Rationale and design of the SARCoidosis Outcomes in all respiratory Viral Infectious Diseases (SARCOVID) Study.

INTRODUCTION: Respiratory infections are ubiquitous. The COVID-19 pandemic has refocused our attention on how morbid and potentially fatal they can be, and how host factors have an impact on the clinical course and outcomes. Due to a range of vulnerabilities, patients with sarcoidosis may be at higher risk of poor outcomes from respiratory infections. The objective of the SARCoidosis Outcomes in all respiratory Viral Infectious Diseases (SARCOVID) Study is to determine the short-term and long-term impacts of respiratory viral illnesses (COVID-19 and non-COVID-19) in sarcoidosis. METHODS AND ANALYSIS: Up to 20 clinical sites across the USA are participating in the recruitment of 2000 patients for this observational, prospective study. To ensure that the study cohort is representative of the general population with sarcoidosis, participating sites include those dedicated to reaching under-represented minorities or patients from non-urban areas. Baseline data on demographic features, comorbidities, sarcoidosis characteristics and pre-enrolment lung function will be captured at study entry. During this 3-year study, all acute respiratory infectious events (from SARS-CoV-2 and any other respiratory pathogen) will be assessed and recorded at quarterly intervals. The level of required medical care and survival outcomes determine infection severity, and the impact of infection on quality of life measures will be recorded. Post-infection lung function and imaging results will measure the long-term impact on the trajectory of sarcoidosis. Patients will be analysed according to the clinical phenotypes of cardiac and fibrotic pulmonary sarcoidosis. Control groups include non-infected patients with sarcoidosis and patients with non-sarcoidosis interstitial lung disease. ETHICS AND DISSEMINATION: Each site received local institutional review board approval prior to enrolling patients, with the consent process determined by local institution standards. Data will be published in a timely manner (goal <12 months) at the conclusion of the 3-year follow-up period and will be made available upon request.

Construction and Validation of a Scale to Measure Loneliness and Isolation During Social Distancing and Its Effect on Mental Health.

A variety of factors contribute to the degree to which a person feels lonely and socially isolated. These factors may be particularly relevant in contexts requiring social distancing, e.g., during the COVID-19 pandemic or in states of immunodeficiency. We present the Loneliness and Isolation during Social Distancing (LISD) Scale. Extending existing measures, the LISD scale measures both state and trait aspects of loneliness and isolation, including indicators of social connectedness and support. In addition, it reliably predicts individual differences in anxiety and depression. Data were collected online from two independent samples in a social distancing context (the COVID-19 pandemic). Factorial validation was based on exploratory factor analysis (EFA; Sample 1, N = 244) and confirmatory factor analysis (CFA; Sample 2, N = 304). Multiple regression analyses were used to assess how the LISD scale predicts state anxiety and depression. The LISD scale showed satisfactory fit in both samples. Its two state factors indicate being lonely and isolated as well as connected and supported, while its three trait factors reflect general loneliness and isolation, sociability and sense of belonging, and social closeness and support. Our results imply strong predictive power of the LISD scale for state anxiety and depression, explaining 33 and 51% of variance, respectively. Anxiety and depression scores were particularly predicted by low dispositional sociability and sense of belonging and by currently being more lonely and isolated. In turn, being lonely and isolated was related to being less connected and supported (state) as well as having lower social closeness and support in general (trait). We provide a novel scale which distinguishes between acute and general dimensions of loneliness and social isolation while also predicting mental health. The LISD scale could be a valuable and economic addition to the assessment of mental health factors impacted by social distancing.

Restarting Respiratory Clinical Research in the Era of the Coronavirus Disease 2019 Pandemic.

The clinical research we do to improve our understanding of disease and to develop new therapies has temporarily been delayed as the global health-care enterprise has focused its attention on those impacted by coronavirus disease 2019 (COVID-19). Although rates of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection are decreasing in many areas, many locations continue to have a high prevalence of infection. Nonetheless, research must continue and institutions are considering approaches to restarting non-COVID-related clinical investigation. Those restarting respiratory research must navigate the added planning challenges that take into account outcome measures that require aerosol-generating procedures. Such procedures potentially increase risk of transmission of SARS-CoV-2 to research staff, use limited personal protective equipment, and require conduct in negative-pressure rooms. One must also be prepared to address the potential for COVID-19 resurgence. With research subject and staff safety and maintenance of clinical trial data integrity as the guiding principles, here we review key considerations and suggest a step-wise approach for resuming respiratory clinical research.

Association of inhaled and systemic corticosteroid use with Coronavirus Disease 2019 (COVID-19) test positivity in patients with chronic pulmonary diseases.

BACKGROUND: The effects of chronic inhaled and systemic corticosteroids use on COVID-19 susceptibility and severity are unclear. Since many patients with chronic pulmonary diseases rely on corticosteroids to control disease, it is important to understand the risks of their use during the pandemic. We aim to study if the use of inhaled or systemic corticosteroids affects the likelihood of developing COVID-19 infection. METHODS: We used the National Jewish Health electronic medical record research database to identify a cohort of all subjects who were tested for suspected COVID-19 between March 11 - June 23, 2020. Testing results, medication use, and comorbidities were obtained from the medical record. Following a comparison of different propensity score weighting methods, overlap propensity score weighting was used to analyze the association between medication use and COVID-19 diagnosis. RESULTS: The cohort consisted of 928 patients, of which 12% tested positive. The majority (66%) of patients had a history of chronic pulmonary diseases. There was no significant association between inhaled corticosteroid use and testing positive for COVID-19. Interestingly, systemic corticosteroid use was associated with a lower odds ratio (0.95, 95% CI: 0.91-0.99) of testing positive for COVID-19. Similar results were noted when the analysis was restricted to those with any chronic pulmonary diseases, with asthma or with chronic obstructive pulmonary disease (COPD). CONCLUSIONS: Our study supports the recommendation that patients with chronic pulmonary diseases, including asthma and COPD who require treatment with either inhaled or systemic corticosteroids, should continue their use during the COVID-19 pandemic.

How to Leverage Collaborations Between the BME Community and Local Hospitals to Address Critical Personal Protective Equipment Shortages During the COVID-19 Pandemic.

The global COVID-19 pandemic disrupted supply chains across the world, resulting in a critical shortage of personal protective equipment (PPE) for frontline healthcare workers. To preserve PPE for healthcare providers treating COVID-19 positive patients and to reduce asymptomatic transmission, the Department of Bioengineering at the University of Colorado, Denver | Anschutz Medical Campus collaborated with National Jewish Health to design and test patterns for cloth face coverings. A public campaign to sew and donate the final pattern was launched and over 2500 face coverings have been donated as a result. Now that nearly three million cases of COVID-19 have been confirmed in the United States, many state and local governments are requiring cloth face coverings be worn in public. Here, we present the collaborative design and testing process, as well as the final pattern for non-patient facing hospital workers and community members alike.