Coronavirus disease 2019 (COVID-19)

Displaying 109 studies

  • Infusing Social Learning Theory into Online Education Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN

    Medical education and continuous professional development (CPD) are effective when it demonstrates translation of learning to clinical practice. The severe acute respiratory syndrome coronavirus 2 (COVID-19) pandemic has changed the landscape of CPD as in-person meetings and the associated social networking that occurs through these interactions has now largely disappeared. Limited data exists to guide the integration of social learning into online education; this study seeks to increase understanding of the impact of social learning on online education. The theory of planned behavior (TPB) will be used as a framework to evaluate impact.

    • AIM 1: ...

  • Losartan for Outpatients on COVID-19 Rochester, MN

    This is a multicenter randomized controlled trial comparing losartan vs placebo for outpatients with COVID. Every patient that is tested in the ED and drive through clinic will receive a brochure with information about the study. COVID positive will be called, and will receive supplies (medication, thermometer and swabs) at home.

  • A Study to Generate Algorithms for Early Prediction of Aggressive Progression and Hospitalization in Patients Diagnosed with SARS-CoV-2/COVID-19 Infection Rochester, MN

    The purpose of this study is to observe participants who have tested positive for COVID-19 using Current Health AI to learn about the disease.

  • A Study to Measure SARS-CoV-2 RNA in Human Saliva Rochester, MN

    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.

     

  • A Study to Evaluate a Resiliency Program for Healthcare Professionals During a Pandemic Rochester, MN

    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.

  • A Study to Compare Saliva and Swab Specimens in Detection of COVID Severe Acute Respiratory Syndrome Rochester, MN

    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).

     

     

     

     

  • COVID-19 Residual Biobank (Enrolling by Invitation Only) Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL

    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. 

     

  • A Study to Evaluate Rapid Throughput Screening for Human COVID-19 Infection Rochester, MN; Jacksonville, FL; Scottsdale/Phoenix, AZ

    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.

     

  • Study to Evaluate the Effectiveness and Safety of Remdesivir in Participants with Severely Reduced Kidney Function Who Are Hospitalized for Coronavirus Disease 2019 Jacksonville, FL; Rochester, MN

    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).

  • T Cell Response to COVID19 Vaccinated Individuals Jacksonville, FL; Rochester, MN

    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 ...

  • A Study to Learn About the Medicine Called Nirmatrelvir Used in Combination With Ritonavir in People with Weakened Immune Systems or at Increased Risk for Poor Outcomes who are Hospitalized Due To Severe COVID-19 Jacksonville, FL

    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 ...

  • A Study to Compare Nasal Swabs to Detect Severe Acute Respiratory Syndrome Coronavirus 2 Rochester, MN

    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.

  • Evaluation of the Effects of Caffeine, Via the ACE2 Receptor, on Clinical Severity of COVID-19 Disease Jacksonville, FL

    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.

  • A Study to Assess International SARS-CoV-2 (COVID-19) Infection Rochester, MN

    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 ...

  • Mayo Clinic COVID-19 Pandemic Response Stool Biobank (Prospective) Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL

    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.

  • A Study to Evaluate COVID19 Pregnancy Risks Rochester, MN

    It is unclear if and how COVID19 can be passed from mother to child. Therefore, we aim to collect maternal and fetal samples from COVID19-infected pregnant women and compare them to pregnant women who have clinical indications for COVID 19 testing at the time of hospital admission but end up being COVID19- (control group). Pregnant women who are either COVID19+ or COVID19- with symptoms will be followed during this study. Our objective is to understand the prevalence of maternal fetal transmission, risk factors and outcomes of a COVID19+ pregnancy, and how the virus can be passed from mother to baby ...

  • Emergency Preparedness and Risk Communication Among African-American Churches: Leveraging a Community-Based Participatory Research Partnership Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN

    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.

  • A Study to Analyze Algorithms for Evaluating Early Detection of SARS-CoV/COVID-19 Infection in Critical Service Employees Rochester, MN

    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.

     

  • Acknowledging diSParities In pRegnancy carE during COVID-19 Rochester, MN; Jacksonville, FL

    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. 

  • A Study to Evaluate the Pandemic Response Optimizing Technology and Ethics for Coronavirus Teams Implementing Novel Genetics Rochester, MN

    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 ...

  • Development of Potential COVID-19 Vaccine and Serological Assay Rochester, MN

    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 ...

  • A Study to Evaluate AntiThrombotic Therapy to Lessen Complications of COVID-19 (Enrolling by Invitation Only) Rochester, MN

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

  • Communities During COVID – Focus Groups Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN

    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.

  • A Study to Evaluate the Efficacy and Safety of Colchicine on Coronavirus SARS-CoV2 Positive Adults Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL

    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.

  • NSITE: Novel Strategies to Increase Telehealth Engagement Eau Claire, WI; Rochester, MN

    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 ...

  • Antibodies against COVID (enrolling by invitation) Rochester, MN

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

  • Healthcare Worker Exposure Response and Outcomes of Hydroxychloroquine Rochester, MN

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

  • Development of a Peptide-Based SARS-CoV-2 Candidate Vaccine Rochester, MN

    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.

     

     

     

  • BinaxNow™ Rapid Test Rochester, MN

    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.

     

  • A Study to Establish An Integrated Biomarker Panel for COVID-19 Infection Risk and Severity Prediction Jacksonville, FL; Rochester, MN

    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 ...

  • A Study to Evaluate Agents to Treat Moderately or Severely Ill Patients with Severe Acute Respiratory Syndrome Coronavirus 2 Rochester, MN

    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 COVID-19-PAWS project Rochester, MN; Scottsdale/Phoenix, AZ

    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 ...

  • A Study to Evaluate Fisetin to Alleviate Dysfunction and Inflammation in COVID-19 Subjects Rochester, MN

    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).

  • A Study to Evaluate the Effectiveness of Merimepodib in Adult Patients with Advanced COVID-1 Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL

    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.

  • A COVID Study to Compare Impact of Zinc Supplementation versus Multivitamin to Support Immune Health Rochester, MN; Scottsdale/Phoenix, AZ; Jacksonville, FL

    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.

  • A Study to Evaluate the Cue COVID Rapid Test Rochester, MN

    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.

  • COVID-19 Biobank Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN

    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. 

  • ACTIV-5 / Big Effect Trial (BET-B) for the Treatment of COVID-19 Jacksonville, FL; Rochester, MN

    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.

     

     

  • A Study to Evaluate Key Impacts on Communities During COVID Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN

    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.

  • Acupuncture Therapy for COVID-Related Olfactory Loss Rochester, MN

    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.

     

  • COVID-19 Cytokine Assay Rochester, MN

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

  • COVID19 Immunology and Omics Study Rochester, MN

    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 ...

  • Evaluation of patients perceived health and fitness prior to surgery during the COIVD 19 pandemic Rochester, MN

    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.

  • A Study to Assess the Safety, Tolerability and Effectiveness of Monoclonal Antibodies to Treat Hospitalized Patients with COVID-19 Rochester, MN

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

  • COVID-19 Remote Monitoring Jacksonville, FL

    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 ...

  • Working During the COVID-19 Pandemic Rochester, MN

    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.

     

     

  • COVID Controls Rochester, MN

    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.

  • A Study to Evaluate the Safety and Effectiveness of Antithrombotics to Treat Hospitalized COVID-19 Patients Scottsdale/Phoenix, AZ

    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

  • A Study to Evaluate COVID-19 Testing Using Saliva Jacksonville, FL

    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).

  • COVID-19 Serological Assay Validation Rochester, MN

    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.

  • Cellular Senescence and COVID-19 Long-Hauler Syndrome Rochester, MN

    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. 

  • A Study to Evaluate COVID-19 Testing Using Saliva Jacksonville, FL

    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).

  • COVID-19 Serological Assay Validation Rochester, MN

    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.

  • A Study to Evaluate the Safety of the SARS-CoV-2 Vaccination in Patients Waitlisted for Solid Organ Transplantation Jacksonville, FL

    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.

     

  • COVID in the Community (Enrolling by Invitation Only) Rochester, MN

    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 ...

  • A Study to Evaluate COVID Brain Advanced Imaging Network Rochester, MN

    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.

  • Vagal Nerve Stimulation for Post-COVID Fatigue Rochester, MN

    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.

  • Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Moderate Coronavirus Disease (COVID-19) Compared to Standard of Care Treatment (enrollment by invitation only) Rochester, MN

    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).

  • Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Severe Coronavirus Disease (COVID-19) (enrollment by invitation only) Rochester, MN

    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).

  • Dried Blood Spot COVID-19 Vaccination Response (Enrolling by Invitation Only) Rochester, MN

    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.

     

  • A Study to Evaluate Clazakizumab in Patients with Life-threatening COVID-19 Infection (Enrolling by Invitation Only) Scottsdale/Phoenix, AZ

    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.

  • Home Screening for COVID-19 Rochester, MN

    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.

  • A Study to Assess the Culture, PCR, Serology and Symptoms of COVID-19 Scottsdale/Phoenix, AZ

    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.

     

  • Long-term Effects of SARS-CoV-2 Jacksonville, FL

    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.

     

     

     

  • Teleworking in the Health Care Industry Due to COVID-19 Rochester, MN

    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.

  • A Study to Evaluate Near-Patient Tests for the Direct Detection of SARS-CoV-2 Scottsdale/Phoenix, AZ

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

  • Prevalence and Predictors of Spike Protein Antibodies in COVID-19 Vaccinated Individuals Jacksonville, FL

    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.

  • A Study to Compare COVID-19 Nasal Testing to Gastric, Bile, or Intestinal Testing Rochester, MN

    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.  

  • A Study to Evaluate Effectiveness and Safety of Lenzilumab in Hospitalized Patients with COVID-19 Pneumonia (Enrolling by Invitation Only) Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL

    The primary objective of this study is to assess whether the use of lenzilumab in addition to current standard of care (SOC) can alleviate the immune-mediated cytokine release syndrome (CRS) and prevent progression to respiratory failure and/or death in high risk patients with COVID-19 pneumonia.

  • A Study to Evaluate Acalabrutinib with Best Supportive Care in Participants Hospitalized with COVID-19 (Enrolling by Invitation Only) Rochester, MN

    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.

  • A Study to Evaluate Convalescent Plasma to Stem Coronavirus Scottsdale/Phoenix, AZ


    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.

  • A Study to Evaluate Filter Comparison for Reducing COVID-19 Infection Risk Rochester, MN

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

  • A Study to Compare BAL CD8+ TRM Cells and Lung Fibrosis Scores in COVID-19 Infection Survivors Rochester, MN

    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.

     

  • A Study to Evaluate the Feasibility of Rapid COVID-19 Testing in Disadvantaged Populations Rochester, MN

    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 ...

  • ADORE: impAct of coviD On feRtility carE Rochester, MN

    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.

     

  • Health Coaching Post COVID Rochester, MN

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

  • Patients Perceptions of Long-Haul COVID-19 Rochester, MN

    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.

  • Mindfulness Intervention for Post-Covid Symptoms Rochester, MN

    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.

  • A Study to Establish a Registry of Post-COVID Investigations, Education and Symptom Management Rochester, MN

    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. 

  • Research to Test Whether Doing Exercise Training Helps Lessen or Prevent the Longer-term Symptoms of COVID-19 Infection Jacksonville, FL

    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.

     

     

  • Evaluation of the Efficacy and Safety of Sarilumab in Hospitalized Patients With COVID-19 (enrollment by invitation only) Rochester, MN

    Phase 2: The primary objective of the study is to evaluate the clinical efficacy of sarilumab relative to the control arm in adult patients hospitalized with severe COVID-19.

    Phase 3: The primary objective of the study is to evaluate the clinical efficacy of sarilumab relative to the control arm in adult patients hospitalized with severe or critical COVID-19.

  • MAGPIES Biorepository Rochester, MN

    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 ...

  • Alpha-1 Antitrypsin Mutation in COVID Positive Patients Who Are Hospitalized Jacksonville, FL

    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.

  • Phase III DAS181 Lower Tract PIV Infection in Immunocompromised Subjects (Substudy: DAS181 for COVID-19): RCT Study Rochester, MN

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

  • A Study to Evaluate the Safety and Efficacy of Tocilizumab in Patients With Severe COVID-19 Pneumonia (enrollment by invitation only) Rochester, MN

    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.

  • Efficacy and Safety of COVID-19 Vaccine in Cancer Patients Jacksonville, FL

    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.

  • A Study to Investigate Intravenous Tocilizumab in Patients with Moderate-to-Severe COVID-19 Pneumonia (enrolling by invitation only) Jacksonville, FL; Scottsdale/Phoenix, AZ

    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. 

  • A Study to Evaluate Early Detection of SARS-CoV-2/COVID-19 in High Risk Radiation Oncology Patients Rochester, MN

    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.

     

  • A Study to Analyze Potential Long-term Treatments for Covid-19 Recovery Scottsdale/Phoenix, AZ

    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.

     

  • A Study to Determine the Effects of COVID-19 in Cancer Patients Scottsdale/Phoenix, AZ; Mankato, MN; La Crosse, WI; Eau Claire, WI; Rochester, MN

    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.

  • Treatment burden, stress, and coping in the context of social distancing: A qualitative study of patients with diabetes mellitus Rochester, MN

    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 ...

  • A Study to Assess Steroid Dosing by bioMARker Guided Titration in Critically Ill Patients With Pneumonia Rochester, MN

    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.

  • Safety and Immune Response of the COVID 19 Vaccine in Patients with Inflammatory Bowel Disease Jacksonville, FL

    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.

  • A Study to Evaluate Impact of COVID-19 on Inflammatory Bowel Disease Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN

    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.

     

  • Tele-Medicine in an Advanced Prostate Cancer Clinic Rochester, MN

    The purpose of this study is to describe the use of tele-medicine during the COVID-19 pandemic in our advance prostate cancer practice and evaluate patient satisfaction.

  • A Study to Evaluate Rivaroxaban to Reduce Risk of Major Venous and Arterial Thrombotic Events, Hospitalization and Death in Medically Ill Outpatients with Acute COVID-19 Infection Rochester, MN

    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.

  • COVID-19 (Coronavirus) Pandemic on Health and Healthcare Rochester, MN

    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.

  • A Study to Determine Late Outcomes and Immunological Responses in Children With/Without Multisystem Inflammatory Syndrome After SARS-CoV-2 Rochester, MN

    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. 

  • A Study to Evaluate Positive SARS-CoV-2 Antibodies in Subjects with Bipolar Disorder Rochester, MN

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

  • COVID-19 and Acute Renal Failure Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL

    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).

     

     

     

  • Screening for Sleep Disordered Breathing and Sleep Disturbance Among Patients Recovered from COVID Infection Jacksonville, FL

    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. 

  • Continuous Glucose Monitor (CGM) Use in COVID-19 Patients Jacksonville, FL

    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.

     

  • A Study to Evaluate MesilatE for Treating Hospitalized Patients with COVID-19 (Enrolling by Invitation Only) Jacksonville, FL

    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.

     

     

  • COVFIS-HOME: COVID-19 Pilot Study of Fisetin to Alleviate Dysfunction and Decrease Complications Rochester, MN

    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.

  • Immunological Consequences of COVID-19 Vaccination in Patients with Rheumatic Diseases Rochester, MN

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

  • A Study to Evaluate At Home Administration of Pertuzumab Combined with Trastuzumab to Treat Patients with HER2-Positive Breast Cancer During COVID-19 Pandemic Jacksonville, FL; Rochester, MN

    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.

  • Voice Signal PASC Study Rochester, MN

    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

  • Immunogenicity and Safety of Vaccines Against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in Patients with Hematologic Malignancies and Associated Precursors Rochester, MN

    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.

  • A Study to Evaluate the Effectiveness and Safety of Remdesivir to Treat Coronavirus Disease 2019 in an Outpatient Setting Rochester, MN

    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.

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