Background
sore throat, nausea or vomiting, aches, fever, fatigue, diarrhea, loss of taste or smell, congestion, skin rash, dry cough, Infection, headache, deaths, chills, coronavirus disease 2019, shortness of breath
SORE THROAT, CORONAVIRUS DISEASE 2019, DISEASE, OTHER VIRAL INFECTION, CONGESTION, DISEASE, INFECTION
According to the Centers for Disease Control and Prevention (CDC), as of September 2022, there were > 95 million total cases of coronavirus disease 2019 (COVID-19) in the United States and 1 million deaths [Some of the symptoms associated with COVID-19 include fever or chills, dry cough, shortness of breath, fatigue, muscle or body aches, headache, loss of taste or smell, sore throat, congestion or runny nose, red eyes, skin rash, discoloration of fingers or toes, nausea or vomiting, and diarrhea [The patient experience with COVID-19 varies across individuals and differs from other viral infections in terms of types of symptoms and their severity, with patients experiencing a range of respiratory, neurologic, gastrointestinal, circulatory, and musculoskeletal symptoms [At the time of this study, no COVID-19–specific PRO measures were published, and few have been developed to date [The purpose of this study was to perform a psychometric evaluation of the Symptoms of Infection with Coronavirus-19 (SIC), a PRO measure designed to assess the presence and severity of signs and symptoms of COVID-19. To be appropriate for use in both vaccine and treatment clinical studies, we sought to create a measure that was sensitive to both disease onset and changes in key signs and symptoms of COVID-19 using best practices in alignment with current regulatory guidance [