• 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).

• Unwilling or unable to provide informed consent.

• 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.

• 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.

• 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.

• 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.

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.

• 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.

• 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”).

• 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.

• 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.

• 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.

• 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.

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. 

• 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.

• 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. 

• None.

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

• Non Mayo Clinic patients.
• Patients with negative COVID-19 result

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

• 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).

• 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.

• 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.

• ≥ 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.

• 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.

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

• None.

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

• Under the age of 18.
• Not currently pregnant or pregnant within the past 12 months.
• Does not speak English or Spanish.

• 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.

• Individuals with pacemakers or other implantable devices that will make interpreting a CT scan challenging.
• Individuals with major limitations to exercise.

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.

• 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.

• 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.

• 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.

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.

• 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.

• 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. 

• Individuals under 18 years of age.

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.

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

• 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.

• 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.

• Active infection or untreated malignancy (other than skin cancer) at enrollment.
• Pregnancy.

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

• 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.

• 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.

• 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.

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.

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.

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

• Individuals < 18 years of age.

• 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. 

• 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).

• 18 years of age or older at time of consent.
• Identified with one of 3 Post-Covid Syndrome (PASC) phenotypes at Mayo Clinic Rochester:  
  • fatigue-predominant  (N=20);
  • pain-predominant  (N=20); 
  • orthostasis-predominant  (N=20).
• Not pregnant by subject self-report at time of consent.
• Have the ability to provide informed consent.
• Have the ability to complete all aspects of this trial.
• Have access to an iPhone, iPad, or Android device.  
• Have no contraindicating comorbid health condition which would interfere with the proper use of the Muse-S™ system, as determined by the clinical investigators.

• Individuals < 18 years old.
• Used an investigational drug within the past 30 days.
• Anyone that is not on a stable dose of medication for anxiety, depression or sleep.
• Currently (within the past 3 weeks) been practicing mindfulness training on a weekly/regular basis.
• Currently (within 3 weeks) has been enrolled in another clinical or research program which intervenes on the patients’ QOL, or stress.
• An unstable medical or mental health condition as determined by the physician investigator.

Eligibility last updated 2/1/22. Questions regarding updates should be directed to the study team contact.