Clinical Trials

The purposes of this study are to determine if patients treated with fluoroquinolone (FQ) antibiotics have depletion of mitochondrial DNA (mtDNA) in buccal swab samples, and whether the degree of depletion correlates with the likelihood of developing FQ-associated toxicity.

2nd arm - An additional group of patients will be enrolled if they previously received FQ antibiotics. appear to be symptomatic and have a previously collected muscle or nerve biopsy for clinical purposes available for this research study. 

The purpose of this study is to demonstrate that treatment of Invasive Candidiasis/ Candidemia with intravenous (IV) echinocandin followed by oral ibrexafungerp is non-inferior to IV echinocandin followed by oral fluconazole based on 30-day all-cause mortality (ACM).

Furthermore, to demonstrate that treatment of Invasive Candidiasis/ Candidemia with IV echinocandin followed by oral ibrexafungerp is non-inferior to IV echinocandin followed by oral fluconazole based on Global Response (clinical, radiological, and mycological response, as confirmed by the Data Review Committee [DRC]) at Day 14

The purpose of this study is to evaluate treatment of BK polyomavirus with the use of Brincidofovir. 

The purpose of this study is to propose a novel approach for development of biomarkers by studying differences that may exist between patients with infectious and neurodegenerative smell loss.

The purpose of the bacteriophage registry and biorepository is to centralize collections of human blood from Mayo Clinic patients receiving phage therapy. Laboratory testing from this study will be paired along with clinically significant data including medical history, bacterial infection types, inflammatory biomarkers, antibiotic resistance, and others. We believe that this registry and biorepository of samples will help scientists and clinicians discover answers to research questions related to antibiotic-resistant bacterial infections, and the role that phage therapy plays as a possible treatment.

The purpose of this study is to evaluate the real-world utilization of ceftolozane/tazobactam (C/T) and to assess patient outcomes.

The purpose of this study is to develop a test that can be used routinely to detect and identify Candida auris from surveillance skin swabs.

The aim of this pragmatic, randomized trial is to compare clinical outcomes between patients undergoing immediate endoscopic necrosectomy (direct endoscopic necrosectomy) compared to step-up endoscopic interventions in patients undergoing endoscopic therapy for infected necrotizing pancreatitis.

Acute pancreatitis has an annual incidence of 13-45 cases per 100,000 persons and is one of the most common gastrointestinal disorders requiring hospitalization worldwide. It leads to over a quarter of a million hospital admissions annually in the United States, and inpatient costs exceeding 2.5 billion US dollars. Pancreatic necrosis occurs as a consequence of severe acute pancreatitis in approximately 20% of patients. It can mature ...

The purpose of this study is to test (in 2 stages) the safety/tolerability, pharmacokinetics (how the body handles study drug) and pharmacodynamics (effects on the immune system and the virus) of the study drug ABBV-181 in HIV-1 infected participants undergoing antiretroviral therapy (ART) interruption.

The purpose of this study is to obtain a whole blood sample from which DNA will be extracted to study polymorphisms in immune response genes and other geneticvariants that may be associated with an increased risk of disease progression among individuals with infectious diseases of public health importance who are enrolled in qualifying INSIGHT studies.

The purpose of this study is to develop an advanced multiparametric liver magnetic resonance elastography (MRE) imaging technology for monitoring hepatic inflammation during direct acting antiviral (DAA) treatment, evaluation risks of severe liver injury, and HCC development.

The primary purpose of the study is to establish a long-term nationwide registry of patients undergoing treatment with antiviral therapies for chronic hepatitis C  at academic and community practices.

The purpose of this study is to determine the optimal dose of FLU-IGIV based upon evaluation of safety and pharmacokinetics in hospitalized patients with serious illness caused by laboratory-confirmed influenza A infection.
 

The purpose of this surveillance registry is to characterize the demographics, clinical features, outcomes, and resource utilization of children requiring hospitalization during a novel epidemic.

The purpose of this study is to evaluate the safety and effectiveness, as determined by 90-day incidence of mortality or transplant, for intravenous (IV) DUR-928 (30 mg or 90 mg) in subjects with severe alcohol-associated hepatitis, also known as severe alcoholic hepatitis, (AH) with pre-treatment Maddrey Discriminant Function (MDF) score ≥ 32 and MELD scores 21-30. Additionally, to evaluate the effectiveness, as determined by 90-day mortality and 28-day mortality with or without transplant for IV DUR-928 (30 mg or 90 mg) in subjects with severe AH.

The purpose of this study is to gain a better understanding of the presentation, diagnostics, disease course and treatment variations, as well as the factors that may influence features of neuro-invasive Coccidioidomycosis. 

The purpose of this trial is to examine the effect of Fecal Microbiota Transplantation (FMT) compared with Vancomycin for cure of recurrent C. diff infection (CDI) in solid organ transplant (SOT) recipients in a randomized, controlled clinical trial.

The purpose of this study is to determine differences in microbiota composition in volunteers with and without Rome IV defined Campylobacter jejuni PI-IBS, and to determine differences in peripheral metabolites, proteins and lipids in volunteers with and without Rome IV defined Campylobacter jejuni PI-IBS.

The purpose of this study is to evaluate the influenza vaccine effectiveness for preventing severe and life-threatening influenza-associated illness in children 6 months to 17 years of age.

The purpose of this study is to create a special preparation protocol for the vaginal and perineal area that would include an occlusive dressing over the anal orifice (Anal Occlusive Dressing-AOD). We do hypothesize that it would eliminate or significantly reduce cross contamination of the bowel content with the surgical site and hence reduce the risk of SSI.

The purpose of this trial is to evaluate the effectiveness, safety, and tolerability of a single oral administration of study drug CP101 for the prevention of recurrent Clostridioides difficile Infection (CDI) in adult patients.

This Phase 3 trial will be conducted in 2 parts: a randomized, double-blind, placebo-controlled trial arm (Part A) and an optional open-label treatment arm (Part B). After completing standard-of-care (SOC) CDI antibiotics for their most recent CDI recurrence, patients who meet all eligibility requirements will be randomized to receive either the study drug CP101 or placebo in Part A of the trial.  Patients will be evaluated for CDI recurrence and safety ...

The objectives of this study are to establish the dynamic changes in iron metabolism and circulating iron-regulatory immune cells in kidney transplant infection, and to determine quantitative changes in tissue levels of hepcidin and iron-regulatory macrophages in transplant biopsy and compare pyelonephritis case with control.

The purpose of this study is to extend the previous SERES-004 study in patients who had a recurrence of clostridium difficile infection within the first 8 weeks of participation.  

The purpose of this study is to demonstrate the efficacy and safety of RBX7455 (an oral microbiota based drug) for the treatment of recurrent clostridium difficile infection (CDI) in subjects who have had at least one recurrence after a primary episode (i.e., at least two episodes) and have completed at least two rounds of standard-of-care oral antibiotic therapy. Study subjects will have their diarrhea resolved, i.e., would be having less than 3 watery bowel movements at the time of study enrollment for 48 hours or more.

The purpose of this study is to validate the utility of disc space aspirate cell count and differential in the diagnosis of NVO in a large patient cohort, and propose an updated algorithm for the workup of Native Vertebral Osteomyelitis (NVO) based on disc space aspirate cell count and differential

This is a prospective, multicenter, randomized, double-blinded, placebo-controlled Phase 3 study of a microbiota suspension of intestinal microbes. Patients who have had at least two recurrences after a primary episode and have completed at least two rounds of standard-of-care oral antibiotic therapy or have had at least two episodes of severe CDI resulting in hospitalization within the last year may be eligible for the study. Subjects who are deemed failures following the blinded treatment per the pre-specified treatment failure definition may elect to receive an unblinded RBX2660 enema.

The purpose of this study is to evaluate microbiota suspension of intestinal microbes. Patients who have had at least one recurrence of Clostridium Difficile Infection (CDI) after a primary episode and have completed at least one round of standard-of-care oral antibiotic therapy or have had at least two episodes of severe CDI resulting in hospitalization may be eligible for the study. Subjects may receive a second RBX2660 enema if they are deemed treatment failures following the initial enema per the protocol-specified treatment failure definition.

The purpose of this study is to evaluate surgical sterility, the microbiome, and infections post mastectomy with immediate/tissue expander surgery by using OR camera recording, surgical site and/or microbiome analysis.

The purpose of this study is to assess the effectiveness and safety of NPC-21 when administered prophylactically to cytomegalovirus (CMV) seronegative patients receiving a first kidney transplant from a CMV seropositive donor.

The purpose of this study will evaluate the safety and effectiveness of VE303 for participants with recurrent Clostridium difficile infection (rCDI).

This study will evaluate efficacy and safety information about RBX2660 for the treatment of recurrent Clostridium difficile infection (CDI). Enrolled subjects will receive one treatment with RBX2660 (microbiota suspension).

To assess the safety and tolerability of RBX2660 in subjects with recurrent CDI who have had prior recurrent CDI that was resolved with antibiotic treatment.

The purpose of this study is to assess the outcome of prosthetic joint infection (PJI) treated with various therapeutic regimens using a prospective cohort study.

Compare Patient-Collected Saliva and Health Care Worker Collected Nasopharyngeal and Nasal Mid-Turbinate Swabs for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Detection by nucleic acid amplification testing (NAAT). All tests will be performed using previously-validated, EUA NAATs that are available in the Clinical Microbiology laboratory, including the Mayo Clinic laboratory developed test (LDT).

The purpose of this study is to determine the safety and feasibility of the POC AI-ECG’s ability to detect active SARS-Cov-2 infection in humans, and to determine specificity, sensitivity, and diagnostic accuracy of POC AI-ECG’s detection of human with COVID-19 when compared to a PCR test.

The primary objective of this study is to evaluate whether remdesivir (RDV, GS-5734™) reduces the composite risk of death or invasive mechanical ventilation (IMV) through Day 29 in participants with severely reduced kidney function who are hospitalized for coronavirus disease 2019 (COVID-19).

The purpose of this study is to collect residual (waste) blood, urine, and stool specimens remaining from clinician order testing and corresponding clinical and patient provided data from COVID-19 patients with confirmed or suspected infection with the novel SARS-CoV-2 virus to enable high quality research. 

The purpose of this study is to evaluate the safety and tolerability of ART24 after 7 or 28 days of daily administration in recently-cured C. diff infection subjects.

The purpose of this research is to evaluate the primary objectives of safety and effectiveness (rate of clinical cure) of 2 dosages of CRS3123 (200 mg and 400 mg) administered orally (po) twice daily (bid) and vancomycin administered 125 mg PO 4 times daily (qid) in adults > or equal to 18 years of age with a primary episode or first recurrence of CDI. The study will investigate the plasma concentrations and HRQoL outcomes of CRS3123 and additional efficacy endpoints as secondary objectives.

The purpose of this study is to confirm the effectiveness of RBX2660 as compared to a placebo in preventing recurrent episodes of Clostridium difficile Infection (CDI) through 8 weeks.

This study evaluates the efficacy of prophylaxis with oral vancomycin for preventing recurrent Clostridium difficile Infection (CDI) in patients who have experienced at least one CDI episode in the last 180 days and are receiving antibiotics for a non CDI condition. Participants will be randomized to receive either placebo or oral vancomycin in addition to their prescribed antibiotic therapy.

The study will involve administering the study drug as a single dose of study drug or placebo. This study is designed to demonstrate the superiority of the experimental drug versus placebo in adult patients with recurrent CDI.

The primary objective of this study is to evaluate the clinical effectiveness of different investigational therapeutics relative to the control arm in adults hospitalized with COVID-19 according to clinical status (8-point ordinal scale) at Day 8.

The purpose of this study is to to evaluate the analytical performance of the Cue Health rapid (25 minute) molecular test for SARS-CoV-2 RNA using the proprietary nasal sample wand, disposable cartridge, and reader being developed by Cue Health Inc.

The objectives of this study are to describe the incidence of COVID-related olfactory loss, to compare the effectiveness of acupuncture, steroid rinses, and olfactory training versus steroid rinses and olfactory training in the treatment of COVID-related olfactory loss, and to recommend a treatment paradigm for patients with COVID-related olfactory loss.

The purpose of this research repository is to prospectively collect research biospecimens and corresponding clinical and patient provided data from COVID-19 patients with confirmed infection with the novel SARS-CoV-2 virus to enable high quality research. 

The study seeks to understand the impacts the COVID pandemic has brought to the communities, how communities are coping and how we can build resilience to prepare for future health crises.

This is a phase 3, multi-center, randomized, double-blind, placebo-controlled multicenter study to evaluate the efficacy and safety of colchicine in adult patients diagnosed with COVID-19 infection and have at least one high-risk criterion. Approximately 6000 subjects meeting all inclusion and no exclusion criteria will be randomized to receive either colchicine or placebo tablets for 30 days.

The study seeks to understand the impacts the COVID pandemic has brought to the communities, how communities are coping and how we can build resilience to prepare future health crises.

Our group has explored the use of genomic RNA/phage display libraries derived from primary human malignant melanoma cells as a means of identifying antibody detectable targets on cancer cells (cancer vaccines or antibody guided therapeutics).  In this approach, we isolate and affinity-column immobilize the IgG fraction from patient serum before and after immune therapy for melanoma, and expose the immobilized antibodies to bacteriophage expressing approximately 2x109 overlapping cDNA sequences of paired (same patient derived plasma and cancer cells) melanoma genomic RNA.  Phage, expressing melanoma cDNA express the proteins/peptides on their capsid are “recognized” by the immobilized antibodies are retained in ...

Our group has explored the use of genomic RNA/phage display libraries derived from primary human malignant melanoma cells as a means of identifying antibody detectable targets on cancer cells (cancer vaccines or antibody guided therapeutics).  In this approach, we isolate and affinity-column immobilize the IgG fraction from patient serum before and after immune therapy for melanoma, and expose the immobilized antibodies to bacteriophage expressing approximately 2x109 overlapping cDNA sequences of paired (same patient derived plasma and cancer cells) melanoma genomic RNA.  Phage, expressing melanoma cDNA express the proteins/peptides on their capsid are “recognized” by the immobilized antibodies are retained in ...

The purpose of this study is to establish whether therapeutic-dose parenteral anticoagulation improves outcomes (reduces intubation or mortality) by 30 days after randomization.

The primary objective of Aim 1 of this study are to identify personal and social determinant of health-related key factors that present as a barriers to use of non-emergent telehealth care during the COVID-19 pandemic. Aim 1 will use a qualitative study design to understand the experiences of patients along with social determinants of health (SDOH). The results of the qualitative work will be used by the research team to design the survey for administration in Aim 2.

The primary objectgive of Aim 2 of this study is to assess personal and social determinants of health that are associated with patient’s decision ...

The purpose of this study is to characterize the mucosal microbiome in patients who have recently been treated for Clostridium-difficile Infection (CDI) in comparison to that of control population to determine the effect of the mucosal associated microbiome on outcome of CDI.

 

The purpose of this study is to characterize mucosal and luminal microbiome in patients diagnosed with Clostridium difficile infection (CDI), at the time of diagnosis and after treatment, to determine the effect of mucosa associated microbiome on outcome of CDI and the effect of antibiotic treatment on mucosa associated microbiome

This study will evaluate the efficacy of merimepodib (MMPD) administered orally every eight hours (q8h) for 10 days in adult patients with advanced COVID-19.

The purpose of this study is to examine the impact of the COVID-19 pandemic on the physical activity habits and well-being of the general public.

The Coronavirus (COVID-19) outbreak was officially declared a pandemic on March 11, 2020 by the World Health Organization (WHO). Since then, many countries have introduced 'Social Distancing' guidelines/rules as a means of helping to stop the spread of the virus. Due to the ‘Social Distancing’ guidelines, the general population may be experiencing more sedentary behaviors and physical inactivity. Sedentary behaviors and physical inactivity are both well-known modifiable risk factors for cardiovascular disease and all-cause mortality. Thus, although Social ...

Aim 1: Determine the basal profile of non-genomic factors in patients at the time of exposure to SARS-CoV-2 and correlate with the three clinical patient outcome categories (A, B, C) as observed through their clinical course. 

Hypothesis: Baseline cytokine (IL-1β, IL-6, IL-4, IL-10, IFN-g and TNF-a) and the immune cellular repertoire (helper/CD4+, cytotoxic/CD8+, T-regulatory cells, natural killer cells) constitute the inherent biologic immunity of an individual and underpins their vulnerability to SARS-CoV-2 infectivity and/or its subsequent sequalae. 

Aim 2: Investigate if mutations or polymorphisms in genes (CXCR6, ACE2 and SLC6A20) linked to SARS-CoV-2 correlates with the ...

The purpose of this study is compare high dose (69.6 mg/day) Zinc to multivitamin supplementation on immune health as used by primary health care staff and individuals over 50 years old identified, by hypothesis generated from observations among the pandemic to date, as being at risk populations to COVID-19. In order to ensure consistent nutritional supplementation, the PreserVision AREDS formulation gel tabs will be recommended for those randomized to Zinc and the Adult (under 50) Centrum formulation recommended for those randomized to multivitamin.

This study aims to evaluate each agent with respect to speed of recovery, mortality, illness severity, and hospital resource utilization. Each agent will be evaluated as add-on therapy to the standard of care (SoC) in accordance with national or local guidelines, which may include remdesivir. 

The purposes of this study are to prevent COVID-19 (CoV) disease complications by a 7 point score adapted from the World Health Organization (WHO) Ordinal Scale for Clinical Improvement of CoV, to evaluate safety and tolerability of Fisetin in this patient population, to reduce progression of severity of CoV infections with no, mild, or moderate to severe or critical symptoms (WHO/National Institutes of Health (NIH) Baseline Categorization), and to decrease senescent cells, inflammation, and physical dysfunction (frailty).

The purpose of this study is to validate the BinaxNOW™ COVID-19 Ag Card in the asymptomatic COVID-19 screening population.

The BinaxNOW™ COVID-19 Ag Card is a useful tool for the rapid detection of SARS-CoV-2 and screening for COVID-19 in both symptomatic and asymptomatic patient populations.

The purpose of this study is to identify SARS-CoV-2 peptides capable of being processed and presented by antigen presenting cells during viral infection, to test peptides for biologic/immunologic relevance in PBMCs from recovered COVID-19+ cases, and to perform in vivo infection studies in mice (ACE2 x HLA A2 transgenic) using individual peptide and/or peptide combinations with and without adjuvants to identify the optimal protective potential of the identified peptide/peptides against wild virus challenge.

The study is being done to identify how many Healthcare workers develop antibodies against the SARS-CoV 2 virus over a 6 month period

The purpose of this study is to evaluate approximately 15,000 health care workers at risk for being exposed to COVID-19. 

The purpose of this study is to develop algorithms that will enable earlier identification and testing triggers for COVID-19 in otherwise asymptomatic patients, and to identify baseline characteristics from patients that ultimately test positive for COVID-19 that may predict clinical trajectory during the evolution of disease.

The purpose of this study is to assess the experience of low income pregnant women at an inner-city health system with seeking and receiving care. 

Significant disparities in health care and birth outcomes are seen in the US during normal times. During COVID-19, limited access to health care resources, social distancing and stay at home orders, and shortages of food and other necessities may exacerbate these disparities. 

The purpose of this study is to explore lay understandings toward participating in and perceptions of consent to biospecimen research and valuation of genetics in SARS-COV-2 infection, testing, immunity, and vaccine development, to explore professional attitudes toward and perception of barriers and facilitators for implementating genetic technology to facilitate understanding of SARS-COV-2 infection and immunity, improvement and scale-up of testing, and vaccine development, and to identify ethical, social, and inter-professional aspects of microbial genetic technology implementation in population health surveillance, clinical test development, and vaccine research.We hypothesize that engagement with individuals whom directly experience and/or are impacted by the increasing use ...

The objectives of this study are to assess the impact of outreach by the FAITH! Program (an academic-community partnership) on implementation of emergency preparedness teams (EPTs) in African-American (AA) churches, to determine whether messaging delivered via social media and email channels are effective in distributing accurate information about COVID-19, and to evaluate the impact of the COVID-19 pandemic on AA churches.

The microbiome within the gut lumen has been found in prior studies to differ in individuals with C. difficile infection (CDI) in comparison to those without diarrhea. The microbiome associated with the mucosal surface on the colon has been noted to differ from that of the lumen in other clinical scenarios, although this has not been studied in depth in patients with CDI. The goal of this research is to characterize the mucosal microbiome in patients with CDI after treatment to characterize this microbiome and determine the effect on recurrence of CDI.

The general aim of this study is to estimate the rate of disease progression for adults who seek testing and test positive for SARS-CoV-2. The primary endpoint for this study and the basis for sample size is hospitalization or death during the 28 day follow-up period. In some locations, special facilities are being built/utilized for quarantine/public health reasons for those who are SARS-Cov-2 positive. Hospitalization is defined as a stay for at least 18 hours, irrespective of reason, at a hospital or one of these special facilities after study enrollment. Secondary outcomes include participant-reported health status and change in ...

The primary purpose of this study is to evaluate the ability of patients, who are not healthcare workers (HCWs) and have no prior training in swab collection, to collect, package, and ship their own self-collected MT swab specimens (both commercial and Mayo Clinic 3-D printed versions) by following written instructions.

The first aim of this study is to verify that the TCR beta sequencing and curation platforms we will be using are able to identify patients with severe COVID-19 based on the TCR repertoires. This may be accomplished by testing and analyzing results between two cohorts: patients presenting acutely to MCF with mild COVID-19 and patients presenting with severe COVID-19. This will be accomplished by utilizing the the immunoSEQ Human T-cell Receptor Beta (hsTCB) Assay (Adaptive Biothechnologies) and the publicly available ImmuneCODE Open Access Database to confirm previously published data (PMID: 34253751). Both procedures will be performed by the company that ...

The purpose of this study is to assess levels of caffeine intake among patients who tested positive for COVID-19 infection and compare that to disease severity.

The purpose of this study is to see if molecular methods can predict Helicobacter pylori antimicrobial resistance patterns and predictions agree with current gold standard antibacterial susceptibility testing (AST) agar dilution.  

The purpose of this study is to evaluate the effect of nirmatrelvir/ritonavir compared to placebo/ritonavir on SARS-CoV-2 viral RNA levels in NP swabs in hospitalized participants ≥ 12 years of age with severe COVID-19 who are immunocompromised or at increased risk for severe COVID-19 outcomes. Change from baseline in SARS-CoV-2 RNA level in NP swabs at Day 5. The difference between nirmatrelvir and placebo in mean change from baseline in SARS-CoV-2 RNA level in NP swabs 5 days after the start of treatment, regardless of intercurrent events, in the population of hospitalized patients ≥ 12 years of age with severe COVID-19 ...

The purpose of this study is to prospectively collect longitudinal stool specimens and corresponding clinical and patient provided data from asymptomatic patients or those with history of exposure or patients presenting with symptoms suggestive of COVID-19 who are undergoing testing for the novel SARS-CoV-2 virus to enable high quality research.

The purpose of this study is to compare ridinilazole with vancomycin as comparator to treat Clostridium difficile Infection (CDI) with the goal of achieving comparable cure rates to standard of care, but reducing rates of recurrent disease.

The purpose of this study is to perform independent analysis of optimal synovial fluid diagnostic cutoffs for acute periprosthetic joint infection of the knee.

The purpose of this study is to collect saliva specimens from individuals who tested positive for SARS-CoV-2 RNA in respiratory tract specimens to validate this specimen type for the SARS-Co-V-2 RNA Detection and Quantification digital droplet PCR-based assay, and to evaluate the use of SARS-CoV-2 viral load measured in saliva for correlation with levels in other specimen types, disease course, and/or response to therapy.

The purpose of this study is to evaluate the feasibility of a resiliency program to provide an effective and sustainable solution to several important problems experienced by medical professionals.

The purpose of this study is to compare cardiopulmonary exercise testing with no filter to pre- and post-flow sensor placement.

The purpose of this study is to evaluate the safety and tolerability of Acalabrutinib suspension when delivered via a nasogastric tube and co-administered with a Proton Pump Inhibitor, in the treatment of COVID-19.

The purpose of this study is to assess the effectiveness and safety of Human coronavirus immune plasma (HCIP) to reduce the risk of hospitalization or death, the duration of symptoms and duration of nasopharyngeal or oropharyngeal viral shedding.

The primary aim of this study is to determine if there is any evidence of viral shedding within the gastrointestinal or pulmonary system in patients with a prior recent negative nasopharyngeal PCR test. This will be of critical importance to the practice of endoscopy during this pandemic as it will help:  1) determine if a pre-endoscopy testing strategy is adequate to ramp-up access to semi-urgent and eventually elective procedures, while allowing the decreased utilization of limited or costly personal protective equipment (e.g., N95 respirators) while still keeping the GI endoscopy staff safe; and 2) realize the false negative rate of pre-procedural testing, which is vital to inform procedural practice policy and operations.  

The objectives of this study are to determine the prevalence of spike (S) protein antibodies in COVID-19 vaccinated individuals, to assess the role of age and gender in relation to the capacity of COVID-19 vaccinated individuals to develop S protein antibodies, and to identify microRNA (miRNA) in serum derived exosomes that correlates with S protein antibody development and determine how age and gender may affect the correlation B.

The specific aims of the study are to:

Aim 1. To determine the feasibility of a community-engaged research partnership to support rapid SARS-CoV-2 testing for symptomatic patients of all ages in the underserved population during the COVID-19 crisis. We will pilot a rapid testing strategy at OCHC using Mayo Clinic Laboratory (MCL) diagnostic processing.

Aim 2. Compare the effectiveness of community-driven messaging in increasing uptake of rapid SARS-CoV-2 testing compared with usual sources of health information. We will draw a simple random sample of OCHC patients (N=1000, age 18+) with 1:1 randomization of communication about COVID-19 ...

The purpose of this study is to correlate BAL CD8+ TRM cells and quantitative lung fibrosis scores in survivors of moderate-to-severe COVID-19 infection.

The purpose of this study is to determine if self-collected rectal and pharyngeal swabs for Chlamydia and Gonorrhea NAAT provide comparable results to provider-collected swabs and can be used in a clinical setting to offer testing vial a mail-in process.

We will be performing a largely descriptive study regarding awareness and implementation of SARS-CoV-2 transmission prevention behaviors as well as psychosocial outcomes and perceptions at baseline, 3 months, 6 months, and 1 year.  The study design will be a prospective cohort study of workers across devise workforce sectors and include a survey to be completed at each time point.

The purpose of this research is to evaluate a clinical assay designed to measure biomarkers that will help us understand COVID-19.

The primary aim of this study is to assess colon and rectal surgery patient perceptions of physical fitness, willingness to participate in a prehabilitation program, access to cardiovascular and strength training equipment, and impact of the COVID19 pandemic on fitness and health. The secondary aim is to evaluate if patient’s perceptions of physical fitness correlate with baseline demographic and health variables and outcomes following surgery.

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 ...

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 ...

The purpose of this study is to evaluate the effectiveness, safety, and tolerability of REGN10933+REGN10987 in hospitalized adult patients with COVID-19.

The purpose of this study is to evaluate the safety and effectiveness of VE303 for participants with primary C. difficile infection (pCDI) at high risk for recurrence or subjects with recurrent C. difficile infections (rCDI).

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 time to recovery of CPI-006 plus Standard of Care (SOC) versus placebo plus SOC in hospitalized participants with mild to moderately symptomatic Covid-19 infection.

This is a randomized, open label, adaptive platform trial to compare the effectiveness of antithrombotic strategies for prevention of adverse outcomes in COVID-19 positive inpatients

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).

The purpose of this study is to determine the safety of the SARS-CoV-2 vaccination in patients listed for solid organ transplantation, including heart, lung, liver, kidney, and pancreas.

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 ...

The purpose of this study is to evaluate the immune status of patients with Candida infection, particularly those that have infection that is difficult to treat. The study will also assess the role of interferon-gamma (a substance secreted by cells of the immune system).

This study aims to determine the effect of lingering COVID-19 symptoms on alveolar-capillary membrane conductance, pulmonary blood flow, exhaled nitric oxide, maximal respiratory pressures, lung clearance index and pulmonary function (flow rates, lung volumes, resistance, and reactance) and to examine the relationships between the respiratory physiology and exercise gas exchange between subjects with and without ongoing COVID-19 symptoms.

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. 

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.

The primary objective of this study is to evaluate the efficacy of 2 remdesivir (RDV) regimens compared to standard of care (SOC), with respect to the time to discharge in participants with moderate coronavirus disease (COVID-19).

The purpose of this study is to evaluate the efficacy of 2 remdesivir (RDV) regimens with respect to the normalization of temperature and oxygen saturation through Day 14 in participants with severe coronavirus disease (COVID-19).

The primary purpose of this study is to estimate the incidence rate of confirmed respiratory syncytial virus (RSV) (and other confirmed respiratory viruses) infections and associated adverse outcomes.

The purpose of this study is to evaluate the accuracy of the Luminex anti-SARS-CoV-2 IgG assay performed on self-collected dried blood spot samples collected pre- and post- SARS-CoV-2 vaccination.

The purpose of this study is to perform an ambi-directional clinical, neurological, cognitive, functional, and blood boimarker study of hospitalized patients with and without COVID-19.

The purpose of this study is to understand how transitioning to telework due to COVID-19 impacts employee satisfaction in one health care facility and how select non-clinical employees describe their experiences after transitioning from an in-person work environment to telework.

The primary purpose of this study is to assess the safety of clazakizumab treatment in COVID-19 infected patients with respiratory failure due to hyperinflammation related to cytokine storm.

The pupose of this study is to evaluate near-patient methods, including both point of care (POC) and patient-performed testing.

The purpose of this study is to establish whether patients with post-COVID syndrome have different serologic markers than control patients who have had COVID and recovered without progression to post-COVID syndrome.

The purpose of this study is to compare the efficacy and safety of maribavir to valganciclovir for the treatment of cytomegalovirus (CMV) infection in asymptomatic hematopoietic stem cell transplant recipients.

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.

The purpose of this study is to evaluate the impact of vagal nerve stimulation on symptom burden, neuroinflammatory change, and blood markers of inflammation in patients with post COVID syndrome who have fatigue and headache.

The purpose of this study is to assess the effectiveness of nebulized PC945 in combination with systemic antifungal therapy for the treatment of refractory Invasive Pulmonary Aspergillosis (IPA).

The purpose of this study is to examine the experiences of women and their partner seeking reproductive endocrinology and infertility (REI) care during the COVID-19 outbreak.

The purpose of this study is to develop algorithms that will enable earlier identification and testing triggers for COVID-19 in otherwise asymptomatic patients, and to identify baseline characteristics from patients who ultimately test positive for COVID-19 that may predict clinical trajectory during the evolution of disease.

The purpose of this study is assess the pharmacodynamics, pharmacokinetics, safety and effectiveness of two different doses of Tocilizumab (TCZ) in combination with Standard of Care (SOC) in hospitalized adult patients with moderate-to-severe COVID-19 pneumonia. 

The objectives of this study are to assess the ‘longer-term’ clinical, pulmonary, cardiac, functional, and psychosocial sequelae of COVID-19 survivorship, and to investigate whether exercise therapy enhances recovery of and/or improves pulmonary and cardiac function, exercise capacity, clinical status, and overall HRQoL in COVID-19 survivors.

The purpose of this study is to establish a registry that will follow patients that are seen in the PCCOC clinic with Post-COVID symptoms that persist for greater than 28 days. 

Patients with alpha-1 antitrypsin deficiency are prone to having an imbalance of lung Elastin degradation which render the patient's lung’s susceptible to inflammatory insults.  We have postulated that a severe COVID infection would accentuate this inflammatory imbalance and be more likely to lead the patient into a hospitalization event.  Our hypothesis would be to determine if this genetic mutation is found more frequently and patients who have been hospitalized with COVID.

The purpose of this study is to evaluate the effectiveness of an investigational drug called DAS181 compared to placebo in the treatment of PIV. 

The primary purpose of this study is to examine 1-year survival and rate of secondary infections in COVID-19 patients with and without acute kidney injury (AKI).

The purpose of this study is to evaluate the efficacy, safety, pharmacodynamics, and pharmacokinetics of tocilizumab (TCZ) compared with a matching placebo in combination with standard of care (SOC) in hospitalized patients with severe COVID-19 pneumonia.

The purpose of this study is to examine whether health coaching provides added benefit to usual care for patients with post COVID syndrome. 

The purpose of this study is to gain the perception of patients who have experienced long-haul COVID-19 and its manifestations. The objective of the study is to gather information to assist healthcare providers and future patients in understanding long-haul COVID-19 and its manifestations. perienced this phenomenon.

We hypothesize that cancer patients on cytotoxic chemotherapy which affect immune response may not mount adequate immune response to COVID-19 vaccines.

Aims, purpose, or objectives:

1. To determine the antibody response to COVID-19 vaccine after vaccination.
2. To assess the adverse events of COVID-19 vaccines in cancer patients.
3. To determine the incidence and severity of COVID-19 infection after the vaccination.

The purpose of this study is to look at the use of a novel biofeedback-assisted meditation device when used during the day to provide mindfulness training if it can increase calm state brain activity in post-Covid patients.

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 ...

The purpose of this study is to assess short- and long-term clinical outcomes and immune responses after SARS-CoV-2 infection and/or MIS-C in children (defined as individuals who have not yet reached their 21st birthday).  Participants will be identified through active recruitment measures within hospitals and through ambulatory and laboratory-based databases of SARS-CoV-2 positive children. 

This will be a prospective study of patients with IBD at Mayo Clinic initially in Jacksonville with possible subsequent extension to other Mayo sites.  We will evaluate the immunogenicity of commercially available COVID-19 vaccines and compare vaccine response among the groups based on their immunosuppressive regimens.  We will divide the immunosuppressive regimens into presumed high vaccine responders Group A and presumed low vaccine responders Group B. We will also assess for adverse reactions to the vaccine and compare with the reported rates in the clinical trials that led to approval of these vaccines.

The purpose of this study is to identify correlates of healthcare-seeking behavior in patients with ACS and CHF and its association with psychosocial and health outcomes.

The purpose of this study is to generate evidence demonstrating the domain specification (via modern psychometric methods), reliability, validity, and responsiveness (within-subject meaningful change) of the patient-reported outcome (PRO) endpoints.

The purpose of this study is to investigate the effectiveness and safety of Rivaroxaban for reducing the risk of major venous and arterial thrombotic events, hospitalization and death in medically ill outpatients with acute, symptomatic COVID-19 infection.

This study will be a retrospective and prospective analysis of patients with Post-COVID-19 symptoms that persist for greater than 28 days that are seen in the PCoCC (Post COVID Care Clinic), CARP, Pulmonary for post COVID clinic, Neurology,  or approval by the MAGPIES research group. 

Data for the registry will be aggregated from the EHR and by questionnaires. This data can be used to better guide strategic and tactical decisions as clinicians and healthcare managers respond to the rapidly evolving Post-COVID-19 patients.

The biobank will be optional for the participant and is designed to prospectively collect ...

This randomized phase III trial studies caspofungin acetate to see how it works compared to fluconazole in preventing invasive fungal infections in patients with acute myeloid leukemia who are undergoing chemotherapy. Caspofungin acetate or fluconazole may help prevent fungal infections caused by chemotherapy. It is not yet known whether fluconazole is more effective than caspofungin acetate in preventing fungal infections in patients with acute myeloid leukemia who are undergoing chemotherapy.

The purpose of this study is to compare a standard steroid dosing algorithm to a novel biomarker-tailored steroid dosing algorithm for patients receiving corticosteroids for community acquired pneumonia.  Patients with severe community acquired pneumonia may benefit from adjunctive corticosteroid therapy. The optimal patient selection, dosing and duration of steroids is unknown.

The study aims to characterize patient factors, such as pre-existing comorbidities, cancer type and treatment, and demographic factors, associated with short- and long-term outcomes of COVID-19, including severity and fatality, in cancer patients undergoing treatment. The study also is aimed to describe cancer treatment modifications made in response to COVID-19, including dose adjustments, changes in symptom management, or temporary or permanent cessation. Lastely, evaluate the association of COVID-19 with cancer outcomes in patient subgroups defined by clinico-pathologic characteristics.

The purpose of this study is to evaluate two different standards of care to see if the single Double Debridement, Antibiotics and Implant Retention (DAIR) protocol is non-inferior to planned double-DAIR protocols for acute Periprosthetic Joint Infection (PJI) after primary total hip arthroplasty (THA) or  total knee arthroplasty (TKA). Additionally, effectiveness of treatment in terms of infection eradication and cost comparisons will be addressed.

The purpose of this study is to evaluate the effectiveness of ALIS + azithromycin (AZI) + ethambutol (ETH) compared to the empty liposome control (ELC) + AZI + ETH on patient reported respiratory symptoms at Month 13.

The purpose of the study is to evaluate the microbiological response and clinical effectiveness of SPR720 compared with placebo in participants with nontuberculous mycobacteria pulmonary disease (NTM-PD). Additionally, to determine the safety and tolerability of SPR720 in a participants population with NTM- PD 3. Also, the pharmacokinetic (PK) of SPR719, active moiety, following orally (po) administered prodrug SPR720 in a participant population with NTM-PD.

The purpose of this study is to track the treatment burden experienced by patients living with Type 2 Diabetes Mellitus (T2DM) experience as they work to manage their illness in the context of social distancing measures. 

To promote social distancing during the COVID-19 pandemic, health care institutions around the world have rapidly expanded their use of telemedicine to replace in-office appointments where possible.1 For patients with diabetes, who spend considerable time and energy engaging with various components of the health care system,2,3 this unexpected and abrupt transition to virtual health care may signal significant changes to ...

The purpose of this study is to evaluate the effectiveness of inhaled molgramostim, administered open-label, to adult cystic fibrosis subjects with chronic pulmonary nontuberculous mycobacterial (NTM) infection, with or without ongoing antimycobacterial guideline based combination therapy.

This research trial will study the immune respone to COVID-19 vaccination in patients with rheumatic diseases.

This study aims to further understand the extent of long term effects of COVID-19 via batteries of self-assessment questionnaires focused on the most common complications of SARS-COVID 19 infections including respiratory and cardiovascular symptoms, frailty, fatigue, exercise capacity, cognitive and emotional functionality, and overall quality of life. Furthermore, we will investigate the impact of 4 weeks of respiratory muscle training and nasal breathing on the above mentioned long-term Covid-19 disease complications.

The purpose of this study is to understand the impact of the COVID pandemic on IBD patients, including infection rates and complications from SARS-COV2, IBD related flares, patient compliance with biologic agents, impact of lockdowns on access to IV infusion centers, need for steroid therapy and admissions for IBD related flares, and modification of medical management.

The purpose of this study is to evaluate the clinical and neurocognitive correlates of COVID-19 in patients with bipolar disorder (BD). 

The purpose of this study is to evaluate the role of interferon-gamma (IFN-γ) in antifungal defense and its potential use in adjunctive immunotherapy.  Solid organ transplant (SOT) and hematopoietic stem cell transplant (HSCT) recipients are at increased risk for invasive fungal infections.  Mortality rates remain unacceptably high despite antifungal treatment. Novel therapeutic modalities are urgently needed. In this project, we propose to study the role of interferon-gamma (IFN-gamma) in antifungal defense and its potential use in adjunctive immunotherapy. 

The purpose of this research is to determine if CGM (continuous glucose monitors) used in the hospital in patients with COVID-19 and diabetes treated with insulin will be as accurate as POC (point of care) glucose monitors. Also if found to be accurate, CGM reading data will be used together with POC glucometers to dose insulin therapy.

The purpose of this study is to determine whether a common virus, cytomegalovirus (CMV), may increase fatigue and other symptoms following treatment for ovarian cancer.  

This randomized phase III trial studies how well caspofungin acetate works compared to fluconazole or voriconazole in preventing fungal infections in patients following donor stem cell transplant. Caspofungin acetate, fluconazole, and voriconazole may be effective in preventing fungal infections in patients following donor stem cell transplant. It is not yet known whether caspofungin acetate is more effective than fluconazole or voriconazole in preventing fungal infections in patients following donor stem cell transplant.

The purpose of this study is to evaluate the safety and tolerability of PC945 for the prevention of fungal aspergillus infections in the lung in patients who have received a lung transplant.

The primary purpose of this study is to determine if the reduction in TMPRSS2 activity via direct inhibition with Camostat mesilate combined with standard of care (SOC) treatment will increase the proportion of patients alive and free from respiratory failure at Day 28 in SARS-CoV-2 as compared to SOC treatment with placebo.

The purpose of this study is to determine whether short-term treatment with Fisetin reduces the rate of death and long term complications related to COVID-19.

The purpose of this study is to compare prevalence of sleep apnea and sleep disturbance in post-COVID-19 infected patients who had been symptomatic to COVID negative participants as controls. A sleep testing device will assess for sleep disordered breathing and the results will be aggregated to compare if a significant increase (any difference) in the prevalence of sleep disordered breathing diagnosis between the two groups. Sleep questionnares data will be obtained. A second part of this study will involve using a Fitbit consumer wearable device to obtain sleep and activity data on participants for 2 months in duration. 

The purpose of this study is to assess the safety of PH FDC SC when administered at home by an HHNP. Patients will be assessed for safety by regular evaluation of AEs, vital signs, routine clinical laboratory tests (hematology, blood chemistry), LVEF assessments, and by physical examinations.

The purpose of this study is to remotely use the Ellipsis Health (EH) voice analysis technology to record the speech patterns and content of individuals with a recent diagnosis of Coronavirus-19 (COVID-19) presenting to the post-COVID-19 clinic at Mayo Clinic, to validate its use as a tool to screen for major depressive disorder (MDD) and generalized anxiety disorder (GAD) against gold-standard questionnaires used in clinical practice namely the PHQ-9 and GAD-7

The primary objective of the United States Food and Drug Administration (FDA) for this study is to demonstrate non-inferiority in subjects who received an allogeneic BMT for subjects randomized to Rezafungin for Injection compared to subjects randomized to the standard antimicrobial regimen (SAR) for fungal-free survival at Day 90 (±7 days).

The primary objective of the European Medicines Agency (EMA) for this study is to demonstrate superiority in subjects who received an allogeneic BMT randomized to Rezafungin for Injection compared to subjects randomized to the SAR for fungal-free survival at Day 90 (±7 days).

The primary objective of this study is to determine the immunogenicity of FDA approved COVID-19 vaccination in patients with hematologic malignancies.

Secondary objectives of this study are to assess the safety of FDA approved COVID-19 vaccination in patients with hematologic malignancies, analyze the kinetics of immunogenic response over time after receipt of the COVID-19 vaccination. compare the immunogenicity of different COVID-19 vaccinations that will be approved by the FDA, and analyze advanced flow immunophenotyping of innate and adaptive immune blood cells in all participants and correlate with response to vaccination.

The purpose of this study is to evaluate the effietiveness of remdesivir (RDV) in reducing the rate of of all-cause medically attended visits (MAVs; medical visits attended in person by the participant and a health care professional) or death in non-hospitalized participants with early stage coronavirus disease 2019 (COVID-19) and to evaluate the safety of RDV administered in an outpatient setting.