Clinical Trials

The purpose of this study is to enumerate dendritic cells, to measure IFN-a production by pDC, and to measure cytokines, growth factors, proteins and metabolites/lipids, and to develop a predictive laboratory score for stratifying COVID-19+ individuals into subgroups with different prognoses and therapeutic needs. 

Plasmacytoid dendritic cells (pDCs) specialize in producing type I interferons (IFN-I). As such, they play an important role as an early line of defense against viral infections.

The majority of COVID-19+ individuals follow an uncomplicated course, with a smaller subset of patients requiring hospitalization or intensive care level support.

Early pDC enumeration in the peripheral blood and assessment of IFN-a could help predict outcomes of COVID-19+ individuals.

Additional assessment of cytokines, growth factors, proteins (including complement proteins, clotting factors, adhesion molecules, matrix proteins, receptors, lectins, and tissue injury factors) and metabolites/lipids in COVID-19+ individuals would enable an accurate understanding of the pathophysiology of different complications observed in patients infected with SARS-CoV-2 during the inflammatory state of the disease (e.g. myocarditis, acute renal disease, thrombosis).

As a part of the COVID-19 pandemic, Mayo Clinic Florida is utilizing remote monitoring technology to monitor non-ICU patients in order to identify patients who will need the ICU and prevent crashing patients on the floor. MCF is using approved InTouch video and Biofourmis remote vital sign monitoring technology, both used by Mayo Clinic in other capacities. This study will not be a study of the efficacy or the accuracy of these devices as they are already incorporated as standard of practice. This study will assess the reduction of on floor crashing patients, quality of care, and satisfaction of providers by using this technology.  

Understanding of how best to treat inflammatory bowel disease (IBD) has evolved over the last ten years. Evidence now suggests that the most effective therapy early in the course of Crohn's disease (CD) and ulcerative colitis (UC) involves the use of immune suppressing medications such as the anti-Tumor Necrosis Factor (anti-TNF) agents infliximab, adalimumab, and certolizumab. However, many CD and UC patients still ultimately require surgery despite the use of these medications. Side effects of the anti-TNF agents include increased risk of infections due to their effect on the immune system. Little is known about how use of these medications near the time of surgery may affect patients' risks of infection or other post-operative complications. The only available studies on this topic have given conflicting results. These studies have been limited by the fact that they have been small in size and retrospective. Retrospective studies primarily involve chart review as the method of identifying potential risk factors for infections and other complications after they have already occurred. This method limits both the type and quality of information/data that can be collected. The conflicting results have led to variance in practice patterns with regards to management of anti-TNF agents, the timing of surgery, and even the types of surgery.

By enrolling patients at the time of their surgery, collecting extensive information may be possible than previously studied on potential risk factors for both infectious and non-infectious complications following surgery. Risk factors to be studied will include individual patient characteristics, disease characteristics, surgical methods, novel characteristics of CT scans and MRIs and extensive medication exposures. The primary objective is to determine if exposure to anti-TNF agents prior to surgery increases the risk of infection post-operatively. And evaluate exposure to anti-TNF agents by both patient history of use and measurement of anti-TNF drug levels at the time of surgery. Monitoring of drug levels at the time of surgery has never been utilized in this way to evaluate the risk of anti-TNF agents in IBD. However, this has been done to assess the risk of other medications in different diseases.

If anti-TNF agents are found to pose a risk for infectious or non-infectious outcomes in IBD patients undergoing surgery, change maybe needed in the way these medications are used around the time of surgery. Additionally, by collecting comprehensive information on other potential risk factors besides medication use patients at greatest risk for bad outcomes can be identified and take protective measures when possible. The aims of this study address the CCFA challenge to better define the risks of medical and surgical therapies to improve the quality of care of IBD patients undergoing surgery.

The purpose of this research is to evaluate multiple new tests for detection of antibodies to SARS-CoV-2, the cause of COVID19, in blood samples.

The purpose of this study is to compare the concordance of nasopharyngeal and saliva samples using molecular polymerase chain reaction (PCR) testing (copying DNA smples).

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.

The purpose of this study is to test if senescent cells and their secretome contribute to Long-Hauler Syndrome and if a clinical trial of senolytic drugs, which selectively eliminate senescent cells, should be initiated. 

The purpose of this study is to prospectively clarify the long-term consequences of SARS-CoV-2 infection in the CNS with multi-modal magnetic resonance (MR) imaging tracking structural, microstructural, vascular and biochemical changes.

COVID-19 increases the risk of developing long-term inflammatory, neurodegenerative and cerebrovascular consequences.

An important means to control the COVID-19 pandemic is the rapid identification of infected individuals to allow quarantine and therapy to be promptly delivered.  At home testing will soon be available, but requires reagents and introduces a delay.  The possibility of combining a limited number of Mid-Turbinate (MT) nasal swab tests, Dried Blood Spot (DBS) serology, and smartphone-enabled electrocardiogram (ECG) tests may permit daily rapid, under one minute tests potentially, if this method proves to be effective. We plan to enroll 900 participants to determine if we can detect conversion in all modalities.

The purpose of this study is to understand when patients are shedding active COVID virus RNA as detectable by viral culture, and if there are any correlates of the cessation of active viral shedding, such as presence of certain immunoglobulins.

Additionally, this study will take a discovery approach to the immune response to better understand how the body recovers or worsens during disease, and if there are opportunities to use that knowledge to develop treatments.