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- and long-term impacts of respiratory viral illnesses (COVID-19 and non-COVID-19) in sarcoidosis. Methods and Analysis: Up to twenty clinical sites across the United States are participating in the recruitment of 2,000 patients for this observational, prospective study. To ensure that the study cohort is representative of the general sarcoidosis population, participating sites include those dedicated to reaching underrepresented minorities or patients from non-urban areas. Baseline data on demographic features, comorbidities, sarcoidosis characteristics, and pre-enrollment lung function will be captured at study entry. During this 3-year study, all acute respiratory infectious events (from SARS-CoV2 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 analyzed 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 IRB 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 three-year follow-up period and will be made available upon request.