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Here are the studies that match your search criteria. If you are interested in participating, please reach out to the contact listed for the study. If no contact is listed, contact us and we'll help you find the right person.

612 Study Matches

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Rapid Throughput Screening for Human COVID-19 Infection: A ECG study (RACE)

A Study to Evaluate Rapid Throughput Screening for Human COVID-19 Infection

Elie Berbari
All
18 years and over
This study is NOT accepting healthy volunteers
2020-302666-H01-RST
20-011415
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Inclusion Criteria:

  • Adult males and females age 18 or greater.
  • Undergoing COVID-19 testing by PCR.
  • Willing and able to provide informed consent.
  • Pregnant females (minimal risk study, no risk from ECG).


Exclusion Criteria:

  • Unwilling or unable to provide informed consent.
Coronavirus disease 2019, General infectious diseases
COVID-19, COVID-19 diagnostic testing, Disease caused by 2019 novel coronavirus, Disease caused by 2019-nCoV, Respiratory system
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Mayo Clinic — Rochester, MN

Pilot Studies to Reduce COVID19 Infection Risk During Clinical Cardiopulmonary Exercise Testing

A Study to Evaluate Filter Comparison for Reducing COVID-19 Infection Risk

Bruce Johnson
All
18 years to 65 years old
Not Applicable
This study is NOT accepting healthy volunteers
2020-300566-H01-RST
20-004751
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Inclusion Criteria:

  • Healthy participants between the age 18-65 years old.
  • Capable of performing submaximal exercise without any known history of heart disease or any past history that would prevent them from performing the exercise and procedures in the study.
  • Women of child bearing age will be required to take a urine pregnancy test.
  • Participants will have to fill out a medical questionnaire.


Exclusion Criteria:

  • Participants less than the age of 18 years.
  • Participants more than the age of 65 years.
  • Participants with compromised cardiovascular or pulmonary function.
  • Unable to pedal an exercise ergometer.
  • Pregnant women as there would be no direct benefit and we do not want to cause undue harm.
Cardiopulmonary exercise test, Other
Coronavirus disease 2019, General infectious diseases
At increased risk of exposure to Severe acute respiratory syndrome coronavirus 2, COVID-19, CPET, Disease caused by 2019 novel coronavirus, Disease caused by 2019-nCoV, Respiratory system
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Mayo Clinic — Rochester, MN

Integrated Biomarker Panel for COVID-19 Infection Risk and Severity Prediction

A Study to Establish An Integrated Biomarker Panel for COVID-19 Infection Risk and Severity Prediction

Alicia Algeciras-Schimnich
All
18 years and over
This study is NOT accepting healthy volunteers
2021-303792-H01-RST
21-001923
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Inclusion Criteria:

  • Age ≥ 18 years.​​​​​​​
  • Mayo Clinic patients that have had exposure to SARS-CoV2 virus and/or symptoms related to COVID-19 infection and present to Mayo Clinic for testing.
  • Patients that are willing to consent for a blood draw and provide a blood sample.


Exclusion Criteria:
 

  • Individuals < 18 years  of age.
  • Patients on active treatment for cancer and/or those on immunosuppressants.
  • Pregnant and breast-feeding women.
  • Patients who have had COVID-19 in the past, confirmed in the medical record.
  • Patients who are unable to give written/verbal consent or are unwilling to participate.
Coronavirus disease 2019, General infectious diseases
At risk for infection, COVID-19, COVID-19 diagnostic testing, Disease caused by 2019 novel coronavirus, Disease caused by 2019-nCoV, Disorder due to infection, Exposure to 2019 novel coronavirus, Exposure to SARS-CoV-2, Respiratory system
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Mayo Clinic — Rochester, MN

A Prospective Observational Study to Correlate BAL CD8+ TRM Cells and Quantitative Lung Fibrosis Scores in Survivors of Moderate-to-Severe COVID-19 Infection (COVID-19 BAL)

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

Robert Vassallo
All
60 years to 85 years old
This study is NOT accepting healthy volunteers
2020-300641-H01-RST
20-004911
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Inclusion Criteria
•COVID-19 Cohort:

  • Patient age: 60-85 years old.
  • SARS-CoV-2 infection confirmed by PCR.
  • Need for hospitalization due to COVID-19 pneumonia.
  • Need for ≥ 2L supplemental oxygen at any point during hospitalization.

Inclusion Criteria
•CONTROL Cohort
:

  • Patient age: 60-85 years old.
  • No pre-existing history of interstitial lung disease or chronic lung disease, except for mild COPD with FEV1 > 80% predicted and FEV1/FVC < 0.7.
  • Absence of lung infiltrate, fever or any signs or infection.
  • Undergoing bronchoscopy for evaluation of lung nodule or adenopathy.

Exclusion Criteria
•COVID-19 and CONTROL Cohorts
:

  • Unable to provide consent to participate in the study.
  • Patient under guardianship or curatorship.
  • Pre-existing interstitial lung disease, pulmonary fibrosis or chronic lung disease, except for mild COPD as outlined in “inclusion criteria.”
  • Active cigarette smoking, vaping or other inhalation use (former smoker providing quit > 90 days prior to admission acceptable).
  • > 20 pack years.
  • Immunocompromised host status due to ongoing therapy with methotrexate, cellcept, azathioprine, prednisone dose > 15 mg daily, rituximab, cyclophosphamide or other biologic agents.
  • Chemotherapy or Radiation therapy in last 2 years.
Coronavirus disease 2019, General infectious diseases
COVID-19, Disease caused by 2019 novel coronavirus, Disease caused by 2019-nCoV, Fibrosis of lung, Patient requires hospitalization, Pneumonia caused by SARS-CoV-2, Respiratory system
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Mayo Clinic — Rochester, MN

Generation of Algorithms that Enable Early Detection of Symptomatic SARS-CoV-2/COVID-19 Infection in High Risk Employees

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

Jordan Miller
All
18 years and over
This study is NOT accepting healthy volunteers
2020-102384-P01-RST
20-003412
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Inclusion Criteria:

  • Age 18 years or older.
  • Employed at > 0.75 FTE as a healthcare worker, emergency services worker, or critical services employee that has direct contact with patients/customers and cannot abide by social distancing guidelines.
    • Physicians, nurses, allied health, etc.;
    • Police officers, State Patrol, etc.;
    • Cashiers, other positions that can clearly describe how the above criteria place them at high-risk due to regular interactions.
  • Patient is comfortable and willing to interact with a tablet-based interface on a daily basis.


Exclusion Criteria:

  • Under the age of 18 years old.
  • Has previously tested positive or has a pending test for SARS-CoV-2/COVID-19.
  • Is currently undergoing self-quarantine for suspected COVID-19.
  • Works less than 0.75 FTE or cannot clearly articulate the nature of patient/interpersonal interactions that place them at high-risk.
  • Is unable to read and/or unwilling to interact with a tablet-based interface for daily questionnaire.
  • Is unwilling or unable to provide baseline data required for entry into the study.
  • Recent history of unexpected hospitalizations due to a chronic medical condition (e.g., chronic, unstable heart failure).
  • Travel to and from a high-risk area within the past 14 days (e.g., U.S. or international “hot spot”).
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Mayo Clinic Rochester, MN — Rochester, MN

Generation of Algorithms for Early Prediction of Aggressive Progression and Hospitalization in Patients Diagnosed with SARS-CoV-2/COVID-19 Infection

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

Jordan Miller
All
18 years and over
Post Market
This study is NOT accepting healthy volunteers
2020-102394-P01-RST
20-003477
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Inclusion Criteria:

  • Over the age of 18 years old.
  • Received a positive test for COVID-19 within the past 48 hours and can provide documentation of the test.
  • Self reports that the patient is comfortable and willing to interact with a tablet-based interface on a daily basis.


Exclusion Criteria:

  • Under the age of 18 years old.
  • Tested positive more than 48 hours prior to contacting study staff or has a pending test for SARS-CoV-2/COVID-19.
  • Cannot confirm a positive test for COVID-19. 
  • Unable to read and/or unwilling to interact with a tablet-based interface for daily questionnaire.
  • Unwilling or unable to provide baseline data required for entry into the study.
  • Currently enrolled in a remote monitoring program via the Center for Connected Care.
  • Any of the following conditions that are contraindicated for use with this device:
    • pacemaker implantation;
    • implantable defibrillator;
    • use of a neuro-stimulator.
Device, Health technology assessment procedure, Research data collection
Coronavirus disease 2019
COVID-19, Disease caused by 2019 novel coronavirus, Disease caused by 2019-nCoV, Respiratory system
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A Multicenter, Randomized, Placebo-controlled, Pragmatic Phase 3 Study Investigating the Efficacy and Safety of Rivaroxaban to Reduce the Risk of Major Venous and Arterial Thrombotic Events, Hospitalization and Death in Medically Ill Outpatients with Acute, Symptomatic COVID-19 Infection (PREVENT-HD)

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

Paul Daniels
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
2021-303843-P01-RST
21-001915
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Inclusion Criteria:
 

  • Male or female (according to their reproductive organs and functions assigned by chromosomal complement).
  • 18 years of age or older.
  • COVID-19 positive diagnosis by locally obtained viral diagnostic test (e.g., PCR). This may be nasal swab or saliva test or other available technology to demonstrate current infection.
    • Note: this is not an antibody test or serology test that just indicate prior exposure to the disease. In the case of multiple positive COVID-19 PCR tests, only the date of the first test may be used.
  • Confirm that participant is known to health system, with at least 1 contact in EMR prior to screening.
  • Symptoms attributable to COVID-19.
  • Initial treatment plan does not include hospitalization.
  • Presence of at least 1 additional risk factor:
    • Age ≥ 60 years;
    • Prior history of VTE;
    • History of thrombophilia;
    • History of CAD;
    • History of PAD;
    • History of cerebrovascular disease or ischemic stroke;
    • History of cancer (other than basal cell carcinoma);
    • History of diabetes requiring medication;
    • History of heart failure;
    • Body Mass Index ≥ 35 kg/m^2;
    • D-dimer > upper limit of normal for local laboratory (within 2 weeks of the date of the COVID-19 test and prior to randomization).
  • Must provide consent via eConsent indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study, including follow up.
  • Willing and able to adhere to the lifestyle restrictions specified in this protocol.


Exclusion Criteria:

  • Increased risk of bleeding such as:
    • significant bleeding in the last 3 months;
    • active gastroduodenal ulcer in the last 3 months;
    • history of bronchiectasis or pulmonary cavitation;
    • need for dual antiplatelet therapy or anticoagulation;
    • prior intracranial hemorrhage;
    • known severe thrombocytopenia (platelet count <50 x 10^9/L); or
    • active cancer and undergoing treatment.
  • Any illness or condition that in the opinion of the investigator would significantly increase the risk of bleeding (eg recent trauma, recent surgery, severe uncontrolledhypertension, gastrointestinal cancer, renal failure requiring dialysis, severe liver disease, known bleeding diathesis)
  • Known allergies, hypersensitivity, or intolerance to rivaroxaban or its excipients (refer to the IB).
  • Positive COVID-19 antibody or serology test after 2-week period of acute, symptomatic COVID-19 infection.
  • Known diagnosis of triple positive (i.e., positive for lupus anticoagulant, anticardiolipin, and anti-beta 2-glycoprotein I antibodies) antiphospholipid syndrome.
  • Recently taken or required to take any disallowed therapies.
  • Concomitant Therapy before the planned first dose of study intervention or required during the study. For example, the need for the use of strong cytochrome P450 (CYP) 3A4 inhibitor or inducer per local prescribing information.
  • Received an investigational intervention (including investigational vaccines) or used an invasive investigational medical device within 30 days before the planned first dose of study intervention or is currently enrolled in an experimental, investigational study.
    • Note: participation in an observational registry is allowed.
  • Women who are pregnant or breastfeeding and women of childbearing potential without proper contraceptive measures.
Drug, Other
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Mayo Clinic — Rochester, MN

Strategies and Treatments for Respiratory Infections &; Viral Emergencies (STRIVE): Shionogi Protease Inhibitor

All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT05605093
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Inclusion Criteria:

• Age ≥18 years.
• Informed consent for trial participation.
• Hospital admission (or boarding in an emergency department or other area awaiting hospital admission) with signs and/or symptoms of a respiratory infection.
• Confirmation of SARS-CoV2 infection by nucleic acid test (NAT) or equivalent non- NAT test [list of approved tests is in the PIM] collected within the prior 14 days.
• Onset of symptoms attributable to SARS-CoV2 infection occurred within 14 days before randomization.
• Hospitalized for the management of COVID-19, with signs and/or symptoms suggestive of lower respiratory tract infection.
Exclusion Criteria:

• The patient is expected to be discharged from the hospital within the next 24 hours.
• Medical condition other than the acute respiratory infection (and its manifestations) that is likely to result in death within 7 days of randomization.
• Use of a strong CYP3A inducer within 14 days prior to enrollment
• Moribund condition, defined as prior cardiac arrest during this hospitalization and life expectancy less than 48 hours of randomization.
• Patient undergoing comfort care measures only such that treatment focuses on end-of- life symptom management over prolongation of life.
• Expected inability or unwillingness to participate in study procedures.
• In the opinion of the investigator, participation in a trial is not in the best interest of the patient.
• Allergy to investigational agent or vehicle
• Use of a concomitant medication that is contraindicated due to a drug-drug interaction with S-217622
• Moderate to severe hepatic impairment (i.e., Child-Pugh class B or C) or acute liver failure.
• Known estimated glomerular filtration rate (eGRF) <30 mL/min/1.73m 2
• Continuous renal replacement therapy or chronic dialysis
• Current pregnancy
• Current breastfeeding and unwillingness to defer breastfeeding for 30 days after the last dose of investigational agent.
• Women of child-bearing potential who are unwilling to abstain from sexual intercourse with men or practice appropriate contraception through 30 days from the last dose of the investigational agent.
• Men who are unwilling to abstain from sexual intercourse with women of child- bearing potential or to use barrier contraception through 30 days from the last dose of the investigational agent.
• Inability to take investigational agent in tablet form by mouth.
Drug: Shionogi Protease Inhibitor (S-217622), Drug: placebo
COVID-19
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Location Contacts
Hennepin Healthcare Research Institute (Site 027-001) — Minneapolis, Minnesota Hennepin ICC
M Health Fairview University of Minnesota Medical Center (Site 112-001) — Minneapolis, Minnesota Hennepin ICC - (strivehenn@insight-trials.org)
University of Minnesota — Minneapolis, Minnesota Rebecca Schoenecker - (sitereg@insight-trials.org)

Strategies and Treatments for Respiratory Infections &Amp; Viral Emergencies (STRIVE): Immune Modulation Strategy Trial

All
18 Years and over
Phase 4
This study is NOT accepting healthy volunteers
NCT05822583
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Inclusion Criteria:

• Confirmation of SARS-CoV2 infection by nucleic acid test (NAT) or equivalent non-NAT test [list of approved tests in the PIM] within 14 days of randomization.
• Requiring hospitalization for the management of COVID-19
• Has evidence of COVID-19 pneumonia (PNA) defined as either receiving supplementary oxygen ≤2L of low flow oxygen with evidence of airspace disease on chest imaging (X ray, computer tomography or ultrasound) OR receiving supplementary oxygen >2L and <10 L of low flow oxygen.
• Currently receiving or planned to receive (ordered) one IM drug (for example, a corticosteroid or baricitinib) as part of treatment of COVID-19 prior to randomization.
• Has started supplemental oxygen for the treatment of COVID-19 within the past 5 calendar days. Patients on home oxygen are eligible if current oxygen flow rate is increased from baseline and other above criteria are met.
• Investigator agrees that the pneumonia is due to COVID-19.
Exclusion Criteria:

• Oxygen requirement of ≥10L or more of low flow oxygen (or equivalent if using Venturi mask, etc), or requiring either HFNO, NIV, IMV, or ECMO.
• Participant has received more than one baseline IM for treatment of the current COVID-19 infection at time of trial enrollment. (Examples: corticosteroid, baricitinib, tocilizumab, anakinra, abatacept, or infliximab.)
• Participant anticipated to not meet all inclusion criteria within 24 hours of randomization in the opinion of the investigator.
• Allergy to investigational agent.
• Neutropenia (absolute neutrophil count <1000 cells/μL) (<1.0 x 10 3 /μL or <1.0 G/L) on most recent lab within 2 calendar days of randomization.
• Lymphopenia (absolute lymphocyte count <200 cells/μL) (<0.20 x 10 3 /μL or <0.20 G/L) on most recent lab within 2 calendar days of randomization.
• Known or suspected active or recent serious infection (bacterial, fungal, viral, or parasitic infection, excepting SARS-CoV-2) that in the opinion of the investigator could constitute a risk when taking investigational agent. Note: Broad spectrum empiric antibiotic usage does not exclude participation.
• Known or suspected history of untreated tuberculosis (TB). TB diagnosis may be suspected based on medical history and concomitant therapies that would suggest TB infection. Participants are also excluded if they have known, latent TB treated for less than 4 weeks with appropriate anti-tuberculosis therapy per local guidelines (by history only, no screening required).
• Have received any live vaccine (or live attenuated) within 3 months before screening or intend to receive a live vaccine (or live attenuated) during the trial. Use of prior non-live (inactivated) vaccinations is allowed for all participants, including any vaccine for COVID-19.
• Pre-existing immunomodulation or immunosuppression that meets any of the following: Participant has received abatacept for an indication other than COVID- 19 within 5 half-lives (65 days) of enrollment (Abatacept elimination half-life is 13.1 days.) Participant is receiving immune modulatory therapy for autoimmune, transplant management or another indication AND has one or more of the following: evidence of active infection (other than COVID-19) or has required reduction in their immune modulatory therapy in the preceding 6 months due to infectious complication (routine reduction as SOC is not an exclusion) or has required intensification in immunotherapy within the preceding 6 months due to organ rejection/worsening underlying disease status (e.g., intensification with an additional agent on top of usual immunosuppressive regimen)
• Participant has recently received or is anticipated to require immune modulatory agents for their underlying disease including chemotherapeutic treatments likely to induce neutropenia (<1.0 x 10 9 cells/µL) or lymphopenia (<1.0 x 10 9 cells/µL)
• Participant has untreated advanced HIV (known CD4 <200 in the past 6 months) AND is not established on antiretroviral therapy
• Pregnancy
• Breastfeeding
• Co-enrollment in other trials not predetermined to be compatible with this trial.
• In the investigator's judgment, the patient has any advanced organ dysfunction that would not make participation appropriate.
• The treating clinician expects inability to participate in trial procedures or participation would not be in the best interests of the patient.
Drug: abatacept infusion, Drug: Placebo group
COVID-19
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University of Minnesota — Minneapolis, Minnesota Rebecca Schoenecker, MPH - (sitereg@insight-trials.org)

COVID-19 Cytokine Assay Validation (COVID-19)

COVID-19 Cytokine Assay

Alicia Algeciras-Schimnich
All
18 years to 60 years old
This study is NOT accepting healthy volunteers
2020-300235-H01-RST
20-004047
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Inclusion Critera:

  • Individuals ≥ 18 and ≤ 60 years of age
  • Has recently been clinically tested for COVID-19 qPCR with either known positive and symptomatic.
  • Patients must be within a radius of Rochester, MN, that allows for reasonable transportation time of the phlebotomist. 


Exclusion Criteria:

  • Patients without prior COVID-19 qPCR results, patients with ambiguous COVID-19 qPCR results.
  • Children under 18 years old or patients over 59 years old.
  • Pregnant women.
  • Patients over 60 years old. 
  • Patients residing beyond a 1 hour drive for the phlebotomist.

 

Coronavirus disease 2019, General infectious diseases
COVID-19, COVID-19 antibody testing, COVID-19 diagnostic testing, Disease caused by 2019 novel coronavirus, Disease caused by 2019-nCoV, Respiratory system
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Mayo Clinic — Rochester, MN

Mayo Clinic COVID-19 Pandemic Response Biobank (Prospective) (NA)

COVID-19 Biobank

Andrew Badley
All
Not specified
This study is NOT accepting healthy volunteers
2020-102184-H01-RST
20-003014
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Inclusion Criteria:

  • Cohort 1 Inclusion: 

  • Mayo Clinic patients known or suspected to be positive with COVID-19 and/or infection with SARS-CoV-2.
  • Hospitalized at time of identification.
  • All ages will be eligible with appropriate controls for pediatric patients.
  • All racial and ethnic groups are eligible. 
     
    Cohort 2 Inclusion:
  • Mayo Clinic patients known or suspected to be positive with COVID-19 and/or infection with SARS-CoV-2.
  • Not hospitalized at time of identification.
  • All racial and ethnic groups are eligible. 


Exclusion Criteria:

  • None.
Coronavirus disease 2019, General infectious diseases
COVID-19, Disease caused by 2019 novel coronavirus, Disease caused by 2019-nCoV, Respiratory system
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Mayo Clinic — Rochester, MN

Smartphone Enabled Home Screening for COVID-19 Using Electrocardiogram (ECG), Dried Blood Spot (DBS) and Mid-Turbinate NasAL Swab (SIGNAL)

Home Screening for COVID-19

Paul Friedman
All
18 years and over
This study is NOT accepting healthy volunteers
2021-303283-H01-RST
21-000149
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Inclusion Criteria:

  • ≥ 18 years of age.
  • Able to give informed consent; patients will be invited to consent via the portal.
  • Have a US mailing address.  


Exclusion Criteria:

  • Current or previous within 2 months infection to SARS-CoV-2.
  • No compatible smartphone to connect and run the AliveCor system (https://store.alivecor.com/products/kardiamobile).
Coronavirus disease 2019, General infectious diseases
COVID-19, COVID-19 diagnostic testing, Disease caused by 2019 novel coronavirus, Disease caused by 2019-nCoV, Respiratory system
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Mayo Clinic — Rochester, MN

Mayo Clinic COVID-19 Virtual Clinic: Post COVID-19 Survey

A Study to Evaluate Post COVID-19 Patients

Ravindra Ganesh
All
18 years and over
This study is NOT accepting healthy volunteers
2020-302902-H01-RST
20-012275
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Inclusion Criteria:
 

  • Mayo Clinic patients with positive COVID-19 test who agreed to follow up through video visit by Mayo COVID-19 Virtual Clinic providers.


Exclusion Criteria:
 

  • Non Mayo Clinic patients.
  • Patients with negative COVID-19 result
Coronavirus disease 2019, General infectious diseases
COVID-19, Chronic post-COVID-19 syndrome, Disease caused by 2019 novel coronavirus, Disease caused by 2019-nCoV, Post-acute COVID-19, Respiratory system
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Mayo Clinic — Rochester, MN

COVID-19 and Acute Kidney Injury (AKI) (COVAKI)

COVID-19 and Acute Renal Failure

Kai Singbartl
All
18 years and over
This study is NOT accepting healthy volunteers
2020-102344-H01-RST
20-003349
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Inclusion Criteria:
 

  • Adult patients, ≥ 18 years of age.
  • Patients testing positive for SARS-CoV-2 and requiring hospitalization at the Mayo Clinic Arizona, Rochester, or Florida campuses.


Exclusion Criteria:

  • Patients < 18 years of age.
  • Patients with pre-existing end-stage renal disease; i.e., need for renal replacement therapy (RRT) prior to index hospitalization.
Acute kidney failure, Acute kidney injury , Coronavirus disease 2019, General infectious diseases
Acute kidney injury due to disease caused by Severe acute respiratory syndrome coronavirus 2, Acute renal failure syndrome, COVID-19, Disease caused by 2019 novel coronavirus, Disease caused by 2019-nCoV, Patient requires hospitalization, Respiratory system, Urinary system
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Mayo Clinic — Rochester, MN

Perceptions of Patients who Have Navigated Long-Haul COVID-19

Patients Perceptions of Long-Haul COVID-19

LuAnn Fowler
All
18 years and over
This study is NOT accepting healthy volunteers
2022-308200-H01-RST
22-005063
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Inclusion Criteria:

  • ≥ 18 years of age and older.
  • Previous laboratory confirmed positive COVID-19 test.
  • Patient of the Public Health, Occupational Medicine, and Infectious Disease Clinic.
  • Patient of the Nurse Practitioner.


Exclusion Criteria:

  • Patients < 18 years of age.
  • Patients who are unable to return to work without restrictions and those who have not to return to work.
  • Patients who are not currently employed.

Eligibility last updated 6/23/22. Questions regarding updates should be directed to the study team contact.

 

 

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Mayo Clinic — Rochester, MN

Mayo Clinic COVID-19 Pandemic Response Biobank of Clinical Residual Samples

COVID-19 Residual Biobank (Enrolling by Invitation Only)

Robin Patel
All
Not specified
This study is NOT accepting healthy volunteers
2020-102269-H01-RST
20-003022
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Inclusion Criteria:

  • Mayo Clinic patients diagnosed with or suspected to have COVID-19 (infection with SARS-CoV-2).


Exclusion Criteria:

  • None.
Coronavirus disease 2019, General infectious diseases
COVID-19, COVID-19 antibody testing, COVID-19 diagnostic testing, Disease caused by 2019 novel coronavirus, Disease caused by 2019-nCoV, Respiratory system
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Mayo Clinic — Rochester, MN

ASPIRE II: Acknowledging Disparities In Pregnancy Care During COVID-19 (ASPIRE II)

Acknowledging diSParities In pRegnancy carE during COVID-19

Megan Allyse
Female
18 years and over
This study is NOT accepting healthy volunteers
2020-300469-H01-RST
20-004565
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Inclusion Criteria:

  • Female, age 18 or older.
  • Currently pregnant or pregnant within the past 12 months.
  • English or Spanish speaker.


Exclusion Criteria:
 

  • Under the age of 18.
  • Not currently pregnant or pregnant within the past 12 months.
  • Does not speak English or Spanish.
Coronavirus disease 2019, General infectious diseases
Antenatal care status, COVID-19, Disease caused by 2019 novel coronavirus, Disease caused by 2019-nCoV, Infection control, Reproductive system, Respiratory system
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Mayo Clinic — Rochester, MN

Tracking the Recovery of Respiratory Physiology in COVID-19 Patients a Pilot Study (RCR)

Recovery of Respiratory System in COVID-19 Patients

Bruce Johnson
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2021-303578-H01-RST
21-001028
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Inclusion Criteria:

  • Have a documented positive qRT-PCR for SARS-CoV-2 confirming prior COVID-19 diagnosis within the last 2-3 months.
  • At least 18 years of age.
  • Female subjects must not be pregnant or trying to become pregnant during the duration of study participation.
  • No known plans to move out of the state, or become unable to return to one of the Mayo Clinic sites for follow-up testing.
  • Must be able to provide clear informed written consent.


Exclusion Criteria:

  • Individuals with pacemakers or other implantable devices that will make interpreting a CT scan challenging.
  • Individuals with major limitations to exercise.
Behavioral
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Mayo Clinic — Rochester, MN

Cellular Senescence and Its Contribution to COVID-19 Long-Hauler Syndrome

Cellular Senescence and COVID-19 Long-Hauler Syndrome

James Kirkland
All
18 years and over
This study is NOT accepting healthy volunteers
2020-302785-H01-RST
20-011877
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Inclusion Criteria - Longhaulers Cohort:

Subject population: 100 men and women who have been diagnosed with Post-COVID syndrome.

  • Ability to give informed consent or LAR.
  • At least 18 years old.
  • Ability of subject or LAR to read and speak the English language.
  • Positive PCR or antibody test within 18 months of initial study visit.
  • Patient of the Long-Hauler Syndrome clinic and differential diagnosis of Long-Hauler Syndrome.


Exclusion Criteria:

  • Any potential participant who refuses medical record review.
  • Pregnant females.
  • Incarcerated individuals.
  • Inability to cooperate or any medical condition that, in the opinion of the investigator, interferes with the evaluation of the study objectives or increases the subject’s risk by participating in the study.
  • Patient is unfit to participate at the discretion of the Principal Investigator.

Inclusion Criteria - Control Cohort:

Subject population: 50 men and women who have not had a known case of COVID or Longhauler’s syndrome.

  • Ability to give informed consent or LAR.
  • At least 18 years old.
  • Ability of subject or LAR to read and speak the English language.


Exclusion Criteria:

  • Known case of COVID-19.
  • Any potential participant who refuses medical record review.
  • Pregnant females.
  • Incarcerated individuals.
  • Inability to cooperate or any medical condition that, in the opinion of the investigator, interferes with the evaluation of the study objectives or increases the subject’s risk by participating in the study.
  • Patient is unfit to participate at the discretion of the Principal Investigator.

Inclusion Criteria - COVID-19 Control Cohort:

Subject population: 50 men and women who have had a known case of COVID, but not Longhauler’s syndrome.

  • Ability to give informed consent or LAR.
  • At least 18 years old.
  • Ability of subject to read and speak the English language.
  • Known case of COVID-19.


Exclusion Criteria:

  • Known Longhauler’s syndrome/Post-COVID
  • Any potential participant who refuses medical record review.
  • Pregnant females.
  • Incarcerated individuals.
  • Inability to cooperate or any medical condition that, in the opinion of the investigator, interferes with the evaluation of the study objectives or increases the subject’s risk by participating in the study.

Eligibility last updated 11/19/21. Questions regarding updates should be directed to the study team contact.

Coronavirus disease 2019, General infectious diseases
COVID-19, Disease caused by 2019 novel coronavirus, Post-acute COVID-19, Respiratory system
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Mayo Clinic — Rochester, MN

Uncover mechanisms underlying the development of chronic lung sequelae post COVID-19

Uncovering Mechanisms Post COVID-19 Chronic Lung Sequelae

Robert Vassallo
All
18 years and over
This study is NOT accepting healthy volunteers
2023-310931-H01-RST
23-001888
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Inclusion Criteria:

Sequelae Group

  • Age ≥18 years at screening, PCR confirmed COVID19 illness (+PCR defines day 0 of illness), hospitalization for COVID-19, absence of pre-existing history of interstitial lung disease, or significant other lung disease.
  • Severity of illness will be categorized as moderate disease (supplemental oxygen need 1-8L at any time during hospitalization), severe disease (need for high flow oxygen delivery ≥ 8L at any time during hospitalization) and critical illness (need for ICU admission or mechanical ventilation).

Control Recovery Group

  • Age ≥ 18 years at screening.
  • PCR confirmed COVID-19 cases who had nonsymptomatic or mild acute infection that do not require hospitalization.
  • Absence of pre-existing history of interstitial lung disease, or significant other lung disease, absence of any ongoing respiratory and systemic symptoms.


Exclusion Criteria:
 

  • Inability to provide informed consent, evidence of pre-existing interstitial lung disease or chronic lung disease.
  • Active cigarette smoking, vaping or other inhalation use.
  • Immunocompromised host status due to ongoing therapy with methotrexate CellCept, azathioprine, rituximab, cyclophosphamide or other biologic agents.
  • > 20 pack year smoking history.
  • history of chemotherapy or radiation therapy in the last two years; and pregnancy.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 2/20/23. Questions regarding updates should be directed to the study team contact.

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Mayo Clinic — Rochester, MN

Human Genomic RNA Phage Display Libraries as a Screening Tool for Identification of COVID-19 Immune Serum Reactive Proteins: means of identifying potential vaccine targets and assays for serologic testing of anti-COVID immunity (COVID19PhageDisplay)

Development of Potential COVID-19 Vaccine and Serological Assay

Svetomir Markovic
All
18 years and over
This study is NOT accepting healthy volunteers
2020-102301-H01-RST
20-003378
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Inclusion Criteria
•COVID Patient:

  • Adults, age ≥ 18 years old.
  • Confirmed history of COVID-19 viral infection.
  • Now clinically recovered.
  • COVID-19 negative on re-testing or if COVID test is not available, must be symptom-free for 2 weeks.

Exclusion Criteria
•COVID Patient:

  • Post-recovery COVID-19 virus testing remains positive.

Inclusion Criteria 
•Healthy Volunteer:

  • Otherwise healthy adults (age ≥ 18).
  • Not acutely ill.

 

Coronavirus disease 2019, General infectious diseases
COVID-19, COVID-19 antibody testing, Disease caused by 2019 novel coronavirus, Disease caused by 2019-nCoV, Respiratory system
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Mayo Clinic — Rochester, MN

Mayo Clinic COVID-19 Pandemic Response Stool Biobank (Prospective)

Mayo Clinic COVID-19 Pandemic Response Stool Biobank (Prospective)

Konstantinos Lazaridis
All
18 years and over
This study is NOT accepting healthy volunteers
2020-301022-H01-RST
20-005988
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Inclusion Criteria:

  • Mayo Clinic patients with suspected COVID-19 including those who test positive or negative for SARS-CoV-2.
  • All patients 18 years of age and older will be eligible.
  • All racial and ethnic groups are eligible. 


Exclusion Criteria:

  • Individuals under 18 years of age.
Coronavirus disease 2019, General infectious diseases
COVID-19, Disease caused by 2019 novel coronavirus, Disease caused by 2019-nCoV, Respiratory system
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Mayo Clinic — Rochester, MN

Teleworking in the Health Care Industry Due to COVID-19: Employee Satisfaction and Implications

Teleworking in the Health Care Industry Due to COVID-19

Elizabeth Meiners
All
18 years and over
This study is NOT accepting healthy volunteers
2021-306410-H01-RST
21-011499
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Inclusion Criteria:

  • Current employees at Mayo Clinic who were transitioned from an in-person work environment to telework due to COVID-19 public health guidelines.


Exclusion Criteria:

  • Employees at Mayo Clinic who were not transitioned from an in-person work environment to telework due to COVID-19 public health guidelines.

Eligibility last updated 11/5/21. Questions regarding updates should be directed to the study team contact.

Coronavirus disease 2019, General infectious diseases
COVID-19, Disease caused by 2019 novel coronavirus, Respiratory system, Teleworker, Works at home
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Mayo Clinic — Rochester, MN

Dried Blood Spot (DBS) Testing to Assess Post COVID-19 Vaccination Antibody Response (DBS)

Dried Blood Spot COVID-19 Vaccination Response (Enrolling by Invitation Only)

Elitza Theel
All
18 years and over
This study is NOT accepting healthy volunteers
2021-303270-H01-RST
21-000098
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Inclusion Criteria:

  • Adults ≥ 18 years old.
  • DLMP employees who work on-site at SDSC.
  • Plan to complete the two dose SARS-CoV-2 vaccination schedule.


Exclusion Criteria:

  • Children < 18 years old.
  • Subjects who have previously been diagnosed with SARS-CoV-2 infection.
  • Subjects who test SARS-CoV-2 antibody positive on the pre-vaccination sample indicating prior infection.

 

Coronavirus disease 2019, General infectious diseases
COVID-19, COVID-19 antibody testing, Disease caused by 2019 novel coronavirus, Disease caused by 2019-nCoV, Respiratory system
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Mayo Clinic — Rochester, MN

Immunological consequences of COVID-19 vaccination in patients with Rheumatic Diseases

Immunological Consequences of COVID-19 Vaccination in Patients with Rheumatic Diseases

Hu Zeng
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2021-303399-H01-RST
21-000501
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Inclusion Criteria:

  • Rheumatologist confirmed diagnosis of one of the following diagnoses:
    • Systemic lupus erythematosus;
    • Sjogren syndrome;
    • Inflammatory myositis;
    • Psoriatic arthritis;
    • Osteoarthritis;
    • Gout;
    • Ankylosing spondylitis;
    • IBD-related arthritis.


Exclusion Criteria:
 

  • Active infection or untreated malignancy (other than skin cancer) at enrollment.
  • Pregnancy.
Administration of SARS-CoV-2 antigen vaccine, Other, 2019-nCoV vaccination
Arthritis, Coronavirus disease 2019, General infectious diseases, Lupus, Myositis, Osteoarthritis, Psoriatic arthritis, Sjogren's syndrome
COVID-19, Disease caused by 2019 novel coronavirus, Disease caused by 2019-nCoV, Idiopathic inflammatory myopathy, Musculoskeletal system, Osteoarthritis, Psoriatic arthritis, Respiratory system, Sjögren's syndrome, Systemic lupus erythematosus
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Mayo Clinic — Rochester, MN

NCI COVID-19 in Cancer Patients Study (N-CCaPS): A Longitudinal Natural History Study (NCICOVID)

A Study to Determine the Effects of COVID-19 in Cancer Patients

Mohammad Ranginwala
All
Not specified
This study is NOT accepting healthy volunteers
2020-301371-P01-MAIJ
20-007210
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Inclusion Criteria:

Step 0 Eligibility Criteria

  • No age restriction.
  • Patient must have a prior or current cancer diagnosis (e.g., solid tumor or hematologic malignancy) that fits into any one of the following categories:
    • Patient is receiving active treatment (defined as current treatment or treatment within the past 6 weeks) or will begin receiving treatment within the next 2 weeks for any CNS or hematologic malignancy or metastatic (Stage IV) solid tumor. Eligible treatment types for hematologic malignancy or metastatic cancer are chemotherapy, immunotherapy, monoclonal antibody therapy (e.g., rituximab, trastuzumab, cetuximab), targeted therapy (e.g., BRAF/MEK inhibitor, EGF-R inhibitor), endocrine therapy, radiation therapy, or targeted radionuclide therapy; or
    • Patient is receiving treatment (defined as current treatment or treatment within the past 6 weeks) or will begin receiving treatment within the next 2 weeks for non-metastatic (Stage I-III) solid tumor. Eligible treatment types for nonmetastatic cancer patients are intravenous chemotherapy, immunotherapy, targeted therapy, radiation therapy, targeted radionuclide therapy, or monoclonal antibody therapy, except trastuzumab/pertuzumab if not accompanied by chemotherapy; or
    • Patient has received an allogenic stem cell transplant or CAR-T cell or other modified cellular therapy at any time; or
    • Patient is currently receiving treatment or prophylaxis for Graft vs. Host Disease.

Testing for SARS CoV-2

  • Patient must have a pending or known positive viral test result for SARS-CoV-2:
    • Patients with prior negative viral SARS-CoV-2 test(s) are eligible if they are being tested again;
    • Patients 18 years of age and older with prior positive viral SARS-CoV-2 test(s) more than 14 days prior to enrollment to Step 1 are not eligible.
    • Patient must be undergoing or have undergone testing for SARS CoV-2:
  • HIV-infected patients are eligible.
  • Patients with CNS metastases are eligible.
  • Co-enrollment on other clinical trials (for cancer or for COVID-19) is allowed.

Step 1 Eligibility Criteria

  • Patient must have a documented positive viral SARS-CoV-2 test:
    • For patients 18 years of age or older, the specimen collection for the positive test must have occurred no earlier than 14 days prior to enrollment to Step 1;
    • For patients under 18 years of age, the specimen collection for the positive test must have occurred after January 31, 2020.
    • The viral test can be either a nucleic acid (PCR) test or an antigen test. Serological or antibody tests are not allowed.
    • The test must have received Emergency Use Approval (EUA) from the FDA and be performed in a CLIA certified lab or patient care setting operating under a CLIA Certificate of Waiver. A full list of tests that have been approved under the EUA can be accessed at:

https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19- emergency-use-authorizations-medical-devices/vitro-diagnostics-euas.

  • Any specimen source (e.g., nasopharyngeal swab, oropharyngeal swab, etc.) is allowable for the viral SARS-CoV-2 test.

 

Brain metastasis, Brain tumor, Cancer, Coronavirus disease 2019, General infectious diseases, Graft versus host disease
Allogeneic stem cell transplant, Autologous stem cell transplant, Biological therapy for cancer, Bone marrow transplant, COVID-19, Cancer treatment, Chemotherapy, Disease caused by 2019 novel coronavirus, Disease caused by 2019-nCoV, Malignant neoplastic disease, Medical Oncology, Nervous system, Radiation therapy, Respiratory system, Targeted drug therapy
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Mayo Clinic Health System — Mankato, MN

NCI COVID-19 in Cancer Patients Study (N-CCaPS): A Longitudinal Natural History Study (NCICOVID)

A Study to Determine the Effects of COVID-19 in Cancer Patients

Carola Arndt
All
Not specified
This study is NOT accepting healthy volunteers
2020-301371-P01-RST
20-007210
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Inclusion Criteria:

Step 0 Eligibility Criteria

  • No age restriction.
  • Patient must have a prior or current cancer diagnosis (e.g., solid tumor or hematologic malignancy) that fits into any one of the following categories:
    • Patient is receiving active treatment (defined as current treatment or treatment within the past 6 weeks) or will begin receiving treatment within the next 2 weeks for any CNS or hematologic malignancy or metastatic (Stage IV) solid tumor. Eligible treatment types for hematologic malignancy or metastatic cancer are chemotherapy, immunotherapy, monoclonal antibody therapy (e.g., rituximab, trastuzumab, cetuximab), targeted therapy (e.g., BRAF/MEK inhibitor, EGF-R inhibitor), endocrine therapy, radiation therapy, or targeted radionuclide therapy; or
    • Patient is receiving treatment (defined as current treatment or treatment within the past 6 weeks) or will begin receiving treatment within the next 2 weeks for non-metastatic (Stage I-III) solid tumor. Eligible treatment types for nonmetastatic cancer patients are intravenous chemotherapy, immunotherapy, targeted therapy, radiation therapy, targeted radionuclide therapy, or monoclonal antibody therapy, except trastuzumab/pertuzumab if not accompanied by chemotherapy; or
    • Patient has received an allogenic stem cell transplant or CAR-T cell or other modified cellular therapy at any time; or
    • Patient is currently receiving treatment or prophylaxis for Graft vs. Host Disease.

Testing for SARS CoV-2

  • Patient must have a pending or known positive viral test result for SARS-CoV-2:
    • Patients with prior negative viral SARS-CoV-2 test(s) are eligible if they are being tested again;
    • Patients 18 years of age and older with prior positive viral SARS-CoV-2 test(s) more than 14 days prior to enrollment to Step 1 are not eligible.
    • Patient must be undergoing or have undergone testing for SARS CoV-2:
  • HIV-infected patients are eligible.
  • Patients with CNS metastases are eligible.
  • Co-enrollment on other clinical trials (for cancer or for COVID-19) is allowed.

Step 1 Eligibility Criteria

  • Patient must have a documented positive viral SARS-CoV-2 test:
    • For patients 18 years of age or older, the specimen collection for the positive test must have occurred no earlier than 14 days prior to enrollment to Step 1;
    • For patients under 18 years of age, the specimen collection for the positive test must have occurred after January 31, 2020.
    • The viral test can be either a nucleic acid (PCR) test or an antigen test. Serological or antibody tests are not allowed.
    • The test must have received Emergency Use Approval (EUA) from the FDA and be performed in a CLIA certified lab or patient care setting operating under a CLIA Certificate of Waiver. A full list of tests that have been approved under the EUA can be accessed at:

https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19- emergency-use-authorizations-medical-devices/vitro-diagnostics-euas.

  • Any specimen source (e.g., nasopharyngeal swab, oropharyngeal swab, etc.) is allowable for the viral SARS-CoV-2 test.

 

Brain metastasis, Brain tumor, Cancer, Coronavirus disease 2019, General infectious diseases, Graft versus host disease
Allogeneic stem cell transplant, Autologous stem cell transplant, Biological therapy for cancer, Bone marrow transplant, COVID-19, Cancer treatment, Chemotherapy, Disease caused by 2019 novel coronavirus, Disease caused by 2019-nCoV, Malignant neoplastic disease, Medical Oncology, Nervous system, Radiation therapy, Respiratory system, Targeted drug therapy
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Mayo Clinic — Rochester, MN

Survey Study to Evaluate Impact of the COVID-19 Pandemic on Inflammatory Bowel Disease at a Multisite Tertiary Institution (IBDCOV20)

A Study to Evaluate Impact of COVID-19 on Inflammatory Bowel Disease

Victor Chedid
All
18 years and over
This study is NOT accepting healthy volunteers
2020-302989-H01-RST
20-012188
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Inclusion Criteria:

  • Adult patients, ≥ 18 years of age.
  • Diagnosed with Inflammatory Bowel Disease (Crohn's or ulcerative colitis).


Exclusion Criteria:

  • Individuals < 18 years of age.

 

Coronavirus disease 2019, Crohn's disease, General infectious diseases, Inflammatory bowel disease, Ulcerative colitis
COVID-19, Crohn's disease, Digestive system, Disease caused by 2019 novel coronavirus, Disease caused by 2019-nCoV, Respiratory system, Ulcerative colitis
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Mayo Clinic — Rochester, MN

A Multicenter Platform Trial of Putative Therapeutics for the Treatment of COVID-19 in Hospitalized Adults (ACTIV-5 / BET)

ACTIV-5 / Big Effect Trial (BET-B) for the Treatment of COVID-19

Zelalem Temesgen
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2021-305266-P01-RST
21-007449
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Inclusion Criteria:

  • Admitted to a hospital with symptoms suggestive of Coronavirus Disease 2019 (COVID-19) and requires ongoing medical care.
  • Subject (or legally authorized representative) provides informed consent prior to initiation of any study procedures.
  • Subject (or legally authorized representative) understands and agrees to comply with planned study procedures.
  • Male or non-pregnant female adult ≥ 18 years of age at time of enrollment.
  • Illness of any duration and has laboratory-confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection as determined by polymerase chain reaction (PCR) or other commercial or public health assay (e.g., Nucleic Acid Amplification Test [NAAT], antigen test) in any respiratory specimen, or saliva 5 times the upper limit of normal.
  • Illness of any duration, and requiring, just prior to randomization, supplemental oxygen (any flow), mechanical ventilation or ECMO (ordinal scale category 5, 6, or 7). 
  • Women of childbearing potential must agree to either abstinence or use at least one acceptable method of contraception from time of screening through 5 months post study IP dosing.
    • Note: acceptable methods include barrier contraceptives (condoms or diaphragms) with spermicide, intrauterine devices (IUDs), hormonal contraceptives, oral contraceptive pills, and surgical sterilization. 
  • Agrees not to participate in another blinded clinical trial (both pharmacologic and other types of interventions) for the treatment of COVID-19 through day 29. 


Exclusion Criteria:

  • ALT or AST > 5 times the upper limit of normal. 
  • Subjects with a low glomerular filtration rate (eGFR), specifically:
    • Subjects with a glomerular filtration rate (eGFR) 20-30 mL/min are excluded unless in the opinion of the principal investigator (PI), the potential benefit of participation outweighs the potential risk of study participation;
    • All subjects with a glomerular filtration rate (eGFR) < 20 mL/min (including hemodialysis and hemofiltration) are excluded.
  • Pregnancy or breast feeding.
  • Anticipated discharge from the hospital or transfer to another hospital which is not a study site within 72 hours of enrollment.
  • Allergy to any study medication.
  • Received five or more doses of remdesivir prior to screening.
  • Received two or more doses of > 60 mg of prednisone or equivalent in the 7 days prior to screening.
  • Received small molecule tyrosine kinase inhibitors, including Janus kinase (JAK) inhibitors (e.g., baricitinib, ibrutinib, acalabrutinib, imatinib, gefitinib), in the 4 weeks prior to screening.
  • Received monoclonal antibodies targeting cytokines (e.g., tumor necrosis factor (TNF) inhibitors, anti-IL-1 [e.g., anakinra, canakinumab], anti-IL-6 [e.g., tocilizumab, sarilumab, sitlukimab]), or T-cells (e.g., abatacept) in the 4 weeks prior to screening.
  • Received monoclonal antibodies targeting B-cells (e.g., rituximab, and including any targeting multiple cell lines including B-cells) in the 3 months prior to screening.
  • Received granulocyte-macrophage colony-stimulating factor (GM-CSF) agents (e.g., sargramostim) within 2 months prior to screening.
  • Received other immunosuppressants in the 4 weeks prior to screening and in the judgement of the investigator, the risk of immunosuppression with lenzilumab is larger than the risk of Coronavirus Disease 2019 (COVID-19).
  • Received any live vaccine in the 4 weeks prior to screening.
  • Known active tuberculosis.
  • Known history of Human Immunodeficiency Virus (HIV), Hepatitis B (HBV) or untreated hepatitis C (HCV) infection.
  • History of pulmonary alveolar proteinosis (PAP).
  • Has a malignancy currently receiving immunosuppressive chemotherapy, immunodeficiency, uncontrolled opportunistic infection, or uncontrolled cirrhosis.
  • Has a medical condition that could, in the judgment of the investigator, limit the interpretation and generalizability of trial results.
  • Positive test for influenza virus during the current illness (influenza testing is not required by protocol).
  • Previous participation in an ACTIV-5/Big Effect Trial (BET).
Biologic/Vaccine, Drug, Other
Coronavirus disease 2019, General infectious diseases
COVID-19, Disease caused by 2019 novel coronavirus, Respiratory system
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Mayo Clinic — Rochester, MN

ROR2002: Generation of Algorithms that Enable Early Detection of SARS-CoV-2/COVID-19 Infection and Unrelated Mechanisms of Clinical Decline in High Risk Radiation Oncology Patient Populations (ROR2002)

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

Jordan Miller
All
18 years and over
This study is NOT accepting healthy volunteers
2020-102396-P01-RST
20-003478
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Inclusion Criteria:

  • Over the age of 18 years old.
  • Is currently undergoing clinically-indicated care in the Radiation Oncology Practice or scheduled to start treatment in the Radiation Oncology Practice at Mayo Clinic Rochester.
  • Self reports that the patient is comfortable and willing to interact with a tablet-based interface on a daily basis.
  • Remaining treatment duration of at least 2 weeks.


Exclusion Criteria:

  • Under the age of 18 years old.
  • Has previously tested positive or has a pending test for SARS-CoV-2/COVID-19.
  • Is currently undergoing self-quarantine for suspected COVID-19.
  • Is unable to read and/or unwilling to interact with a tablet-based interface for daily questionnaire.
  • Is unwilling or unable to provide baseline data required for entry into the study.
  • Recent history of unexpected hospitalizations due to a chronic medical condition (e.g., chronic, unstable heart failure).
  • Currently enrolled in the Remote monitoring program via Center for Connected Care.
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Mayo Clinic Rochester, MN — Rochester, MN