Coronavirus disease 2019 (COVID-19)

Displaying 76 studies

  • COVID fellow education Rochester, MN

    Hand Surgery education has changed in recent months. Due to social distancing and closure of the anatomy lab, learning was moved to online modules. The hand surgery division is considering making these changes permanent. These were made available to hand surgery fellows outside of Mayo as well. We want to assess user’s satisfaction and perceived utility of the curriculum through a one-time online survey.

  • 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.

  • 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).

  • 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 Compare Saliva and Swab Specimens in Detection of COVID Severe Acute Respiratory Syndrome Albert Lea, MN; Austin, MN; Red Wing, MN; Owatonna, MN; Rochester, MN; Mankato, 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).

     

     

     

     

  • 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.

     

  • 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 ...

  • A Study to Compare Nasal Swabs to Detect Severe Acute Respiratory Syndrome Coronavirus 2 Albert Lea, MN; Austin, MN; Red Wing, MN; Owatonna, MN; Rochester, MN; Mankato, 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.

  • 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.

  • 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 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.

  • 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.

  • 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.

     

  • 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 ...

  • 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. 

  • 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. 

  • A Study to Evaluate the Cue COVID Rapid Test Albert Lea, MN; Austin, MN; Red Wing, MN; Owatonna, MN; Rochester, MN; Mankato, 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.

  • A Study to Evaluate Touchless Monitoring Device for COVID-19 Patients Rochester, MN

    1. The purpose of this pilot study is to determine if a touchless monitoring platform may provide respiratory and other clinical data on subjects with COVID-19. 

    Eventually, this type of data may assist in the care of COVID-19 patients, reduce provider time in the hospital room, and provide a platform to monitor patient recovery at home.

     

     

     

  • 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 Create a Registry of Individuals Who Have Not Had COVID-19, and are Interested in Possible Participation in COVID-19 Vaccine Clinical Trials Rochester, MN

    The study aims to create a registry of individiauls who have not had COVID-19 but are interested in participating in a COVID-19 vaccine trial. 

  • 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.

     

  • 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. 

  • 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.

  • 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 ...

  • 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 ...

  • 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.

  • 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 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.

  • Establishing An Integrated Biomarker Panel for COVID-19 Infection Risk and Severity Prediction Jacksonville, FL

    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 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 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. 

  • 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 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).

  • A Study to Evaluate 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 CPI-006 with Standard of Care vs. Placebo with Standard of Care in Mild-to-moderately Symptomatic Hospitalized Covid-19 Patients (Enrolling by Invitation Only) Jacksonville, FL; Rochester, MN

    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.

  • 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 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.

     

  • 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.

  • 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.

  • 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 ...

  • 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 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 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 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 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.

  • 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.

  • 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.

     

  • 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.

  • A Study to Evaluate the Safety and Effectiveness 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 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 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 SOLIRIS® to Treat Participants with Coronavirus Disease 2019 Rochester, MN

    Soliris, an effective and extensively studied terminal complement inhibitor with a well-established safety profile, is proposed as an emergency therapy for the treatment of participants who have a confirmed diagnosis of SARS-CoV-2 infection with a clinical presentation consistent with COVID-19 severe pneumonia, acute lung injury, or acute respiratory distress syndrome (ARDS). Soliris produces complete and sustained inhibition of C5-mediated terminal complement activity. It is hypothesized that treatment with Soliris could ameliorate COVID-19-induced lung injury, improve outcomes in participants with COVID-19 severe pneumonia, acute lung injury, or ARDS and, with supportive medical care, provide additional time for participants to recover.

  • 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.

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

  • 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 ...

  • Respiratory Virus Hospitalization Study (FLU 003 Plus) Rochester, MN

    Following the sudden and unexpected emergence of influenza A(H1N1)pdm09 (2009 H1N1) virus, this observational study was initiated to estimate rates of morbidity and mortality and to examine predictors of severity among participants with 2009 H1N1 infection. In 2011, as surveillance indicated that 2009 H1N1 virus was co-circulating with other seasonal influenza A and B viruses worldwide, the protocol was expanded to include other influenza A subtypes and influenza B viruses. The current version of the protocol (released in August 2013) further broadens the scope of this observational study. With the recognition that novel respiratory viruses other than novel influenza A ...

  • Use of Combined Prone Positioning and High-Flow Nasal Cannula, and Non-invasive Positive Pressure Ventilation to Prevent Intubation in COVID-19 Infection (enrolling by invitation only) Rochester, MN

    This research aims to understand if prone positioning combined with high-flow nasal cannula (HFNC) or non-invasive positive pressure ventilation (NIPPV) safely reduce the rate of intubation in acute hypoxemic and/or hypercapnic respiratory failure secondary to COVID-19 infection.

  • A Study to Evaluate Breathing Machine and Esophageal Pressures to Better Understand How COVID-19 Affects the Breathing and Lungs of Children (Enrolling by Invitation Only) Rochester, MN

    The purpose of this study is to gather information to help doctors understand how Covid-19 affects the lungs in children.  

  • 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).

     

     

     

  • 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). 

  • 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.

  • 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; Scottsdale/Phoenix, AZ

    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.

     

     

  • 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.

  • 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. 

  • 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.

.

Mayo Clinic Footer