1 and P.2 variants exported from Brazil to Spain. The case infected with the P.1 variant, who had only stayed in Rio de Janeiro, required hospitalisation. The two P.2 cases remained asymptomatic. A wider distribution for P.1 variant beyond the Brazilian Amazonia should be considered. The exportation of the P.2 variant, carrying the E484K mutation, deserves attention. One month after the first description of P.1 and P.2 importations from Brazil to Madrid, these variants were identified circulating in the community, in cases without a travel history, and involved in household transmissions Conclusion Whole genome sequencing of SARS-CoV-2 positive travellers arriving from Brazil allowed us to identify the first importations of P.1 and P.2 variants to Spain and their early community transmission.

LIBERTAD DE CIRCULACIÓN DE LAS PERSONAS, LEYES DE POLICÍA SANITARIA Y COVID-19

Este trabajo trata de analizar, por un lado, la cobertura jurídica de las limitaciones generalizadas de la libertad de circulación, espaciales (cierres perimetrales) o temporales (confinamientos nocturnos) impuestas con ocasión de la pandemia del Covid-19 al amparo de la legislación sanitaria especial sobre salud pública. Por otro, estudia el mecanismo de autorización y ratificación de medidas sanitarias por parte de la jurisdicción contencioso-administrativa, todo ello en aras de comprobar la viabilidad de la imposición de dichas medidas al margen del Derecho de excepción y los problemas que ésta plantea.Alternate :This paper aims at analyzing, on the one hand, the territorial and time limitations of the freedom of movement imposed in Spain due to the Covid-19 pandemic on the basis of the health legislation. On the other hand, it also aims at studying the new authorization and ratification mechanism of health measures. The purpose of that all is to check the legal viability of that measures imposed outside of the law of exception and the problems it has recently raised.

Experiencia en el uso de videos para la promoción de ejercicio físico en el hogar en personas mayores en modalidad online en Chile durante la pandemia Covid19 Experience in the use of videos for the promotion of physical exercise at home in older adults in online mode in Chile during the Covid19 pandemic

Objetivo: Describir la usabilidad, accionabilidad y comprensión de videos para promover ejercicio en el hogar de manera online durante la pandemia Covid19, analizando las características de la población, su satisfacción, adherencia y barreras para realizar ejercicio físico. Material y Métodos: Estudio de diseño observacional descriptivo, no experimental y transversal, con enfoque cuantitativo. Se crearon videos de ejercicio físico y educación sobre dolor para personas mayores de 60 años, y fueron distribuidos en la Región Metropolitana (Chile) durante los meses de octubre a diciembre del 2020. La intervención consistió en el uso independiente en el hogar de estos videos, y tuvo una duración de 4 semanas. Luego voluntariamente se encuestó a una muestra que recibieron estos videos. Resultados: 34 participantes evaluaron los videos como comprensibles y accionables. La usabilidad fue menor en las personas que percibían un nivel de manejo tecnológico menor. La adherencia promedio fue de 2 días a la semana durante 2,5 semanas. La principal barrera percibida fue la falta de voluntad, la cual mostró una mayor tendencia en las personas que realizaban ejercicio físico de manera grupal antes de las restricciones por la pandemia Covid19. Conclusiones: Los videos desarrollados fueron una herramienta bien evaluada por parte de la población mayor, sin embargo la brecha tecnológica puede ser una limitante para favorecer un uso fácil y sencillo. Dentro de las estrategias se debería considerar intervenciones que favorezcan la interacción social para promover la motivación interpersonal en especial en las personas que prefieren modalidades grupales de ejercicio.

Puntaje radiográfico de evaluación del edema pulmonar (RALE) y su asociación con desenlaces clínicos en el síndrome de dificultad respiratoria aguda en Colombia Radiographic assessment of lung edema (RALE) score and its association with clinical outcomes in acute respiratory distress syndrome in Colombia

Introducción El síndrome de dificultad respiratoria agudo (SDRA) es actualmente el principal diagnóstico en las unidades de cuidado intensivo (UCI), el cual está relacionado con la pandemia del SARS-CoV-2. Este síndrome aumenta la estancia, los costos hospitalarios y tiene alta mortalidad. La radiografía de tórax es un método imprescindible en estos pacientes para el diagnóstico y seguimiento clínico, por ser económico y de uso rutinario en UCI. El puntaje RALE (evaluación radiográfica del edema pulmonar) permite la estimación de la extensión y densidad de las opacidades alveolares en la radiografía torácica y se ha asociado con diferentes desenlaces clínicos como la oxigenación, mortalidad a los 28 días, días libres de ventilador, estancia hospitalaria y severidad del SDRA. El objetivo de este trabajo es establecer la asociación del RALE con desenlaces clínicos de los pacientes con SDRA de nuestra institución. Materiales y métodos Estudio de cohorte ambispectiva, monocéntrico. Se incluyeron adultos mayores de 18 años con diagnóstico de SDRA hospitalizados en las UCI del Hospital Santa Clara, de Bogotá, Colombia, de enero a diciembre de 2020. Resultados El estudio incluyó 100 pacientes, el 93% con diagnóstico de SARS-CoV-2;se encontró asociación entre el RALE del primer día y la oxigenación del primer día de ingreso, pero no se halló relación estadísticamente significativa del RALE con los otros desenlaces. Conclusión El puntaje RALE no se asoció con los desenlaces clínicos relevantes en los pacientes con SDRA. Esto se puede explicar por los diferentes mecanismos de hipoxemia de estos pacientes. Se sugiere realizar otros estudios para confirmar estos hallazgos.

A One-Step open RT-qPCR for SARS-CoV-2 detection (preprint)

The Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), etiological agent of the coronavirus disease 2019 (COVID-19), is currently detected by reverse transcription followed by quantitative polymerase chain reaction (RT-qPCR) of its viral RNA genome. Within the available alternatives, One-Step procedures are preferred since they are fast and significantly decrease preanalytical errors, minimizing the risk of diagnostic errors. Increasing the testing capacity and tracing contacts are essential steps to control the pandemic. However, high-cost commercial reagents subject to shortage and poor scalability have hindered the use of these technologies and their adoption for a wide population-scale testing, being even more critical in developing countries. In the current context, open-source initiatives have promoted global collaboration to promote accessible solutions for rapid local deployment. As a result, open protocols are being developed for the local production of SARS-CoV-2 diagnostics. This work aimed to produce an open-source system for SARS-CoV-2 diagnostic tests in RNA clinical samples. We provide guidelines for standardizing an open One-Step RT-qPCR master mix using recombinant M-MLV reverse transcriptase together with either Pfu-Sso7d or Taq DNA polymerase. Both were tested on synthetic RNA and clinical samples, observing a good correlation when compared to commercial RT-qPCR kits. Nevertheless, the best results were obtained using M-MLV RT combined with Taq DNA polymerase in a probe-based RT-qPCR assay, allowing successful discrimination between positive and negative samples with accuracies comparable to a CDC-recommended commercial kit. Here, we demonstrate that these open RT-qPCR systems can be successfully used to identify SARS-CoV-2 in clinical samples and potentially be implemented in any molecular diagnostic laboratory.

Corticosteroids Use and Risk of Respiratory Coinfections in Mechanically Ventilated Patients With COVID-19 (preprint)

Background: To describe respiratory coinfections, predictive factors and outcomes in patients requiring mechanical ventilation (MV) with COVID-19. Methods Cohort study, carried out in a Chilean single tertiary Hospital. All patients with COVID-19 admitted to ICU that required MV were included between 1 June and 31 July 2020. Results 175 patients were admitted to ICU and required MV. Of these, 71 patients developed at least one respiratory coinfection (40.6 %). Early coinfections and late coinfections were diagnosed in 1.7% and 31.4% of all patients admitted to ICU respectively. Within late coinfections, 88% were bacterial, 10% were fungal, and 2% were viral coinfections. One third of isolated bacteria were multidrug-resistant. Multivariate analysis showed that the risk for coinfection was 7.7 times higher for patients with history of corticosteroids ( ad OR = 7.65, CI 95%: 1.04-56.2, p=0,046) and 2.7 times higher for patients that received dexamethasone during hospitalization ( ad OR=2.69; CI 95%: 1.14-6.35, p=0,024) than patients that were not exposed. For each additional day in MV, the risk of coinfection increases 1.1 times ( ad OR=1.06; CI 95%: 1.01-1.11, p=0,025). Conclusions Patients in ICU with COVID-19 that require MV had a high rate of coinfections during their stay, but not at admission. Major predisposing factors are the history of corticosteroids, the use of dexamethasone during hospitalization and days in MV.

The impact of the COVID-19 pandemic on Sexually Transmitted Infections surveillance data: incidence drop or artefact?

BACKGROUND: Before the COVID-19 pandemic, Sexually transmitted infections (STIs) were increasing in Europe, and Spain and Catalonia were not an exception. Catalonia has been one of the regions with the highest number of COVID-19 confirmed cases in Spain. The objective of this study was to estimate the magnitude of the decline, due to the COVID-19 pandemic, in the number of STI confirmed cases in Catalonia during the lockdown and de-escalation phases. METHODS: Interrupted time series analysis was performed to estimate the magnitude of decline in the number of STI reported confirmed cases - chlamydia, gonorrhoea, syphilis, and lymphogranuloma venereum- in Catalonia since lockdown with historical data, from March 13th to August 1st 2020, comparing the observed with the expected values. RESULTS: We found that since the start of COVID-19 pandemic the number of STI reported cases was 51% less than expected, reaching an average of 56% during lockdown (50% and 45% during de-escalation and new normality) with a maximum decrease of 72% for chlamydia and minimum of 22% for syphilis. Our results indicate that fewer STIs were reported in females, people living in more deprived areas, people with no previous STI episodes during the last three years, and in the HIV negative. CONCLUSIONS: The STI notification sharp decline was maintained almost five months after lockdown started, well into the new normality. This fact can hardly be explained without significant underdiagnosis and underreporting. There is an urgent need to strengthen STI/HIV diagnostic programs and services, as well as surveillance, as the pandemic could be concealing the real size of the already described re-emergence of STIs in most of the European countries.

Epidemiological characteristics and outcomes of COVID-19 cases: mortality inequalities by socio-economic status, Barcelona, Spain, 24 February to 4 May 2020.

BackgroundPopulation-based studies characterising outcomes of COVID-19 in European settings are limited, and effects of socio-economic status (SES) on outcomes have not been widely investigated. AimWe describe the epidemiological characteristics of COVID-19 cases, highlighting incidence and mortality rate differences across SES during the first wave in Barcelona, Catalonia, Spain.MethodsThis population-based study reports individual-level data of laboratory-confirmed COVID-19 cases diagnosed from 24 February to 4 May 2020, notified to the Public Health Agency of Barcelona and followed until 15 June 2020. We analysed end-of-study vital status and the effects of chronic conditions on mortality using logistic regression. Geocoded addresses were linked to basic health area SES data, estimated using the composed socio-economic index. We estimated age-standardised incidence, hospitalisation, and mortality rates by SES.ResultsOf 15,554 COVID-19-confirmed cases, the majority were women (n = 9,028; 58%), median age was 63 years (interquartile range: 46-83), 8,046 (54%) required hospitalisation, and 2,287 (15%) cases died. Prevalence of chronic conditions varied across SES, and multiple chronic conditions increased risk of death (≥ 3, adjusted odds ratio: 2.3). Age-standardised rates (incidence, hospitalisation, mortality) were highest in the most deprived SES quartile (incidence: 1,011 (95% confidence interval (CI): 975-1,047); hospitalisation: 619 (95% CI: 591-648); mortality: 150 (95% CI: 136-165)) and lowest in the most affluent (incidence: 784 (95% CI: 759-809); hospitalisation: 400 (95% CI: 382-418); mortality: 121 (95% CI: 112-131)).ConclusionsCOVID-19 outcomes varied markedly across SES, underscoring the need to implement effective preventive strategies for vulnerable populations.

COVID-19 IN YOUNG AND MIDDLE-AGED ADULTS. PREDICTORS OF POOR OUTCOME AND CLINICAL DIFFERENCES. (preprint)

ABSTRACT Young and middle-aged adults are the largest group of patients infected with SARS-CoV-2 and some of them develop severe disease. Objective: To investigate clinical manifestations in adults aged 18-65 years hospitalized for COVID-19 and identify predictors of poor outcome. Secondary objectives: to explore potential differences compared to the disease in elderly patients and the suitability of the commonly used community-acquired pneumonia prognostic scales in younger populations. Methods: Multicenter prospective registry of consecutive patients hospitalized for COVID-19 pneumonia aged 18-65 years between March and May 2020. We considered a composite outcome of “poor outcome” including intensive care unit admission and/or use of noninvasive ventilation, continuous positive airway pressure or high flow nasal cannula oxygen therapies and/or death. Results: We identified 513 patients <65 years of age, from a cohort of 993 patients. 102 had poor outcomes (19.8%) and 3.9% died. 78% and 55% of patients with poor outcomes were classified as low risk based on CURB and PSI scores respectively. A multivariate Cox regression model identified six independent factors associated with poor outcome: heart disease, chest pain, anosmia, low oxygen saturation, high LDH and lymphocyte count <800/mL. Conclusions: COVID-19 in younger patients carries significant morbidity and differs in some respects from this disease the elderly. Baseline heart disease is a relevant risk factor, while anosmia and pleuritic pain are more common and protective. Hypoxemia, LDH and lymphocyte count are predictors of poor outcome. We consider that CURB and PSI scores are not suitable criteria for deciding admission in this population.

High incidence of pulmonary thromboembolism in hospitalized SARS-CoV-2 infected patients (preprint)

Introduction SARS-CoV-2 infected patients present thrombotic complications caused by direct endothelial cells injury of the microvessels. Pulmonary thromboembolism (PE) has been reported by Computed Tomography pulmonary angiogram (CTPA) in patients with COVID-19 pneumonia with high D-dimer levels. Objectives We present the characteristics of SARS-CoV-2 infected patients diagnosed of PE by CTPA in our hospital. We also present the comparison of these findings with non-infected patients with PE data. Methods Patients 18 years of age or older with SARS-CoV2 virus infection, and patients with suspected infection at beginning of admission but with negative PCR, were studied with CTPA for suspicion of VTE, during their hospitalization. Results During the study period, 52 CTPA were performed in our hospital, sixteen in SARS-CoV-2 infected patients. No significant differences in age (p=0.43) and sex (p=0.31) were found between the two groups, infected and non-infected patients. In the infected group, the patients who had PE had a much lower median age (47.8 years) than those without PE (73.3 years). No differences between infected and non-infected patients were detected in the diagnosis of PE with CTPA, 28.6% versus 27.8% (p=1.00). Overall patient mortality was 1.9%; one patient died (6.3%) in the infected group, and none in the non-infected group (p=0.31). Conclusion A considerable incidence of PE diagnosed by CTPA in SARS-CoV-2 infected patients has been observed, despite thrombo-prophylaxis.

Performance of SARS-CoV-2 rapid antigen test compared with real-time RT-PCR in asymptomatic individuals (preprint)

Screening, testing and contact tracing plays a pivotal role in the control of COVID-19 pandemic. To carry out this strategy it is necessary to increase the testing capacity. Here, we compared a SARS CoV-2 rapid antigen test (RAT) and RT-PCR in 842 asymptomatic individuals from Tarapacá, Chile. We report a sensibility of 69.86%, a specificity of 99.61%, PPV of 94.44% and NPP of 97.22% with Ct values (Ct > 27) that were significantly higher among individuals with false-negative RAT. These results support the fact that RAT might have a significant impact in the identification of asymptomatic carriers in areas that lack well-equipped laboratories to perform SARS-CoV-2 real -time RT-PCR diagnostics or the results take more than 24-48 hours, as well as zones with high traffic of individuals, such as border/customs, airports, interregional bus, train stations or in any mass testing campaign requiring rapid results.

A simple RNA preparation method for SARS-CoV-2 detection by RT-qPCR (preprint)

The technique RT-qPCR for viral RNA detection is the current worldwide strategy used for early detection of the novel coronavirus SARS-CoV-2. RNA extraction is a key pre-analytical step in RT-qPCR, often achieved using commercial kits. However, the magnitude of the COVID-19 pandemic is causing disruptions to the global supply chains used by many diagnostic laboratories to procure the commercial kits required for RNA extraction. Shortage in these essential reagents is even more acute in developing countries with no means to produce kits locally. We sought to find an alternative procedure to replace commercial kits using common reagents found in molecular biology laboratories. Here we report a method for RNA extraction that takes about 40 min to complete ten samples and is not more laborious than current commercial RNA extraction kits. We demonstrate that this method can be used to process nasopharyngeal swab samples and yields RT-qPCR results comparable to those obtained with commercial kits. Most importantly, this procedure can be easily implemented in any molecular diagnostic laboratory. Frequent testing is crucial for individual patient management as well as for public health decision making in this pandemic. Implementation of this method could maintain crucial testing going despite commercial kit shortages.