coronavirus disease 2019 (covid 19)

Displaying 44 studies

  • 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 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.

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

    This Research Repository will prospectively 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.  Participants will be approached for consent by the study team after the samples are identified. Samples and data from this repository will be made available to researchers with IRB-approved research projects after review and approval by the COVID-19 Access Committee.  We believe this biobank will enable high quality research to improve clinical practice and patient outcomes.

  • 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 ...

  • 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 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.

  • 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 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 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

    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 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 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.

     

  • 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.

  • 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 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.

  • 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

    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.

  • 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 ...

  • 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 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.

  • 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 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.

  • 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 Effectiveness and Safety of Ravulizumab vs. Best Supportive Care in Patients with COVID-19 Severe Pneumonia, Acute Lung Injury, or Acute Respiratory Distress Syndrome (Enrolling by Invitation Only) Jacksonville, FL; Rochester, MN; Mankato, MN; La Crosse, WI; Eau Claire, WI

    The purpose of this study is to evaluate the safety and effectiveness of Ravulizumab compared to Supportive Care in patients with COVID-19 severe pneumonia.

     

     

  • 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.

     

  • 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 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 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.

  • 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.

     

     

  • 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.

  • 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).

     

     

     

  • 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.

  • 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 ...

  • 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.  

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