Tab Title Description
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
- Rochester, Minnesota: 20-003364
About this study
Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The disease was first identified in 2019 in Wuhan, China, and has since spread globally resulting in over 1 million confirmed cases in the US and 81,000 deaths to date. While the majority of cases result in mild symptoms, some progress to pneumonia and multi-organ failure, challenging our hospital capacity and available medical staff. Current estimates of confirmed COVID-19 cases miss those who have recovered from infection prior to widespread testing, those with mild or no symptoms, and those with symptoms who have not been tested due to limited availability of testing. Thus, the true prevalence of COVID-19 infections in the US, Minnesota, and our surrounding community is unknown. Antibodies to SARS-CoV-2 in the blood indicate that someone has been infected with the virus and developed an immune response. Whether or not these individuals are protected from re-infection and how long this protection (if it exists) lasts are still unknown.
Further, a number of persons are at higher risk of infection compared to the general population due to greater exposure to COVID-19. In particular, first responders, persons working in long term care facilities that have had outbreaks of COVID-19, and day care providers. Understanding rates of asymptomatic infections, rates of seroconversion, and risk of re-infection in these groups will be critical to understanding protective immunity. In addition, this information will help inform public health measures to better isolate and prevent spread of COVID-19 in these settings in the future.
To address these questions, we propose two surveillance studies of SARS-CoV-2 in the general population and high risk settings to estimate the extent of SARS-CoV-2 infections in our surrounding community. We propose to use CLIA approved tests to identify serum antibodies to SARS-CoV-2 to identify past infection.