Medical Student University of Central Florida College of Medicine Orlando, Florida, United States
Background: Cystic fibrosis (CF) is a genetic disorder of the CFTR chloride channel that leads to impaired mucus clearance in the airways, which leads to deteriorations in lung function and chronic infection. In the early stages of the COVID-19 pandemic, patients with CF were considered at risk for poor clinical outcomes due to their generally worsened respiratory function. Specific factors like reduced FEV1% were reported to be associated with poor outcomes. However, later studies have suggested that CF may not significantly worsen COVID-19 clinical outcomes. Overall, the role of CF in COVID-19 has not been well studied, particularly in pediatric patients. Objective: This study aims to evaluate the outcomes of pediatric CF patients infected with SARS-CoV-2, including outcomes for both CF and COVID-19. Design/Methods: IRB approval was obtained from the Nemours Childrens Hospital IRB in April 2023. Rely-upon IRB approval was also obtained from the University of Central Florida (UCF) IRB. Data will be collected retrospectively from Nemours EPIC EMR throughout 2023.
In this retrospective review, a cohort of pediatric patients with CF who were diagnosed with COVID-19 on or after March 2020 will be compared to two control cohorts of pediatric patients with either no history of COVID-19 or CF matched based on confounding factors. Data to be collected for each patient includes FEV1%, number of ER visits, number of hospitalizations, usage of oxygen therapy, and mortality. For the COVID-19 only comparison, data on usage of COVID-19 antivirals, usage of ventilators, and occurrences of MIS-C will be collected. For the CF only comparison, data on occurrences of CF pulmonary exacerbations will be collected.
Independent sample 2-variable t-testing and univariate binomial logistical regression testing will be used to test for significant differences in outcome for quantitative variable and dichotomous variable comparisons respectively. Significance level is set at 0.05 and power is set at 0.8 for all analyses. Power calculation is conducted with G*Power, and analysis is conducted with SPSS.
