Search

Background: The COVID-19 pandemic immensely impacted care provision, including quality of care in general practice. This paper aimed: (1) to assess how Belgian general practices acted upon the six dimensions of quality of care during COVID-19; (2) to study differences between the three Belgian regions; and (3) to benchmark the performance of the Belgian practices against the performance in other European countries. Methods: The data collected from 479 Belgian practices during 2020–2021 using an online survey as part of the international cross-sectional PRICOV-19 study were analyzed. Hereby, descriptive statistics, chi-squared tests, and binary logistic regression analyses were performed. Thirty-four survey questions related to the six dimensions of quality of care were selected as outcome variables. The adjusted regression models included four practice characteristics as covariates: practice type, being a teaching practice for GP trainees, multidisciplinarity of the team, and payment system. Results: Belgian practices made important organizational changes to deliver high-quality care during COVID-19. Most practices (n = 259; 56.1%) actively reached out to vulnerable patients. Limitations to the practice building or infrastructure threatened high-quality care in 266 practices (55.5%). Infection prevention measures could not always be implemented during COVID-19, such as using a cleaning protocol (n = 265; 57.2%) and providing a separate doctor bag for infection-related home visits (n = 130; 27.9%). Three hundred and sixty practices (82.0%) reported at least one safety incident related to a delayed care process in patients with an urgent condition. The adjusted regression analysis showed limited significant differences between the Belgian regions regarding the quality of care delivered. Belgian practices demonstrated varied performance compared to other European countries. For example, they excelled in always checking the feasibility of isolation at home but reported more patient safety incidents related to timely care than at least three-quarters of the other European countries. Conclusions: Future studies using different design methods are crucial to investigate which country and practice characteristics are associated with delivering high-quality care. [ABSTRACT FROM AUTHOR]

Background: Non-pharmaceutical interventions (NPIs) were adopted in Belgium in order to decrease social interactions between people and as such decrease viral transmission of SARS-CoV-2. With the aim to better evaluate the impact of NPIs on the evolution of the pandemic, an estimation of social contact patterns during the pandemic is needed when social contact patterns are not available yet in real time. Methods: In this paper we use a model-based approach allowing for time varying effects to evaluate whether mobility and pre-pandemic social contact patterns can be used to predict the social contact patterns observed during the COVID-19 pandemic between November 11, 2020 and July 4, 2022. Results: We found that location-specific pre-pandemic social contact patterns are good indicators for estimating social contact patterns during the pandemic. However, the relationship between both changes with time. Considering a proxy for mobility, namely the change in the number of visitors to transit stations, in interaction with pre-pandemic contacts does not explain the time-varying nature of this relationship well. Conclusion: In a situation where data from social contact surveys conducted during the pandemic are not yet available, the use of a linear combination of pre-pandemic social contact patterns could prove valuable. However, translating the NPIs at a given time into appropriate coefficients remains the main challenge of such an approach. In this respect, the assumption that the time variation of the coefficients can somehow be related to aggregated mobility data seems unacceptable during our study period for estimating the number of contacts at a given time. [ABSTRACT FROM AUTHOR]

Background: Belgium was one of the countries that was struck hard by COVID-19. Initially, the belief was that we were 'all in it together'. Emerging evidence showed however that deprived socioeconomic groups suffered disproportionally. Yet, few studies are available for Belgium. The main question addressed in this paper is whether excess mortality during the first COVID-19 wave followed a social gradient and whether the classic mortality gradient was reproduced. Methods: We used nationwide individually linked data from the Belgian National Register and the Census 2011. Age-standardized all-cause mortality rates were calculated during the first COVID-19 wave in weeks 11-20 in 2020 and compared with the rates during weeks 11-20 in 2015-2019 to calculate absolute and relative excess mortality by socioeconomic and -demographic characteristics. For both periods, relative inequalities in total mortality between socioeconomic and -demographic groups were calculated using Poisson regression. Analyses were stratified by age, gender and care home residence. Results: Excess mortality during the first COVID-19 wave was high in collective households, with care homes hit extremely hard by the pandemic. The social patterning of excess mortality was rather inconsistent and deviated from the usual gradient, mainly through higher mortality excesses among higher socioeconomic groups classes in specific age-sex groups. Overall, the first COVID-19 wave did not change the social patterning of mortality, however. Differences in relative inequalities between both periods were generally small and insignificant, except by household living arrangement. Conclusion: The social patterning during the first COVID-19 wave was exceptional as excess mortality did not follow the classic lines of higher mortality in lower classes and patterns were not always consistent. Relative mortality inequalities did not change substantially during the first COVID-19 wave compared to the reference period. [ABSTRACT FROM AUTHOR]

Background: Survey data were needed to assess the mental and social health, health related behaviors and compliance with preventive measures of the population during the COVID-19 pandemic. Yet, the pandemic challenged classical survey methods. Time and budgetary constraints at the beginning of the pandemic led to ad hoc recruitment of participants and easily manageable data collection modes. This paper describes the methodological choices and results in terms of participation for the COVID-19 health surveys conducted in Belgium. Methods: The COVID-19 health surveys refer to a series of ten non-probability web surveys organized between April 2020 and March 2022. The applied recruitment strategies were diverse including, amongst others, a launch through the website and the social media of the organizing research institute. In addition, the survey links were shared in articles published in the national press and participants were requested to share the surveys in their network. Furthermore, participants were asked consent to be re-contacted for next survey editions using e-mail invitations. Results: These mixed approaches allowed to reach a substantial number of participants per edition ranging from 49339 in survey 1 to 13882 in survey 10. In addition, a longitudinal component was created; a large share of the same individuals were followed up over time; 12599 participants completed at least 5 surveys. There were, however, sex, age, educational level and regional differences in participation. Post-stratification weighting on socio-demographic factors was applied to at least partly take this into account. Conclusion: The COVID-19 health surveys allowed rapid data collection after the onset of the pandemic. Data from these non-probability web surveys had their limitations in terms of representativeness due to self-selection but were an important information source as there were few alternatives. Moreover, by following-up the same individuals over time it was possible to study the effect of the different crisis phases on, amongst others, the mental health. It is important to draw lessons from these experiences: initiatives in order to create a survey infrastructure better equipped for future crises are needed. [ABSTRACT FROM AUTHOR]

Background: The COVID-19 pandemic and subsequent suppression measures have had health and social implications for billions of individuals. The aim of this paper is to investigate the risk of psychological distress associated with the COVID-19 pandemic and suppression measures during the early days of the lockdown. We compared the level of psychological distress at the beginning of that period with a pre-pandemic health survey and assessed the psychological effects of exposure to the COVID-19 pandemic and changes in social activity and support. Methods: An online survey was distributed to the general population in Belgium 3 days after the beginning of the lockdown. 20,792 respondents participated. The psychological distress of the population was measured using the GHQ-12 scale. Social activities and support were assessed using the Social Participation Measure, the Short Loneliness Scale, and the Oslo Social Support Scale. An index of subjective exposure to the COVID-19 pandemic was constructed, as well as a measure of change in occupational status. Measurements were compared to a representative sample of individuals extracted from the Belgian Health Interview Survey of 2018. Bootstrapping was performed and analyses were reweighted to match the Belgian population in order to control for survey selection bias. Results: Half of the respondents reported psychological distress in the early days of the lockdown. A longer period of confinement was associated with higher risk of distress. Women and younger age groups were more at risk than men and older age groups, as were respondents who had been exposed to COVID-19. Changes in occupational status and a decrease in social activity and support also increased the risk of psychological distress. Comparing the results with those of the 2018 Belgian Health Interview shows that the early period of the lockdown corresponded to a 2.3-fold increase in psychological distress (95% CI: 2.16–2.45). Conclusions: Psychological distress is associated with the consequences of the COVID-19 pandemic and suppression measures. The association is measurable from the very earliest days of confinement and it affected specific at-risk groups. Authorities should consider ways of limiting the effect of confinement on the mental and social health of the population and developing strategies to mitigate the adverse consequences of suppression measures. [ABSTRACT FROM AUTHOR]

Background: General practitioners (GPs) have a vital role in reaching out to vulnerable populations during and after the COVID-19 pandemic. Nonetheless, they experience many challenges to fulfill this role. This study aimed to examine associations between practice characteristics, patient population characteristics and the extent of deprivation of practice area on the one hand, and the level of outreach work performed by primary care practices (PCPs) during the COVID-19 pandemic on the other hand. Methods: Belgian data from the international PRICOV-19 study were analyzed. Data were collected between December 2020 and August 2021 using an online survey in PCPs. Practices were recruited through randomized and convenience sampling. Descriptive statistics and ordinal logistic regression analyses were performed. Four survey questions related to outreach work constitute the outcome variable. The adjusted models included four practice characteristics (practice type, being a teaching practice for GP trainees; the presence of a nurse or a nurse assistant and the presence of a social worker or health promotor), two patient population characteristics (social vulnerability and medical complexity) and an area deprivation index. Results: Data from 462 respondents were included. First, the factors significantly associated with outreach work in PCPs are the type of PCP (with GPs working in a group performing more outreach work), and the presence of a nurse (assistant), social worker or health promotor. Second, the extent of outreach work done by a PCP is significantly associated with the social vulnerability of the practice's patient population. This social vulnerability factor, affecting outreach work, differed with the level of medical complexity of the practice's patient population and with the level of deprivation of the municipality where the practice is situated. Conclusions: In this study, outreach work in PCPs during the COVID-19 pandemic is facilitated by the group-type cooperation of GPs and by the support of at least one staff member of the disciplines of nursing, social work, or health promotion. These findings suggest that improving the effectiveness of outreach efforts in PCPs requires addressing organizational factors at the practice level. This applies in particular to PCPs having a more socially vulnerable patient population. [ABSTRACT FROM AUTHOR]

The trajectory of COVID-19 epidemic waves in the general population of Belgium was analysed by defining quantitative criteria for epidemic waves from March 2020 to early 2023. Peaks and starting/ending times characterised nine waves numerated I to IX based on the daily reported incidence number (symbol INCID) and three "endemic" interval periods between the first four waves. The SIR compartmental model was applied to the first epidemic wave by fitting the daily prevalence pool (symbol I) calculated as the sum of the daily incidence rate and estimated number of subjects still infectious from the previous days. The basic reproductive number R0 was calculated based on the exponential growth rate during the early phase and on medical literature knowledge of the time of generation of SARS-CoV-2 infection. The first COVID-19 wave was well fitted by an open SIR model. According to this approach, dampened recurrent epidemic waves evolving through an endemic state would have been expected. This was not the case with the subsequent epidemic waves being characterised by new variants of concern (VOC). Evidence-based observations: 1) each epidemic wave affected less than a fifth of the general population; 2) the Vth epidemic wave (VOC Omicron) presented the greatest amplitude. The lack of recurrence of the same VOC during successive epidemic waves strongly suggests that a VOC has a limited persistence, disappearing from the population well before the expected proportion of the theoretical susceptible cohort being maximally infected. Fitting the theoretical SIR model, a limited persistence of VOCs in a population could explain that new VOCs replace old ones, even if the new VOC has a lower transmission rate than the preceding one. In conclusion, acquisition of potential defective mutations in VOC during an epidemic wave is a potential factor explaining the absence of resurgence of a same VOC during successive waves. Such an hypothesis is open to discussion and to rebuttal. A modified SIR model with epidemic waves of variable amplitude related not only to R0 and public health measures but also to acquisition of defective fitting in virus within a population should be tested. [ABSTRACT FROM AUTHOR]

Background: During the COVID-19 pandemic, the CoMix study, a longitudinal behavioral survey, was designed to monitor social contacts and public awareness in multiple countries, including Belgium. As a longitudinal survey, it is vulnerable to participants' "survey fatigue", which may impact inferences. Methods: A negative binomial generalized additive model for location, scale, and shape (NBI GAMLSS) was adopted to estimate the number of contacts reported between age groups and to deal with under-reporting due to fatigue within the study. The dropout process was analyzed with first-order auto-regressive logistic regression to identify factors that influence dropout. Using the so-called next generation principle, we calculated the effect of under-reporting due to fatigue on estimating the reproduction number. Results: Fewer contacts were reported as people participated longer in the survey, which suggests under-reporting due to survey fatigue. Participant dropout is significantly affected by household size and age categories, but not significantly affected by the number of contacts reported in any of the two latest waves. This indicates covariate-dependent missing completely at random (MCAR) in the dropout pattern, when missing at random (MAR) is the alternative. However, we cannot rule out more complex mechanisms such as missing not at random (MNAR). Moreover, under-reporting due to fatigue is found to be consistent over time and implies a 15-30% reduction in both the number of contacts and the reproduction number ( R 0 ) ratio between correcting and not correcting for under-reporting. Lastly, we found that correcting for fatigue did not change the pattern of relative incidence between age groups also when considering age-specific heterogeneity in susceptibility and infectivity. Conclusions: CoMix data highlights the variability of contact patterns across age groups and time, revealing the mechanisms governing the spread/transmission of COVID-19/airborne diseases in the population. Although such longitudinal contact surveys are prone to the under-reporting due to participant fatigue and drop-out, we showed that these factors can be identified and corrected using NBI GAMLSS. This information can be used to improve the design of similar, future surveys. [ABSTRACT FROM AUTHOR]

Background: Pre-existing racial/ethnic disparities in health, sustained by intersecting socio-economic and structural inequities, have widened due to the COVID-19 pandemic. Yet, little attention has been paid to the lived experiences of people in ethnic/racialised minority communities, and to the causes and effects underlying the COVID-19-related burden. This hinders tailored responses. This study explores Sub-Saharan African (SSA) communities' needs, perceptions, and experiences of the COVID-19 pandemic and its control measures in Antwerp (Belgium) in 2020. Methods: This qualitative study using an interpretative ethnographical approach adopted an iterative and participatory methodology: a community advisory board advised on all stages of the research process. Interviews and a group discussion were conducted online, through telephone, and face-to-face. We analysed the data inductively using a thematic analytical approach. Results: Our respondents, who mostly used social media for information, struggled with misinformation about the new virus and prevention measures. They reported to be vulnerable to misinformation about the origin of the pandemic, risk of infection with SARS-CoV-2, and the prevention measures. Not only did the epidemic affect SSA communities, but to a larger extent, the control strategies did—especially the lockdown. Respondents perceived the interaction of social factors (i.e. being migrants, being undocumented, having experienced racism and discrimination) and economic factors (i.e. working in temporary and precarious jobs, not being able to apply for unemployment benefit, crowded housing conditions) as increasing the burden of COVID-19 control measures. In turn, these experiences influenced people's perceptions and attitudes, and may have partially impaired them to follow some public health COVID-19 prevention guidelines. Despite these challenges, communities developed bottom-up initiatives to react quickly to the epidemic, including translation of prevention messages, food distribution, and online spiritual support. Conclusion: Pre-existing disparities influenced the perceptions of and attitudes towards COVID-19 and its control strategies among SSA communities. To better design support and control strategies targeted to specific groups, we need to not only involve communities and address their specific needs and concerns, but also build on their strengths and resilience. This will remain important in the context of widening disparities and future epidemics. [ABSTRACT FROM AUTHOR]

Background: Policymakers worldwide took measures to limit the spread of the COVID-19-virus. While these sanitary measures were necessary to fight the spread of the virus, several experts warned for a significant impact on mental health and a potential increase in domestic violence. To study the impact of the COVID-19 measures in Belgium, and the factors influencing the occurrence of domestic violence, we set up the study on relationships, stress, and aggression. In this study, we evaluate the prevalence of domestic violence victimization during the COVID-19 lockdown in Belgian children aged zero to seventeen years and the associations of the parents' financial status, relationships, mental health, and previous victimization to the child's victimization.Methods: A stepwise forward binary logistic regression was used to analyse the association between multiple risk factors of domestic violence and victimization of the respondent's child. The respondent being an assailant, the respondent's age, and the age of the children in the household were added as moderators.Results: In this model an association with domestic child abuse was found for the age of the respondent, the household's size, the presence of children between zero and five years in the household, the perceived stress level of the respondent, and victimization of the respondent during the first wave of the sanitary measures, as well as victimization before the COVID-19 pandemic. None of the interacting effects were found to be significant.Conclusion: It is advisable to make extra efforts to improve well-being when maintaining sanitary measures by providing appropriate assistance and helping households struggling with increased or acute stress to install positive coping strategies - especially in larger households with children between six and 17 years. Besides, our findings draw attention to the clustering of risk of child and adult violence exposure in lockdown situations as well as to the potential cumulative impact of exposure to violence across the lifespan and across generations. It is key to invest in training healthcare workers and staff at schools to screen for and assess risks of domestic violence development and ongoing or past occurrence in order to detect, refer and follow-up on families at risk. [ABSTRACT FROM AUTHOR]

Background: As a hard-hit area during the COVID-19 pandemic, Belgium knew the highest mortality among people from sub-Saharan African descent, compared to any other group living in the country. After migration, people often maintain traditional perceptions and habits regarding health and healthcare, resulting in a high prevalence of traditional, complementary and alternative medicine use among different migrant communities in northern urban settings. Despite being the largest community of sub-Saharan African descent in Belgium, little is known on ethnobotanical practices of the Belgian Congolese community. We therefore conducted an exploratory study on the use of medicinal plants in the context of COVID-19 and perceptions on this new disease among members of the Congolese community in Belgium. Methods: We conducted 16 in-depth semi-structured interviews with people of Congolese descent currently living in Belgium. Participants were selected using purposive sampling. Medicinal plant use in the context of COVID-19 was recorded through free-listing. Data on narratives, ideas and perceptions on the origin, cause/aetiology and overall measures against COVID-19 (including vaccination) were collected. Interview transcripts were analysed using thematic analysis. Results: Four overarching themes emerged from our data. Firstly, participants perceived the representation of the severity of COVID-19 by the Belgian media and government—and by extend by all governmental agencies in the global north—as exaggerated. As a result, traditional and complementary treatments were seen as feasible options to treat symptoms of the disease. Fifteen forms of traditional, complementary and alternative medicine were documented, of which thirteen were plants. Participants seem to fold back on their Congolese identity and traditional knowledge in seeking coping strategies to deal with the COVID-19 pandemic. Finally, institutional postcolonial distrust did not only seem to lead to distrust in official messages on the COVID-19 pandemic but also to feelings of vaccination hesitancy. Conclusion: In the context of the COVID-19 pandemic, participants in our study retreated to, reshaped and adapted traditional and culture-bound knowledge. This study suggests that the fragile and sensitive relationship between sub-Saharan African migrant groups and other social/ethnic groups in Belgium might play a role in their sensitivity to health-threatening situations, such as the COVID-19 pandemic. [ABSTRACT FROM AUTHOR]

Background: In response to the ongoing COVID-19 pandemic, several countries adopted measures of social distancing to a different degree. For many countries, after successfully curbing the initial wave, lockdown measures were gradually lifted. In Belgium, such relief started on May 4th with phase 1, followed by several subsequent phases over the next few weeks.Methods: We analysed the expected impact of relaxing stringent lockdown measures taken according to the phased Belgian exit strategy. We developed a stochastic, data-informed, meta-population model that accounts for mixing and mobility of the age-structured population of Belgium. The model is calibrated to daily hospitalization data and is able to reproduce the outbreak at the national level. We consider different scenarios for relieving the lockdown, quantified in terms of relative reductions in pre-pandemic social mixing and mobility. We validate our assumptions by making comparisons with social contact data collected during and after the lockdown.Results: Our model is able to successfully describe the initial wave of COVID-19 in Belgium and identifies interactions during leisure/other activities as pivotal in the exit strategy. Indeed, we find a smaller impact of school re-openings as compared to restarting leisure activities and re-openings of work places. We also assess the impact of case isolation of new (suspected) infections, and find that it allows re-establishing relatively more social interactions while still ensuring epidemic control. Scenarios predicting a second wave of hospitalizations were not observed, suggesting that the per-contact probability of infection has changed with respect to the pre-lockdown period.Conclusions: Contacts during leisure activities are found to be most influential, followed by professional contacts and school contacts, respectively, for an impending second wave of COVID-19. Regular re-assessment of social contacts in the population is therefore crucial to adjust to evolving behavioral changes that can affect epidemic diffusion. [ABSTRACT FROM AUTHOR]

Background: The importance of community involvement in the response against disease outbreaks has been well established. However, we lack insights into local communities' experiences in coping with the current COVID-19 pandemic. This study explored both the impact of, and response to, COVID-19 within the Orthodox Jewish communities of Antwerp (Belgium) during the first lockdown period (March 2020 – May 2020). Methods: We conducted an explorative qualitative study using a participatory approach. First, we performed a community mapping to identify relevant stakeholders. Through the active involvement of a community advisory board and based on qualitative interviews with key-informants and community members, we elicited lived experiences, attitudes, and perceptions towards COVID-19. Interviews were conducted both face-to-face and using online web conferencing technology. Data were analyzed inductively according to the principles of thematic analysis. Results: Government-issued outbreak control measures presented context-specific challenges to the Orthodox Jewish communities in Antwerp. They related mainly to the remote organization of religious life, and practicing physical distancing in socially and culturally strongly connected communities. Existing community resources were rapidly mobilized to adapt to the outbreak and to self-organize response initiatives within communities. The active involvement of community and religious leaders in risk communication proved to be of great importance to facilitate the coverage and uptake of pandemic control measures while protecting essential community values and traditions. Creating bottom-up and community-adapted communication strategies, including addressing language barriers and involving Rabbis in the dissemination of prevention messages, fostered a feeling of trust in government's response measures. However, unmet information and prevention needs were also identified, such as the need for inclusive communication by public authorities and the need to mitigate the negative effects of stigmatization. Conclusion: The experiences of Orthodox Jewish communities in Antwerp demonstrate a valuable example of a feasible community-centered approach to health emergencies. Increasing the engagement of communities in local decision-making and governance structures remains a key strategy to respond to unmet information and prevention needs. [ABSTRACT FROM AUTHOR]

Background: Previous studies have reported a negative psychological and mental health impact of the COVID-19 pandemic. This impact is likely to be stronger for people with autism as they are at heightened risk of mental health problems and because the pandemic directly affects social functioning and everyday routines. We therefore examined COVID-19 pandemic-related changes in mental health, the impact of the pandemic on their social life and routines, satisfaction with pandemic-related information and tips, and participants' wishes for guidance. Methods: We used a mixed-method approach, collecting quantitative and qualitative survey data from adults with and without autism across three European countries: Belgium, the Netherlands, and the UK (N = 1044). Results: We found an increase in depression and anxiety symptoms in response to the pandemic for both the non-autism and the autism group, which was greater for adults with autism. Furthermore, adults with autism showed a greater increase in worries about their pets, work, getting medication and food, and their own safety/security. They felt more relieved from social stress, yet experienced the loss of social contact as difficult. Adults with autism also felt more stressed about the loss of routines. Pleasant changes noted by adults with autism were the increase in solidarity and reduced sensory and social overload. Adults with autism frequently reported problems with cancellation of guidance due to the pandemic and expressed their wish for (more) autism-specific information and advice. Limitations: Our sample is likely to reflect some degree of selection bias, and longitudinal studies are needed to determine long-term effects. Conclusions: Results highlight the psychological burden of the pandemic on adults with autism and shed light on how to support them during this COVID-19 pandemic, which is especially important now that the pandemic is likely to have a prolonged course. There is a need for accessible, affordable (continued) support from health services. Guidance may focus on the maintenance of a social network, and adjusting routines to the rapid ongoing changes. Finally, we may learn from the COVID-19 pandemic-related changes experienced as pleasant by adults with autism to build a more autism-friendly society post-pandemic. [ABSTRACT FROM AUTHOR]

Background: The COVID-19 pandemic has imposed an enormous burden on health care systems around the world. In the past, the administration of convalescent plasma of patients having recovered from SARS and severe influenza to patients actively having the disease showed promising effects on mortality and appeared safe. Whether or not this also holds true for the novel SARS-CoV-2 virus is currently unknown. Methods: DAWn-Plasma is a multicentre nation-wide, randomized, open-label, phase II proof-of-concept clinical trial, evaluating the clinical efficacy and safety of the addition of convalescent plasma to the standard of care in patients hospitalized with COVID-19 in Belgium. Patients hospitalized with a confirmed diagnosis of COVID-19 are eligible when they are symptomatic (i.e. clinical or radiological signs) and have been diagnosed with COVID-19 in the 72 h before study inclusion through a PCR (nasal/nasopharyngeal swab or bronchoalveolar lavage) or a chest-CT scan showing features compatible with COVID-19 in the absence of an alternative diagnosis. Patients are randomized in a 2:1 ratio to either standard of care and convalescent plasma (active treatment group) or standard of care only. The active treatment group receives 2 units of 200 to 250 mL of convalescent plasma within 12 h after randomization, with a second administration of 2 units 24 to 36 h after ending the first administration. The trial aims to include 483 patients and will recruit from 25 centres across Belgium. The primary endpoint is the proportion of patients that require mechanical ventilation or have died at day 15. The main secondary endpoints are clinical status on day 15 and day 30 after randomization, as defined by the WHO Progression 10-point ordinal scale, and safety of the administration of convalescent plasma. Discussion: This trial will either provide support or discourage the use of convalescent plasma as an early intervention for the treatment of hospitalized patients with COVID-19 infection. Trial registration: ClinicalTrials.govNCT04429854. Registered on 12 June 2020 - Retrospectively registered. [ABSTRACT FROM AUTHOR]

Background: The COVID-19 pandemic affects the processes of routine care for chronic patients. A better understanding helps to increase resilience of the health system and prepare adequately for next waves of the pandemic. Methods: A qualitative study was conducted in 16 primary care practices: 6 solo working, 4 monodisciplinary and 7 multidisciplinary. Twenty-one people (doctors, nurses, dieticians) were interviewed, using semi-structured video interviews. A thematic analysis was done using the domains of the Chronic Care Model (CCM). Results: Three themes emerged: changes in health care organization, risk stratification and self-management support. All participating practices reported drastic changes in organization with a collective shift towards COVID-19 care, and reduction of chronic care activities, less consultations, and staff responsible for self-management support put on hold. A transition to digital support did not occur. Few practitioners had a systematic approach to identify and contact high-risk patients for early follow-up. A practice with a pre-established structured team collaboration managed to continue most chronic care elements. Generally, practitioners expected no effects of the temporary disruption for patients, although they expressed concern about patients already poorly regulated. Conclusion: Our findings show a disruption of the delivery of chronic care in the Belgium prim care context. In such contexts, the establishment of the CCM can facilitate continuity of care in crisis times. Short term actions should be directed to facilitate identifying high-risk patients and to develop a practice organization plan to organize chronic care and use digital channels for support, especially to vulnerable patients, during next waves of the epidemic. [ABSTRACT FROM AUTHOR]

Objectives: The purpose of this study is to test the safety and effectiveness of individually or simultaneously blocking IL-6, IL-6 receptor and IL-1 versus standard of care on blood oxygenation and systemic cytokine release syndrome in patients with COVID-19 coronavirus infection and acute hypoxic respiratory failure and systemic cytokine release syndrome.Trial Design: A phase 3 prospective, multi-center, interventional, open label, 6-arm 2x2 factorial design study.Participants: Subjects will be recruited at the specialized COVID-19 wards and/or ICUs at 16 Belgian participating hospitals. Only adult (≥18y old) patients will be recruited with recent (≤16 days) COVID-19 infection and acute hypoxia (defined as PaO2/FiO2 below 350mmHg or PaO2/FiO2 below 280 on supplemental oxygen and immediately requiring high flow oxygen device or mechanical ventilation) and signs of systemic cytokine release syndrome characterized by high serum ferritin, or high D-dimers, or high LDH or deep lymphopenia or a combination of those, who have not been on mechanical ventilation for more than 24 hours before randomisation. Patients should have had a chest X-ray and/or CT scan showing bilateral infiltrates within the last 2 days before randomisation. Patients with active bacterial or fungal infection will be excluded.Intervention and Comparator: Patients will be randomized to 1 of 5 experimental arms versus usual care. The experimental arms consist of Anakinra alone (anti-IL-1 binding the IL-1 receptor), Siltuximab alone (anti-IL-6 chimeric antibody), a combination of Siltuximab and Anakinra, Tocilizumab alone (humanised anti-IL-6 receptor antibody) or a combination of Anakinra with Tocilizumab in addition to standard care. Patients treated with Anakinra will receive a daily subcutaneous injection of 100mg for a maximum of 28 days or until hospital discharge, whichever comes first. Siltuximab (11mg/kg) or Tocilizumab (8mg/kg, with a maximum dose of 800mg) are administered as a single intravenous injection immediately after randomization.Main Outcomes: The primary end point is the time to clinical improvement defined as the time from randomization to either an improvement of two points on a six-category ordinal scale measured daily till day 28 or discharge from the hospital or death. This ordinal scale is composed of (1) Death; (2) Hospitalized, on invasive mechanical ventilation or ECMO; (3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; (4) Hospitalized, requiring supplemental oxygen; (5) Hospitalized, not requiring supplemental oxygen; (6) Not hospitalized.Randomisation: Patients will be randomized using an Interactive Web Response System (REDCap). A 2x2 factorial design was selected with a 2:1 randomization regarding the IL-1 blockade (Anakinra) and a 1:2 randomization regarding the IL-6 blockade (Siltuximab and Tocilizumab).Blinding (masking): In this open-label trial neither participants, caregivers, nor those assessing the outcomes are blinded to group assignment.Numbers To Be Randomised (sample Size): A total of 342 participants will be enrolled: 76 patients will receive usual care, 76 patients will receive Siltuximab alone, 76 patients will receive Tocilizumab alone, 38 will receive Anakinra alone, 38 patients will receive Anakinra and Siltuximab and 38 patients will receive Anakinra and Tocilizumab.Trial Status: COV-AID protocol version 3.0 (15 Apr 2020). Participant recruitment is ongoing and started on April 4th 2020. Given the current decline of the COVID-19 pandemic in Belgium, it is difficult to anticipate the rate of participant recruitment.Trial Registration: The trial was registered on Clinical Trials.gov on April 1st, 2020 (ClinicalTrials.gov Identifier: NCT04330638) and on EudraCT on April 3rd 2020 (Identifier: 2020-001500-41).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. [ABSTRACT FROM AUTHOR]