Analysis of the Feedback Digitization Needs in Higher Education: Experiences from Lockdown Education in the Netherlands and Germany

After some time of lockdown experiences, limited attention for feedback and the absence of feedback digitalization frameworks suggests rethinking traditional feedback practices toward post-pandemics digital/hybrid education. This research surveyed feedback digitalization needs in the context of online education in high education institutions in the Netherlands and Germany during the COVID-19 pandemic. The dimensions surveyed included preferences for feedback such as typology of feedback (e.g., cognitive, behavioral, etc.), formats (e.g., written, audio, video), online instruments, and features for communicating feedback. The results suggest that online instruments supporting features for effortless interactivity are among the highly preferred digital options for giving/receiving feedback. When given online, inclusive formats of feedback that inform learners not only about their own but also peer performance were also found to be among highly rated options. The increased need for inclusive feedback with peers, however, may also negatively affect students' mastery orientations. Thus, balancing online with offline approaches should also be recommended when considering feedback digitalization approaches. © 2023 by the authors.

Lament in the City

In January 2020, foreboding signs of what we now call the COVID-19 pandemic emerged as a threat to global public health, and within a month, fears of an outbreak in New York City were increasingly real. By mid-March 2020, New York City, where we are located, shut down. For a time, the city became the epicenter of this pandemic, bringing unspeakable loss of life. Hundreds of thousands of deaths from COVID-19 have been recorded in New York City, more than one out of five total deaths from the virus in the United States. Sustained by the Spirit is a project developed by City Seminary of New York to listen to what is taking place on the ground, particularly among African, Asian, and Latin American churches in our city during the COVID-19 pandemic. In this proposed paper, we will report on how churches are lamenting what has been lost, what they have missed, and how lament forms the seeds of a new social beginning. This is especially for new ministries mobilized to care for vulnerable populations, those facing job loss and economic precarity, and families caring for children home from school and parents working from home. We will also be reflecting on lament in our Harlem neighborhood, and the impact of losses. This also touches on the area of life, community, pastoral care, and cities. From the interviews and site visits, we developed case studies for a more detailed portrait of this sample of churches and pastoral ministry. With the killing of George Floyd, New York City has become a center of protest and lament, which has its own liturgical life. Instead of the singular COVID-19 pandemic, churches speak of the pandemic of racism as well, another layer of lament. Given that both the public health crisis and our research are still in process, we are not ready to state more than descriptive and emergent findings. However, facing new questions while amid change is a normative experience for the global churches of New York City. In our observation, they have adapted well, continuing to be innovative and agile out of necessity. The churches are making a difference in the everyday lives of New Yorkers, the very fabric and future of the city. And they are lamenting losses that continue to press upon the city. © The Editor(s) (if applicable) and The Author(s), under exclusive licence to Springer Nature Switzerland AG 2023.

COVID-19 VACCINES: ADVERSE EVENTS FOLLOWING IMMUNISATION

Patients rely on healthcare providers as their most credible and frequent source of vaccine information. It is therefore crucial that healthcare providers are informed and have evidence-based, objective and clear guidance on vaccine efficacy and specific adverse events following immunisation (AEFI). Reported serious AEFIs are extremely rare for the COVID-19 vaccines. This article discusses the main AEFIs attributed to COVID-19 vaccines, including neurological complications of Guillain-Barré syndrome (GBS) and acute transverse myelitis (ATM), thrombosis;cardiac complications, including myocarditis, pericarditis and cardiomyopathy;and allergic reactions such as anaphylaxis, urticaria and skin rashes. The benefits of COVID-19 vaccination outweigh the risks;however, it is important that healthcare providers are aware of the risks and know how to recognise and manage them.

Food insecurity in South Africa: evidence from NIDS-CRAM wave 5. (Special Issue: The impact of COVID-19 in South Africa: one year into the pandemic.)

This article presents the results of the five waves of the National Income Dynamics Study - Coronavirus Rapid Mobile Survey (NIDS-CRAM) on food security between May 2020 and May 2021. Despite significant investments in social protection, food insecurity and household and child hunger remained stubbornly high. We conclude that given the protracted nature of the pandemic, slow economic recovery, household and child hunger have stabilised at higher levels than before the pandemic. The phasing out of emergency relief coupled with the constrained economic situation, are some of the reasons why levels of food insecurity and hunger are likely to remain high in the near future. Strict lockdown regulations also reduced employment and income from informal economic activities. Social support for vulnerable individuals and households remain an urgent priority. Continuing support targeted at households with children is particularly important given the dire consequences of enduring hunger for stunting, and on children's long-term development.

Smoking and COVID-19 in patients with cancer: Novel analysis from CCC19 registry

Background: Patients (pts) with thoracic cancers have a high rate of hospitalization and death from COVID-19. Smoking has been associated with increased risk for severe COVID-19. However, there is limited data evaluating the impact of smoking recency on COVID-19 severity in pts with cancer. We aimed to characterize the clinical outcomes of COVID-19 based on the recency of smoking in pts with thoracic cancers (TC) and all other cancers (OC). Methods: Adult pts with cancer and lab-confirmed SARS-CoV-2 and smoking history recorded in the CCC19 registry (NCT0435470) were included. Pts were stratified by cancer type (TC or OC) and further stratified into subgroups based on the recency of smoking cessation: current smoker;former smokers who quit < 1 yr. ago;1-5 yr. ago;6-10 yr. ago;quit > 10 yr. ago;and never smoker. 30-day all-cause mortality was the primary endpoint. Secondary endpoints were any hospitalization;hospitalization with supplemental O2;ICU admission;and mechanical ventilation. Results: From January 2020 to December 2021, 752 pts from TC group and 8,291 pts from OC group met the inclusion criteria. 78% of patients in TC group ever smoked compared to 36% patients in the OC group. In both groups, the majority of never-smokers were females (70% and 60% in TC and OC respectively). The burden of smoking and the rate of pulmonary comorbidities (PC) was higher in the TC group (PC 22-69%) compared to OC group (PC 12-26%) across all smoking strata. Overall, 30-day all-cause mortality was 21% and 11% in pts with TC and OC respectively. Former smokers who quit < 1 year ago in TC group had the highest rate of mortality and severe COVID-19 outcomes. However, in the OC group, there was no consistent trend of higher mortality or severe COVID-19 outcomes in specific subgroups based on smoking recency. Conclusions: To our knowledge this is the largest study evaluating the effect of granular phenotypes of smoking recency on COVID-19 outcomes in pts with cancer. Recent smokers who quit < 1 year ago in TC group had the highest rate of mortality and severe COVID-19. Further analysis exploring the factors (e.g., smoking pack years) associated with severe outcomes in this subgroup is planned.

Post-acute sequelae of SARS-CoV-2 infection in patients with cancer

Background: Most patients with cancer and COVID-19 will survive the acute illness. The longer-term impacts of COVID-19 on patients with cancer remain incompletely described. Methods: Using COVID-19 and Cancer Consortium registry data thru 12/31/2021, we examined outcomes of long-term COVID-19 survivors with post-acute sequelae of SARS-CoV-2 infection (PASC aka “long COVID”). PASC was defined as having recovered w/ complications or having died w/ ongoing infection 90+ days from original diagnosis;absence of PASC was defined as having fully recovered by 90 days, with 90+ days of follow-up. Patients with SARS-CoV-2 re-infection and records with low quality data were excluded. Results: 858 of 3710 of included patients (23%) met PASC criteria. Median follow-up (IQR) for PASC and recovered patients was 180 (98-217) and 180 (90-180) days, respectively. The PASC group had a higher rate of baseline comorbidities and poor performance status (Table). Cancer types, status, and recent anticancer treatment were similar between the groups. The PASC group experienced a higher illness burden, with more hospitalized (83% vs 48%);requiring ICU (29% vs 6%);requiring mechanical ventilation (17% vs 2%);and experiencing co-infections (19% vs 8%). There were more deaths in the PASC vs recovered group (8% vs 3%), with median (IQR) days to death of 158 (120-272) and 180 (130-228), respectively. Of these, 9% were attributed to COVID-19;15% to both COVID-19 and cancer;15% to cancer;and 23% to other causes. Conversely, no deaths in the recovered group were attributed to COVID-19;57% were attributed to cancer;and 24% to other causes (proximal cause of death unknown/missing in 38% and 19%, respectively). Cancer treatment modification was more common in the recovered group (23% vs 18%). Conclusions: Patients with underlying comorbidities, worse ECOG PS, and more severe acute SARS-CoV-2 infection had higher rates of PASC. These patients suffered more severe complications and incurred worse outcomes. There was an appreciable rate of death in both PASC and non-PASC, with cancer the dominant but not only cause in fully recovered patients. Further study is needed to understand what factors drive PASC, and whether longer-term cancer-specific outcomes will be affected.

"Ocean Optimism" and Resilience: Learning From Women's Responses to Disruptions Caused by COVID-19 to Small-Scale Fisheries in the Gulf of Guinea

This study examines the response of women to disruptions caused by COVID-19 in small-scale fisheries (SSF) in the Gulf of Guinea (GOG). It interrogates the concept of resilience and its potential for mitigating women's vulnerability in times of adversity. We define resilience as the ability to thrive amidst shocks, stresses, and unforeseen disruptions. Drawing on a focus group discussion, in-depth interviews with key informants from Cote d'Ivoire, Ghana and Nigeria, and a literature review, we highlight how COVID-19 disruptions on seafood demand, distribution, labour and production acutely affected women and heightened their pre-existing vulnerabilities. Women responded by deploying both negative and positive coping strategies. We argue that the concept of resilience often romanticises women navigating adversity as having 'supernatural' abilities to endure disruptions and takes attention away from the sources of their adversity and from the governments' concomitant failures to address them. Our analysis shows reasons for "ocean optimism" while also cautioning against simplistic resilience assessments when discussing the hidden dangers of select coping strategies, including the adoption of digital solutions and livelihood diversification, which are often constructed along highly gendered lines with unevenly distributed benefits.

Exploring Health Experts' and Creative Communicators' Focus in Pandemic Video Communication: A Qualitative Study

Pandemic video communication aimed at the general public often lacks creativity and fails to reach large audiences. Yet, the scientific content should not be compromised by attempts to improve the creativity or reach. This study explores the processes utilised by various health experts and professional communicators when creating communication, to identify similarities and differences, and how pandemic video communication thus can be improved through an interdisciplinary approach. We interviewed 12 individuals from 6 different professional domains: health, public health, film/science communication, video journalism, advertising, and social media/YouTube. Semi-structured individual interviews were conducted using the same interview guide. The interview data were subjected to thematic analysis with both deductive and inductive coding, and the results were visualised in a bubble chart. Our study has highlighted both similarities and differences between health professionals and creative communicators relating to their creative processes and their approaches to pandemic video communication. We found that participants from health domains assigned great importance to and efforts on the content, but were unsure or lacked experience in how content is translated through form and creativity. Creative communicators, on the other hand, emphasise and specialise in form, yet depend on health professionals, experts, and scientists to provide and validate content. The key to improving pandemic-related video communication appears to lie in striking the right balance between high-quality and evidence-based content and creativity. This study found that both health professionals and creative communicators play crucial roles in reaching a solid end result, and we suggest a fusion model approach to interdisciplinary collaboration.

Shortcomings in Public Health Authorities' Videos on COVID-19: Limited Reach and a Creative Gap

Video communication has played a key role in relaying important and complex information on the COVID-19 pandemic to the general public. The aim of the present study is to compare Norwegian health authorities' and WHO's use of video communication during the COVID-19 pandemic to the most viewed COVID-19 videos on YouTube, in order to identify how videos created by health authorities measure up to contemporary video content, both creatively and in reaching video consumers. Through structured search on YouTube we found that Norwegian health authorities have published 26 videos, and the WHO 29 videos on the platform. Press briefings, live videos, news reports, and videos recreated/translated into other languages than English or Norwegian, were not included. A content analysis comparing the 55 videos by the health authorities to the 27 most viewed videos on COVID-19 on YouTube demonstrates poor reach of health authorities' videos in terms of views and it elucidates a clear creative gap. While the videos created by various YouTube creators communicate using a wide range of creative presentation means (such as professional presenters, contextual backgrounds, advanced graphic animations, and humour), videos created by the health authorities are significantly more homogenous in style often using field experts or public figures, plain backgrounds or PowerPoint style animations. We suggest that further studies into various creative presentation means and their influence on reach, recall, and on different groups of the population, are carried out in the future to evaluate specific factors of this creativegap. © Shortt, Smeets, Wiig, Berg, Lungu, Thune and Røislien.

Severe multisystem inflammatory syndrome (MIS-C/A) after confirmed SARS-CoV-2 infection: a report of four adult cases.

BACKGROUND: Multisystem inflammatory syndrome (MIS) triggered by a recent SARS-Cov-2 infection has been recognised worldwide. Although predominantly affecting children (MIS-C), similar presentations have been reported among adults (MIS-A). METHOD: A retrospective case series describing four critically ill patients with MIS-C/A diagnosed between January and April 2021 at Sahlgrenska University Hospital, Gothenburg, Sweden. Clinical presentation, laboratory and radiological findings, treatment and outcome are reported. RESULTS: Cases occurred in previously healthy patients with a history of laboratory-confirmed mild SARS-CoV-2 infection four to seven weeks earlier. The median age was 24 years (range 19-43) and 3/4 were male. All fulfilled suggested MIS-C/A criteria according to the US Centre for Disease Control and all required care at an intensive care unit. Treatment was initiated with intravenous immunoglobulin, interleukin-1-receptor antagonists, and pulse steroids in 3/4 cases which resulted in rapid clinical improvement. No severe complications were noticed in any case during a three-month follow-up period. CONCLUSION: MIS-C/A should be considered, irrespective of age, in patients with fever, hyperinflammation and multiple organ system involvements emerging weeks after COVID-19. Previously suggested treatment regimens for MIS-C seem to be applicable also for MIS-A.

COVID-19 vaccination and breakthrough infections in patients with cancer.

BACKGROUND: Vaccination is an important preventive health measure to protect against symptomatic and severe COVID-19. Impaired immunity secondary to an underlying malignancy or recent receipt of antineoplastic systemic therapies can result in less robust antibody titers following vaccination and possible risk of breakthrough infection. As clinical trials evaluating COVID-19 vaccines largely excluded patients with a history of cancer and those on active immunosuppression (including chemotherapy), limited evidence is available to inform the clinical efficacy of COVID-19 vaccination across the spectrum of patients with cancer. PATIENTS AND METHODS: We describe the clinical features of patients with cancer who developed symptomatic COVID-19 following vaccination and compare weighted outcomes with those of contemporary unvaccinated patients, after adjustment for confounders, using data from the multi-institutional COVID-19 and Cancer Consortium (CCC19). RESULTS: Patients with cancer who develop COVID-19 following vaccination have substantial comorbidities and can present with severe and even lethal infection. Patients harboring hematologic malignancies are over-represented among vaccinated patients with cancer who develop symptomatic COVID-19. CONCLUSIONS: Vaccination against COVID-19 remains an essential strategy in protecting vulnerable populations, including patients with cancer. Patients with cancer who develop breakthrough infection despite full vaccination, however, remain at risk of severe outcomes. A multilayered public health mitigation approach that includes vaccination of close contacts, boosters, social distancing, and mask-wearing should be continued for the foreseeable future.

Predictors of clinical decompensation in patients presenting with COVID-19 in an urban hospital health system

Introduction: Severe acute respiratory syndrome coronavirus 2 (SARSCoV- 2) has resulted in a pandemic which has infected more than 128 million people and led to over 2.8 million deaths worldwide. Although the introduction of efficacious vaccines has led to overall declines in the incidence of SARS-CoV-2 infection, there has been a recent increase in infections once more due to the appearance of mutant strains with higher virulence. It therefore remains vital to identify predictors of poor outcomes in this patient population. Purpose: The objective of our study was to identify predictors of prolonged hospitalization, intensive care unit (ICU) admission, intubation, and death in patients infected with SARS-CoV-2. Methods: We conducted a retrospective analysis of all patients hospitalized with SARS-CoV-2 at our health system that includes one tertiary care center and two community hospitals located in the Chicago metropolitan area. The main outcome was a composite endpoint of hospitalization >28 days, ICU admission, intubation, and death. Explanatory variables associated with the primary outcome in the bivariate analysis (p<0.05) were included in the multivariable logistic regression model. Statistical analysis was performed using IBM SPSS 25.0. Results: Between March 1, 2020 and May 31, 2020, 1029 patients hospitalized with SARS-CoV-2 were included in our analysis. Of these patients, 379 met the composite endpoint. Baseline demographics are described in Table 1. Of note, our cohort consisted of a predominantly minority patient population including 47% Hispanic, 17% African American, 16% Caucasian, and 16% other. In bivariate analysis, age, hypertension, tobacco and alcohol abuse, obesity, coronary artery disease, arrhythmias, valvular heart disease, dyslipidemia, hypertension, stroke, diabetes, documented thrombosis, troponin, CRP, ESR, ferritin, LDH, BNP, D-dimer >5x the upper limit of normal, lactate, and right ventricular outflow tract velocity time integral <9.5 were significant. After multivariable adjustment, explanatory variables associated with the composite endpoint included troponin (OR 2.36;95% CI 1.08-5.17, p 0.03), D-dimer (OR 1.5;95% CI 1.23-1.98, p<0.01, lactate (OR 1.58;95% CI 1.28-1.95, p<0.01), and documented thrombosis (OR 3.56;95% CI 1.30-8.70, p<.05). Race was not a predictor of poor outcomes in the bivariate or multivariate analysis (Table 2). Conclusions: In a large urban cohort with a predominantly minority population, we identified several clinical predictors of poor outcomes. Of note, race was not a predictor of the primary endpoint in this study. While recent literature has demonstrated worse outcomes among racial minorities infected with SARS-CoV-2, our data suggests these variations are related to social determinants of health rather than biologic causes. (Figure Presented).

Discriminatory accuracy of the SOFA score for determining clinical decompensation in patients presenting with COVID-19

Introduction: While the global dissemination of vaccines targeting the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has resulted in a decline in the incidence of infections, the case fatality rates have remained relative stable. A major objective of managing hospitalized patients with documented or suspected COVID-19 infection is the rapid identification of features associated with severe illness using readily available laboratory tests and clinical tools. The sequential organ failure assessment (SOFA) score is a validated tool to facilitate the identification of patients at risk of dying from sepsis. Purpose: The aim of this study was to assess the discriminatory accuracy of the SOFA score in predicting clinical decompensation in patients hospitalized with COVID-19 infection. Methods:We conducted a retrospective analysis at a three-hospital health system, comprised of one tertiary and two community hospitals, located in the Chicago metropolitan area. All patients had positive SARS-CoV-2 testing and were hospitalized for COVID-19 infection. The primary outcome was clinical decompensation, defined as the composite endpoint of death, ICU admission, or need for intubation. We utilized the most abnormal laboratory values observed during the admission to calculate the SOFA score. Receiver Operating Curves (ROC) were then constructed to determine the sensitivity and specificity of SOFA scores. Results: Between March 1st and May 31st 2020, 1029 patients were included in our analysis with 367 patients meeting the study endpoint. The median SOFA score was 2.0 IQR (Q1, Q3 1,4) for the entire cohort. Patients who had in-hospital mortality had a median SOFA score of 4.0 (Q1,Q3 3,7). In patients that met the primary composite endpoint, the median SOFA score was 3.0, IQR (Q1, Q3 2,6). The ROC was 0.776 (95% CI 0.746-0.806, p<0.01). Conclusion: The SOFA score demonstrates strong discriminatory accuracy for prediction of clinical decompensation in patients presenting with COVID-19 at our urban hospital system. (Figure Presented).

Preexisting autoantibodies to type I IFNs underlie critical COVID-19 pneumonia in patients with APS-1

Patients with biallelic loss-of-function variants of AIRE suffer from autoimmune polyendocrine syndrome type-1 (APS-1) and produce a broad range of autoantibodies (auto-Abs), including circulating auto-Abs neutralizing most type I interferons (IFNs). These auto-Abs were recently reported to account for at least 10% of cases of life-threatening COVID-19 pneumonia in the general population. We report 22 APS-1 patients from 21 kindreds in seven countries, aged between 8 and 48 yr and infected with SARS-CoV-2 since February 2020. The 21 patients tested had auto-Abs neutralizing IFN-a subtypes and/or IFN-;one had anti-IFN-beta and another anti-IFN-T, but none had anti-IFN-. Strikingly, 19 patients (86%) were hospitalized for COVID-19 pneumonia, including 15 (68%) admitted to an intensive care unit, 11 (50%) who required mechanical ventilation, and four (18%) who died. Ambulatory disease in three patients (14%) was possibly accounted for by prior or early specific interventions. Preexisting auto-Abs neutralizing type I IFNs in APS-1 patients confer a very high risk of life-threatening COVID-19 pneumonia at any age.

Sedation requirements and practices for mechanically ventilated critically ill COVID-19 patients

INTRODUCTION: Preliminary reports suggest that critically ill patients with SARS-CoV-2 (COVID-19) infection requiring mechanical ventilation may have markedly increased sedation needs compared with non-COVID-19 mechanically ventilated patients. This study examines the sedative practices for this patient population within multiple ICUs of a large academic medical center. METHODS: A retrospective cohort study of sedation practices for a sequential cohort of 86 critically ill, mechanically ventilated patients with COVID-19 during the first 10 days of mechanical ventilation across eight intensive care units at the Massachusetts General Hospital, Boston, MA. Data characterizing the sedative medications, doses, drug combinations, and duration of administration were collected daily and compared to published recommendations for critically ill patients without COVID-19. The association between drug doses, number of drugs administered, baseline patient characteristics, and inflammatory markers were investigated. RESULTS: Among the study cohort, propofol and hydromorphone were the most common initial drug combination, with up to 100% and 88% of patients receiving these medications on a given day. The doses of sedative and analgesic infusions increased over the study period, reaching or exceeding the upper limits of published guidelines for propofol (48% of patients), dexmedetomidine (29%), midazolam (7.7%), ketamine (32%), and hydromorphone (38%). The number of sedative and analgesic agents simultaneously administered increased over time, with > 50% of patients requiring 3 or more agents by day 2. Variables associated with this requirement were younger age, increased body mass index (BMI), increased ferritin, increased LDH, lower P/F ratio, and the use of neuromuscular blockade. CONCLUSIONS: Our study confirms the clinical impression of increased sedative requirements in critically ill, mechanically ventilated patients with COVID-19. The impact of increased sedation administration on clinical outcomes and the optimal sedation regimen for this patient population remains unknown and warrants further investigation.

Association of clinical factors and recent anticancer therapy with COVID-19 severity among patients with cancer: a report from the COVID-19 and Cancer Consortium.

BACKGROUND: Patients with cancer may be at high risk of adverse outcomes from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. We analyzed a cohort of patients with cancer and coronavirus 2019 (COVID-19) reported to the COVID-19 and Cancer Consortium (CCC19) to identify prognostic clinical factors, including laboratory measurements and anticancer therapies. PATIENTS AND METHODS: Patients with active or historical cancer and a laboratory-confirmed SARS-CoV-2 diagnosis recorded between 17 March and 18 November 2020 were included. The primary outcome was COVID-19 severity measured on an ordinal scale (uncomplicated, hospitalized, admitted to intensive care unit, mechanically ventilated, died within 30 days). Multivariable regression models included demographics, cancer status, anticancer therapy and timing, COVID-19-directed therapies, and laboratory measurements (among hospitalized patients). RESULTS: A total of 4966 patients were included (median age 66 years, 51% female, 50% non-Hispanic white); 2872 (58%) were hospitalized and 695 (14%) died; 61% had cancer that was present, diagnosed, or treated within the year prior to COVID-19 diagnosis. Older age, male sex, obesity, cardiovascular and pulmonary comorbidities, renal disease, diabetes mellitus, non-Hispanic black race, Hispanic ethnicity, worse Eastern Cooperative Oncology Group performance status, recent cytotoxic chemotherapy, and hematologic malignancy were associated with higher COVID-19 severity. Among hospitalized patients, low or high absolute lymphocyte count; high absolute neutrophil count; low platelet count; abnormal creatinine; troponin; lactate dehydrogenase; and C-reactive protein were associated with higher COVID-19 severity. Patients diagnosed early in the COVID-19 pandemic (January-April 2020) had worse outcomes than those diagnosed later. Specific anticancer therapies (e.g. R-CHOP, platinum combined with etoposide, and DNA methyltransferase inhibitors) were associated with high 30-day all-cause mortality. CONCLUSIONS: Clinical factors (e.g. older age, hematological malignancy, recent chemotherapy) and laboratory measurements were associated with poor outcomes among patients with cancer and COVID-19. Although further studies are needed, caution may be required in utilizing particular anticancer therapies. CLINICAL TRIAL IDENTIFIER: NCT04354701.