A Master Protocol Assessing the Safety, Tolerability and Efficacy of Anti-Spike (S) SARS-COV-2 Monoclonal Antibodies for the Treatment of Hospitalized Patients with COVID-19
A Study to Assess the Safety, Tolerability and Effectiveness of Monoclonal Antibodies to Treat Hospitalized Patients with COVID-19
- Has provided informed consent (signed by study patient or legally acceptable representative).
- Male or female adult ≥ 18 years of age (or country’s legal age of adulthood) at randomization.
- Laboratory-confirmed SARS-CoV-2 infection as determined by a RT-PCR result from any specimen (or other commercial or public health assay) ≤ 72 hours from randomization and no alternative explanation for current clinical condition.
- COVID-19 symptom onset ≤ 7 days.
- Hospitalized for COVID-19 illness for < 72 hours with at least 1 of the following at randomization; patients meeting more than one criterion will be categorized in the most severely affected category:
- Cohort 1: Maintains O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device;
- Cohort 2: High-intensity oxygen therapy without mechanical ventilation, where high-intensity is defined as receiving supplemental oxygen delivered by 1 of the following devices:
- Non-rebreather mask (with an SpO2 ≤ 96% while receiving an oxygen flow rate of at least 10 L/min).
- High-flow device (e.g., AIRVO™ or Optiflow™) with at least 50% FiO2.
- Non-invasive ventilator, including continuous positive airway pressure (CPAP), to treat hypoxemia (excluding isolated use for sleep-disordered breathing).
- Cohort 3: On mechanical ventilation
- Phase 1 only: Patients maintaining O2 saturation > 94% on room air.
- In the opinion of the investigator, unlikely to survive for > 48 hours from screening.
- Receiving extracorporeal membrane oxygenation (ECMO).
- Has new-onset stroke or seizure disorder during hospitalization.
- Initiated on renal replacement therapy due to COVID-19.
- Has circulatory shock requiring vasopressors at randomization.
- Note: Patients who require vasopressors for sedation-related hypotension or reasons other than circulatory shock may be eligible in this study.
- Patients who have received convalescent plasma or IVIG in the past 5 months or plan to receive during the study period for any indication.
- Participation in a clinical research study, including any double-blind study, evaluating an investigational product within 30 days and less than 5 half-lives of the investigational product prior to the screening visit.
- Note: The use of remdesivir, hydroxychloroquine, or other treatments (except for COVID- 19 convalescent plasma or IVIG) being used for COVID-19 treatments in the context of the local standard-of-care or an open-label study or compassionate use protocol is permitted.
- Any physical examination findings, history of illness, and/or concomitant medications that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the patient by their participation in the study.
- Known allergy or hypersensitivity to components of study drug.
- Pregnant or breastfeeding women.
- Continued sexual activity in women of childbearing potential (WOCBP)* or sexually active men who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 6 months after the last dose.
- Highly effective contraceptive measures in women include:
- Stable use of combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal, transdermal) or progestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition of ovulation initiated 2 or more menstrual cycles prior to screening;
- Intrauterine device (IUD);
- Intrauterine hormone-releasing system (IUS);
- Bilateral tubal ligation;
- Vasectomized partner,† and/or;
- Sexual abstinence‡,§;
- Male study participants with WOCBP partners are required to use condoms unless they are vasectomized† or practice sexual abstinence.‡,§.
* WOCBP are defined as women who are fertile following menarche until becoming postmenopausal, unless permanently sterile. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient to determine the occurrence of a postmenopausal state. The above definitions are according to Clinical Trial Facilitation Group (CTFG) guidance. Pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy.
† Vasectomized partner or vasectomized study participant must have received medical assessment of the surgical success.
‡ Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study drugs. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient.
§ Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhea method (LAM) are not acceptable methods of contraception. Female condom and male condom should not be used together.
ACTIV-6: COVID-19 Study of Repurposed Medications
• Completed Informed Consent
• Age ≥ 30 years old
• Confirmed SARS-CoV-2 infection by any authorized or approved polymerase chain reaction (PCR) or antigen test collected within 10 days of screening
• Two or more current symptoms of acute infection for ≤7 days. Symptoms include the following: fatigue, dyspnea, fever, cough, nausea, vomiting, diarrhea, body aches, chills, headache, sore throat, nasal symptoms, new loss of sense of taste or smell
• Prior diagnosis of COVID-19 infection (> 10 days from screening)
• Current or recent (within 10 days of screening) hospitalization
• Known allergy/sensitivity or any hypersensitivity to components of the study drug or placebo
• Known contraindication(s) to study drug including prohibited concomitant medications
COVID in the Community - Epidemiology of COVID-19 in Olmsted County
COVID in the Community (Enrolling by Invitation Only)
- Member of identified high risk population; i.e., employees of long-term care facilities, first responders, health care workers, and day care providers.
- Known clinically-diagnosed COVID-19 infection.
A Phase 3 Randomized, Placebo-Controlled Study of Lenzilumab in Hospitalized Patients With Severe and Critical COVID-19 Pneumonia (HGEN003-06)
A Study to Evaluate Effectiveness and Safety of Lenzilumab in Hospitalized Patients with COVID-19 Pneumonia (Enrolling by Invitation Only)
- Adults 18 years of age and older who are capable of providing informed consent or have a proxy capable of giving consent for them. See Section 10.1 for details on the consenting process for subjects with COVID-19.
- Virologic confirmation of SARS-CoV-2 infection via any diagnostic test for SARS-CoV- 2 authorized by US FDA or other national regulatory agency or ministry of health (e.g., qualitative SARS-CoV-2 real time polymerase chain reaction (RT-PCR), nucleic acid amplification (molecular) test, etc.) assessed locally per institution standard of care, prior to randomization.
- Pneumonia diagnosed by chest x-ray or computed tomography (CT) revealing infiltrates consistent with pneumonia. Note that a CT scan may be used if available, but is not required.
- Subject must have an SpO2 ≤ 94% on room air and/or require supplemental oxygen (including high-flow oxygen support or NPPV) to be eligible.
- Subject is hospitalized and has not required invasive mechanical ventilation during this hospitalization.
- Subject has not participated in other clinical trials for COVID-19 using an immunomodulating monoclonal antibody or kinase inhibitor. Subjects on corticosteroids, convalescent plasma, remdesivir or other anti-virals and/or hydroxychloroquine with or without azithromycin are not excluded from the study. Agents that have received emergency use authorization or approval from the FDA or are considered by the study site to be standard of care treatment at the institution for COVID-19 are permitted provided the agent is not an immunomodulating monoclonal antibody or kinase inhibitor. Participation in clinical trials with remdesivir or convalescent plasma is permitted provided the subject meets all other eligibility criteria.
- Females of childbearing potential must have a negative urine or serum pregnancy test at screening/baseline. Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for 5 months following their last dose of study drug. A negative urine pregnancy test or serum beta human chorionic gonadotropin (β-hCG) is required for all women of childbearing potential within 1 week prior to receiving first dose of study drug.
- Subject requires invasive mechanical ventilation or extracorporeal membrane oxygenation (i.e., category 2 on the ordinal scale).
- Confirmed diagnosis of bacterial pneumonia or other active/uncontrolled fungal or viral infections at screening/baseline.
- Known active tuberculosis (TB), history of incompletely treated TB or suspected or known extrapulmonary TB.
- Currently receiving treatment for hepatitis A, hepatitis B, hepatitis C or HIV infection.
- History of pulmonary alveolar proteinosis (PAP).
- Women of childbearing potential who are pregnant or breastfeeding.
- Known hypersensitivity to lenzilumab or any of its components.
- Use of any FDA approved anti-IL-6 (e.g., tocilizumab, sarilumab, sitlukimab), anti-IL-1 (e.g., anakinra, canakinumab) or kinase inhibitor (e.g., baracitinib, ibrutinib, acalabrutinib) therapy to treat COVID-19 within 8 weeks prior to randomization. Use of any neutralizing monoclonal antibodies such as bamlanivimab (LY-CoV555) or REGNCOV2 within 8 weeks prior to randomization. Subjects receiving other FDA-approved immunomodulators to treat underlying autoimmune disorders such as rheumatoid arthritis, psoriasis, ankylosing spondylitis, asthma, COPD, atopic dermatitis, multiple sclerosis, etc., would not be excluded unless there is a potential drug interaction with lenzilumab. Note: Subjects receiving convalescent plasma or corticosteroids are not excluded from the study. Note: Subjects receiving remdesivir or other anti-virals and/or hydroxychloroquine with or without azithromycin are not excluded from the study.
- Use of GM-CSF agents (e.g., sargramostim) within 2 months prior to randomization.
- Expected survival < 48h in the opinion of the investigator or subjects with Do Not Resuscitate or Do Not Intubate orders at baseline.
- Any condition that, in the opinion of the investigator, is likely to interfere with the safety and efficacy of the study treatment or puts the subject at unacceptably high risk from the study.
Multi Disciplinary Approach to Guiding Post-COVID Investigations, Education and Symptom Management (MAGPIES) Registry (MAGPIES)
A Study to Establish a Registry of Post-COVID Investigations, Education and Symptom Management
- Mayo Clinic patients with a previously confirmed infection with the novel SARS-CoV-2 virus who have been seen in the PCOC, CARP, Pulmonary for post COVID clinic, Neurology, or approval by MAGPIES research group.
- Aged 5 years and older.
- All racial and ethnic groups are eligible.
- Women with a previously confirmed infection with the novel SARS-CoV-2 virus of childbearing potential and pregnant women will be offered enrollment because there is no risk to an unborn child in this investigation.
- Lacking the capacity to consent.
- Prisoners and institutionalized individuals.
- Non-English speakers will be enrolled into the study but will not be specifically targeted.
Multi Disciplinary Approach to Guiding Post-COVID Investigations, Education and Symptom Management (MAGPIES) Registry and Biorepository
- Mayo Clinic patients with a previously confirmed infection with the novel SARS-CoV-2 virus who have been seen in the PCCOC, CARP, Pulmonary for post COVID clinic, Neurology, or approval by MAGPIES research group.
- Aged 5 years and older.
- All racial and ethnic groups are eligible.
- Lacking the capacity to consent.
- Prisoners and institutionalized individuals.
Eligibility last updated 9/8/21. Questions regarding updates should be directed to the study team contact.
Voice Signal Analysis to Screen for Depression and Anxiety in Patients with Persistent Post-COVID symptoms (Voila)
Voice Signal PASC Study
- Aged 18 years of age or older.
- Patients who have had a recent episode of COVID-19 who present to the post COVID-19 clinic.
- Access to smartphone (iOS or Android operating systems).
- Ability to complete study questionnaires and provide voice samples using a smartphone application.
- Known history of voice disorder either primary or secondary to neuromuscular or other pathology.
- Cognitively impaired patients.
- Unstable cardiovascular or pulmonary diseases.
- History of seizures.
Eligibility last updated 10/7/21. Questions regarding updates should be directed to the study team contact.
Novel Experimental COVID-19 Therapies Affecting Host Response (NECTAR)
•defined as MAP < 65 mmHg at time of randomization confirmed on two measurements 5 minutes apart OR vasopressors at or above norepinephrine equivalent of 0.1 mcg/kg/min in prior 4 hours to maintain MAP > 65 mmHg. 4. Known severe renal artery stenosis. 5. Known significant left ventricular outflow obstruction, such as obstructive hypertrophic cardiomyopathy or severe aortic or mitral stenosis. 6. Randomized in another trial evaluating RAAS modulation in the prior 30 days TRV027-specific exclusion criteria: 1. Participants on ARBs will be excluded from this study arm. 2. Patient unable to participate or declines participation in the TRV027 arm. 3. History of sensitivity (including angioedema) or allergic reaction to medication targeting the RAAS system including study medications or other allergy in the opinion of the investigator that contraindicates participation (not applicable to fostamatinib arm) 4. Hemodynamic instability
•defined as MAP < 65 mmHg at time of randomization confirmed on two measurements 5 minutes apart OR vasopressors at or above norepinephrine equivalent of 0.1 mcg/kg/min in prior 4 hours to maintain MAP > 65 mmHg. 5. Known severe renal artery stenosis. 6. Known significant left ventricular outflow obstruction, such as obstructive hypertrophic cardiomyopathy or severe aortic or mitral stenosis. 7. Randomized in another trial evaluating RAAS modulation in the prior 30 days Fostamatinib specific exclusion criteria: 1. AST or ALT ≥ 5 × upper limit of normal (ULN) or ALT or AST ≥ 3 × ULN and total bilirubin ≥ 2 × ULN 2. SBP > 160 mmHg or DBP > 100 mmHg at the time of screening and randomization 3. ANC < 1000/mL 4. Patient requires use of strong CYP3A modulators from Table above (Clarithromycin, Indinavir, Itraconazole, Ketoconazole, Nefazodone, Nelfinavir, Ritonavir, Saquinavir, Telithromycin, Troleandomycin, Carbamazepine, Efavirenz, Enzalutamide, Modafinil, Nevirapine, Oxcarbazepine, Phenobarbital, Phenytoin, Rifabutin, Rifampin, St. John's Wort, or Troglitazone). 5. Patient unable to participate or declines participation in the fostamatinib arm.
Evaluation of Point-of-Care (EPOC) for COVID-19 ((EPOC))
• Age ≥ 18 years.
• Informed consent by the patient or the patient's legally authorized representative (LAR) for up to 4 fingersticks for POC testing and a blood draw for stored blood samples.
• SARS-CoV-2 infection, documented by a nucleic acid test (NAT) or equivalent testing within 3 days prior to consent OR documented by NAT or equivalent testing more than 3 days prior to consent AND progressive disease suggestive of ongoing SARS-CoV-2 infection per the responsible investigator. (For non-NAT tests, only those deemed with equivalent specificity to NAT by the protocol team will be allowed. A central list of allowed non-NAT tests is maintained for TICO and that list will also be used for this protocol.)
• Duration of symptoms attributable to COVID-19 ≤ 12 days per the responsible investigator.
• Requiring admission for inpatient hospital acute medical care for clinical manifestations of COVID-19, per the responsible investigator, and NOT for purely public health or quarantine purposes.
• Prior receipt of SARS-CoV-2 hIVIG, convalescent plasma from a person who recovered from COVID-19, or SARS-CoV-2 nMAb within 6 months of the blood draws for testing as part of this protocol.
• Disease severity beyond that of stratum 1 in the TICO trial. This includes the following conditions: 1. stroke 2. meningitis 3. encephalitis 4. myelitis 5. myocardial infarction 6. myocarditis 7. pericarditis 8. symptomatic congestive heart failure (CHF; New York Heart Association [NYHA] class III-IV) 9. arterial or deep venous thrombosis or pulmonary embolism
• Current requirement for any of the following: 1. high-flow supplemental oxygen 2. non-invasive ventilation 3. invasive mechanical ventilation 4. extracorporeal membrane oxygenation 5. mechanical circulatory support 6. vasopressor therapy 7. commencement of renal replacement therapy at this admission (i.e., not patients on chronic renal replacement therapy).
• In the opinion of the responsible investigator, any condition for which, participation would not be in the best interest of the participant or that could limit protocol specified assessments.
Understanding Coronavirus Disease 2019 (Overcoming COVID-19) in US Children
A Study to Expand Understanding of Coronavirus in U.S. Children (Enrolling by Invitation Only)
- Admission to the hospital at any point during illness.
- ≤ 25 years of age (as of October 15, 2020 only patients < 21 years of age are eligible).
- Hospitalization is associated with SARS-CoV-2 with either:
- SARS-CoV-2 positive test (PCR or antibody) prior to, on admission or during hospitalization; OR
- Strong clinical suspicion (with confirmed exposure) that complications are due to COVID-19 despite negative SARS-CoV-2 test.
- (as of October 15, 2020) Symptoms or signs of disease thought to be due to COVID-19 or MIS-C OR an asymptomatic patient with BCH coordinating site approval.
- Never tested for SARS-CoV-2.
- Hospitalization is associated with a non-COVID-related acute disorder that may result in significant changes in their immune response (e.g., burns, crush injury, major trauma) (exclusion criteria 3-6 added for patients enrolled October 15th, 2020 onwards).
- Nosocomial SARS-CoV-2 infection.
- Acquired immune compromise at baseline (HIV; on active chemotherapy; active cancer; on immune modulating therapy for rheumatologic, immune, or oncologic disorders or after transplantation to prevent rejection).
- Limitations on life support due to poor prognosis.
- End stage lung disease awaiting transplant or needing chronic mechanical ventilator support.
An Expanded Access, Single-Arm, Multicenter Study to Provide at Home Subcutaneous Administration of Pertuzumab and Trastuzumab Fixed-dose Combination (PH FDC SC) for Patients with HER2-Positive Breast Cancer During the COVID-19 Pandemic (AL42478)
A Study to Evaluate At Home Administration of Pertuzumab Combined with Trastuzumab to Treat Patients with HER2-Positive Breast Cancer During COVID-19 Pandemic
- Female or male patients with histologically confirmed HER2+ breast cancer who have completed chemotherapy in combination with P+H IV and are currently receiving or will be receiving maintenance P+H IV, PH FDC SC, or trastuzumab SC (regardless of remaining treatment cycles [e.g., only 1 cycle remaining]).
- HER2+ status must have been previously determined and is defined as 3+ by immunohistochemistry (IHC) and/or positive by HER2 amplification by in situ hybridization (ISH) with a ratio of ≥ 2 for the number of HER2 gene copies to the number of chromosome 17 copies.
- Patients are not restricted from restarting therapy at any time, per investigator’s discretion. However, upon re-initiation of chemotherapy patients will be discontinued from this study.
- Signed Informed Consent Form by patient or the patient’s legally-authorized representative.
- Age ≥ 18 years at time of signing Informed Consent Form.
- Ability to comply with the study protocol, in the investigator’s judgment.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Intact skin at planned site of subcutaneous (SC) injections (thigh).
- Baseline and most recent (within 3 months) LVEF ≥ 50% measured by echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA).
- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating eggs, as defined below:
- Women must remain abstinent or use non-hormonal contraceptive methods with a failure rate of < 1% per year, or 2 effective non-hormonal contraceptive methods during the study treatment periods and for 7 months after the last dose of study treatment. Women must refrain from donating eggs during this same period;
- A woman is considered to be of childbearing potential if she is postmenarchal, has not reached a post-menopausal state (post-menopausal defined as ≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus). The definition of childbearing potential may be adapted for alignment with local guidelines or requirements;
- Examples of non-hormonal contraceptive methods with a failure rate of < 1% per year include bilateral tubal ligation, male sterilization (with appropriate post-vasectomy documentation of the absence of sperm in the ejaculate) and copper intrauterine devices (IUDs);
- The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or post-ovulation methods) and withdrawal are not acceptable methods of contraception.
- For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm, as defined below:
- With female partners of childbearing potential or pregnant female partners,men must remain abstinent or use a condom during the study treatment periods and for seven months after the last dose of study treatment to avoid exposing the embryo. Men must refrain from donating sperm during this same period;
- The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or post-ovulation methods) and withdrawal are not acceptable methods of preventing drug exposure.
- Current or prior history of active malignancy (other than current breast cancer) within the last 5 years. Appropriately treated non-melanoma skin cancer; in situ carcinomas, including cervix, colon, or skin; or Stage I uterine cancer within the last 5 years are allowed.
- Investigational treatment within 4 weeks of enrollment.
- Patients with any severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infections should not be enrolled in the trial (in the current situation, this also applies to patients with suspected or confirmed COVID-19 infection).
- Patients with suspected or confirmed COVID-19 may be re-screened for eligibility following physician-prescribed COVID-19 treatment and/or quarantine and following a negative COVID-19 real-time reverse transcription polymerase chain reaction (rRT-PCR) test.
- Patients who may have had a recent episode of thromboembolism and are still trying to optimize the anticoagulation dose and/or have not normalized their INR.
- Serious cardiac illness or medical conditions including, but not confined to, the following:
- History of NCI CTCAE v5.0 Grade ≥ 3 symptomatic congestive heart failure (CHF) or New York Heart Association (NYHA) Class ≥ II;
- High-risk uncontrolled arrhythmias (i.e., atrial tachycardia with a heart rate ≥ 100/min at rest, significant ventricular arrhythmia [ventricular tachycardia], or higher-grade atrioventricular [AV]-block, such as second-degree AV-block Type 2 [Mobitz II] or third-degree AV-block);
- Serious cardiac arrhythmia or severe conduction abnormality not controlled by adequate medication;
- Angina pectoris requiring anti-angina medication;
- Clinically significant valvular heart disease;
- Evidence of transmural infarction on electrocardiogram (ECG);
- Evidence of myocardial infarction within 12 months prior to enrollment;
- Poorly controlled hypertension (e.g., systolic > 180 mm Hg or diastolic > 100mmHg).
- History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias, such as structural heart disease (e.g., severe left ventricular systolic dysfunction [LVSD], left ventricular hypertrophy), coronary heart disease (symptomatic or with ischemia demonstrated by diagnostic testing), clinically significant electrolyte abnormalities (e.g., hypokalemia, hypomagnesemia, hypocalcemia), or family history of sudden unexplained death or long QT syndrome.
- Inadequate bone marrow function, defined by any of:
- Absolute neutrophil count (ANC) < 1.0 x 10^9/L;
- Platelet count < 100 x 10^9/L;
- Hemoglobin < 9 g/dL.
- Impaired liver function, defined by any of:
- Serum (total) bilirubin > 1.25 x upper limit of normal (ULN). In case of Gilbert’s syndrome: a total bilirubin of 2 x ULN is permitted;
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels as defined below:
- Patients with early breast cancer: AST and ALT > 1.5 x ULN;
- Patients with metastatic breast cancer: AST and ALT > 2.5 x ULN;
- Patients with liver metastases: AST and ALT > 5 x ULN;
- Albumin < 25g/L.
- Renal function with creatinine clearance < 50 mL/min using the Cockroft-Gault formula.
- Major surgical procedure unrelated to breast cancer within 28 days prior to study entry or anticipation of the need for major surgery during the course of study treatment.
- Current severe, uncontrolled systemic disease that may interfere with planned treatment (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease; wound-healing disorders).
- Pregnant or breastfeeding, or intending to become pregnant during the study or within seven months after the last dose of study treatment.
- Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator’s judgment, precludes the patient’s safe participation in, and completion of, the study.
- Known active liver disease, for example, active viral hepatitis infection (i.e., hepatitis B or hepatitis C), autoimmune hepatic disorders, or sclerosing cholangitis.
- Concurrent, serious, uncontrolled infections, or known infection with human immunodeficiency virus (HIV).
- Patients with known HIV who have adequate and stable CD4 counts on highly active antiretroviral therapy (HARRT) are allowed.
- Known hypersensitivity to any of the study drugs, excipients, and/or murine proteins or a history of severe allergic or immunological reactions; e.g., difficult to control asthma.
- Previously experienced severe injection related reactions with P + H IV, PH FDC SC and/or trastuzumab SC.
- Current chronic daily treatment with corticosteroids (dose > 10 mg methylprednisolone or equivalent excluding inhaled steroids).
Eligibility last updated 2/17/22. Questions regarding updates should be directed to the study team contact.
Evaluation of Patient-Collected Saliva as a Source for Detection of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) by Nucleic Acid Amplification Testing.
A Study to Compare Saliva and Swab Specimens in Detection of COVID Severe Acute Respiratory Syndrome
Up to 500 patients will be recruited for this study. Patients presenting for drive-through or walk-in tent specimen collection for RT-PCR testing for SARS-CoV-2 at one or more of the following SE or SW Minnesota testing sites would be enrolled:
101 Martin Luther King Jr. Drive
212 10th Ave NE
800 Medical Center Drive
2200 26th St NW
510 2nd St NW
1705 SE Broadway Ave
1407 West 4th Street
The drive-thru or tent collection sites would be selected based upon testing volumes and percent positive tests in the week preceding study commencement, in order to maximize the number of positive SARS-CoV-2 PCR results.
Evaluation of the BinaxNOW™ COVID-19 Ag Card for Rapid Detection of SARS-CoV-2 in Asymptomatic Subjects
BinaxNow™ Rapid Test
- Adults ≥ 18 years of age.
- Asymptomatic subjects presenting for SARS-CoV-2 screening as part of their routine pre-procedural testing.
- Individuals < 18 years of age.
- Symptomatic subjects.
- Subjects who are not undergoing routine SARS-CoV-2 PCR screening.
Acupuncture Therapy for COVID-Related Olfactory Loss
Acupuncture Therapy for COVID-Related Olfactory Loss
- 18 years or older.
- Patients with post-viral olfactory dysfunction > 4 weeks.
- History of positive COVID-19 PCR.
- Less than 18 years of age.
- Active sinus infection.
- New diagnosis of untreated CRS.
- Prior diagnosis of dementia or Parkinson’s disease.
- Prior head trauma or neurosurgical procedure resulting in olfactory loss.
- Patients who do not speak or read English.
- Patients unable to understand and sign the study consent.
Phase 3, Randomized, Placebo Controlled, Double-blind, Multicenter, Stratified Study of CPI-006 Plus Standard of Care Versus Placebo Plus Standard of Care in Mild to Moderately Symptomatic Hospitalized Covid-19 Patients
A Study to Evaluate CPI-006 with Standard of Care vs. Placebo with Standard of Care in Mild-to-moderately Symptomatic Hospitalized Covid-19 Patients (Enrolling by Invitation Only)
- Participants must be ≥ 18 years of age at the time of signing the informed consent.
- Confirmed positive by PCR or antigen test for SARS-CoV-2 with sample collection ≤ 10 days prior to the day of randomization. PCR is the preferred method; however other tests for SARS-CoV-2 are allowed if authorized for use in the country.
- Covid-19 illness of any duration of symptoms.
- Participant capable of understanding the study and giving informed consent. Participant capable of signing and dating the written ICF. Participant must understand and agree to comply with planned study procedures for the duration of the study. The study visits beyond Day 28 will be optional and require a separate consent.
- Hospitalized for Covid-19 illness for ≤ 5 days with mild to moderate Covid-19 symptoms, including:
- Mild: Symptoms of Covid-19 including fever, rhinorrhea, mild cough, sore throat, headache, muscle pain, malaise but not requiring supplemental oxygen;
- Moderate: Lower respiratory symptoms: shortness of breath (SOB) or signs of pneumonia or lung infiltrates based on X-ray or computed tomography (CT) scan < 50% present; and
- Meets the criteria for:
- Category 4
•Hospitalized, not requiring supplemental oxygen
•requiring ongoing medical care (Covid-19 related or otherwise); OR
- Category 5
•Hospitalized, requiring supplemental oxygen; OR
- Category 6
•Hospitalized, on non-invasive ventilation or high flow oxygen devices per 8-point ordinal scale.
- Adequate organ function, as defined by:
- CBC: ANC >1000/mm^3;
- Platelets > 75,000mm^3;
- Hgb > 9 gm/100 cc;
- Calculated creatinine clearance based on ideal body weight per Cockcroft-Gault formula or 24-hour urine ≥ 30 mL/min;
- Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≤ 5 × upper limit of normal (ULN);
- D-dimer < 10,000 ng/mL.
- Eligible participants of child-bearing age (male or female) must agree to use at least 1 medically accepted method of contraception (e.g., barrier contraceptives [condom, or diaphragm with a spermicidal gel], hormonal contraceptives [implants, injectables, combination oral contraceptives, transdermal patches, or contraceptive rings], or intrauterine devices), or agree to abstinence for 6 weeks. Female participants or the female partners of male participants who become pregnant during the study or within the protocol-specified period after their last CPI-006 administration should immediately inform their treating physicians.
- Signs of acute respiratory distress syndrome (ARDS) or respiratory failure necessitating mechanical ventilation at the time of screening (and randomization) or anticipated impending need for mechanical ventilation.
- History of severe chronic respiratory disease and requirement for long-term oxygen therapy.
- Any uncontrolled active systemic infection or hemodynamic instability requiring admission to an intensive care unit (ICU).
- Patients with malignant tumor receiving treatment, or other serious systemic diseases affecting life expectancy within 29 days of Screening.
- Receipt of cancer chemotherapy or immunomodulatory drugs including (but not limited to) biologics such as anti-CD20, anti-TNF, anti-IL6; alkylating agents (e.g., cyclophosphamide); antimetabolites (e.g., azathioprine); or chronic corticosteroid use equivalent to prednisone > 10 gm/day, during preceding 2 months.
- Note: Steroids for treatment of Covid-19 is acceptable.
- Patients who are participating in other clinical trials including participants in an extended access program (EAP).
- Active deep vein thrombosis or pulmonary embolism as confirmed by the investigator within last 6 months.
- Anticipated discharge from the hospital or transfer to another hospital which is not a study site within 72 hours of admission as confirmed by the investigator.
- Any active uncontrolled co-morbid disease that might interfere with study conduct or interpretation of findings.
- Known to be positive for HIV or positive test for chronic HBV infection (defined as positive hepatitis B surface antigen [HBsAg]) or positive test for hepatitis C antibody.
- Convalescent plasma (CCP) or anti-SARS-CoV-2 monoclonal antibodies administered less than 24 hours prior to randomization. Patient must have recovered from any adverse events related to CCP treatment. Received chloroquine or hydroxychloroquine within last 7 days or during the study.
- Pregnancy or breast feeding.
Dendritic Cell Enumeration and Function, and Multi-Omics Analysis in COVID-19 Patients (DCEFMO)
COVID19 Immunology and Omics Study
- Adult patients ≥ 18 years old.
- COVID-19+ and COVID-19- individuals (controls), as determined by qPCR.
- Individuals < 18 years of age.
- Pregnant women.
- Individuals with ambiguous COVID-19 result by qPCR.
- Individuals who have received one, or both doses of the Covid 19 vaccine.
- Individuals who are recieving a monoclonal antibody infusion.
Outpatient Treatment of SARS-CoV-2 With Ivermectin, Fluvoxamine, and Metformin (COVID-19)
1) Determine whether metformin can prevent ED utilization for Covid-19 disease in persons with SARS-CoV-2 infection; 2) Determine whether metformin is effective post-exposure prophylaxis of SARS-CoV-2 infection in persons with close contact to someone with SARS-CoV-2 infection
• Positive laboratory test for active SARS-CoV-2 viral infection based on local laboratory standard (i.e. +PCR) within 3 days of randomization.
• No known history of confirmed SARS-CoV-2 infection
• BMI >= 25kg/m2 by self-report height/weight or >= 23kg/m2 in patients who self-identify in South Asian or Latinx background.
• Willing and able to comply with study procedures (i.e. swallow pills)
• Has an address and electronic device for communication
• GFR>45ml/min within 2 weeks for patients >75 years old, or with history of heart, kidney, or liver failure.
• Hospitalized, for COVID-19 or other reasons.
• Symptom onset greater than 7 days before randomization (symptoms not required for inclusion).
• Immune compromised state (solid organ transplant, bone marrow transplant, AIDS, on high dose steroids)
• Hepatic impairment (Child-Pugh B and C) or other condition that, in the opinion of the investigator, would affect safety
• Inability to obtain informed consent
• Enrollment in another blinded Randomized Controlled Trial for COVID-19
• Already received an effective (FDA approved/EUA*) therapy for COVID-19 (currently monoclonal antibody treatment)
• Alcohol use disorder
• Other unstable medical condition or combination of home medications that in the view of the PI make it unsafe for the individual to participate
• History of severe kidney disease i.e.: 1. Stage 4 or 5 CKD, or Estimated Glomerular Filtration Rate (eGFR) of < 45ml/min/1.73 m2 2. Other kidney disease that in the opinion of the investigator would affect clearance
• Unstable heart failure (Stage 3 or 4 heart failure)
• Allergic reaction to metformin, fluvoxamine, or ivermectin in the past
• Bipolar disease: individuals who report they have bipolar disorder or are taking medication for bipolar disorder (lithium, valproate, high-dose antipsychotic), unless the investigator concludes that the risk for mania is unlikely
• Current loa loa or onchocerciasis infection
• Typhoid, BCG, or cholera vaccination within the 14-days or 3 days after Medication Exclusions:
• Cimetidine, hydroxychloroquine, insulin, sulfonylurea, dolutegravir, patiromer, ranolazine, tafenoquine.
• Rasagiline, selegiline, or monoamine oxidase inhibitors, linezolid, methadone
• Duloxetine, methylene blue
• Tizanidine, ramelteon, sodium picosulfate
• Alosetron, agomelatine, bromopride, dapoxetine, tamsimelteon, thioridazine, urokinase, pimozide The following medications may not need to be excluded when dose for that individual is considered alongside the low dose of fluvoxamine being used and other medications being used. The PI or site PI may review and decide if the patient should be excluded from the fluvoxamine arms: 1. Taking SSRIs, SNRIs, or tricyclic antidepressants, unless these are at a low dose such that a study investigator concludes that a clinically significant interaction with fluvoxamine (ie either serotonin syndrome or TCA overdose) is unlikely (examples: participant takes escitalopram but only at 10mg daily; that dose plus 100mg fluvoxamine would be insufficient to cause serotonin syndrome; or, participant takes amitriptyline but only at 25mg nightly; even if fluvoxamine inhibits its metabolism, it would be an insufficient dose to cause QTc prolongation or problematic side effects). Risk Class C, monitor therapy. 2. Individuals who take alprazolam or diazepam and are unwilling to cut the medication by 20% (rationale: fluvoxamine modestly inhibits the metabolism of these drugs). Risk Class C, monitor therapy 3. Participants taking theophylline, clozapine, or olanzapine (drugs with a narrow therapeutic index that are primarily metabolized by CYP 1A2, which is inhibited by fluvoxamine) will be reviewed with a study investigator and excluded unless the investigator concludes that the risk to the participant is low (this would be unlikely; example: participant takes clozapine only as needed and is willing to avoid it for the 14 days of the study). 4. Patients will be advised that there is a small risk that the following substances will be affected by fluvoxamine, but that significant effects are not likely at the low dose being used: caffeine, nicotine, melatonin. Risk Class C, monitor therapy 5. Taking warfarin-also known as Coumadin, NSAIDs, and Aspirin (rationale: increased risk of bleeding), phenytoin (rationale: fluvoxamine inhibits its metabolism), clopidogrel (rationale: fluvoxamine inhibits its metabolism from pro-drug to active drug which raises risk of cardiovascular events), and St John's wort (rationale: fluvoxamine + St John's wort are considered contraindicated because of the risk of serotonin syndrome) Risk C, monitor therapy.
Randomized Master Protocol for Immune Modulators for Treating COVID-19 (ACTIV-1 IM)
A Study to Evaluate Agents to Treat Moderately or Severely Ill Patients with Severe Acute Respiratory Syndrome Coronavirus 2
- Admitted to a hospital or awaiting admission in the ED with symptoms suggestive of COVID-19.
- 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 adults ≥ 18 years of age at time of enrollment.
- Has laboratory-confirmed (within 14 days prior to enrollment) SARS-CoV-2 infection as determined by PCR or other commercial or public health assay in any specimen.
- Ongoing illness of any duration, and at least one of the following:
- Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.).
- Blood oxygen saturation (SpO2) ≤ 94% on room air.
- Requiring supplemental oxygen.
- Requiring mechanical ventilation or ECMO.
- Women of childbearing potential must agree to either abstinence or use at least one primary form of contraception not including hormonal contraception from the time of screening through Day 60.
- Agrees to not participate in another intervention trial for the treatment of COVID-19 through Day 60.
- ALT or AST > 5 times the upper limit of normal.
- Estimated glomerular filtration rate (eGFR) < 30 mL/min (including patients receiving hemodialysis or hemofiltration).
- Neutropenia (absolute neutrophil count < 1000 cells/μL) (<1.0 x 10^3/μL or < 1.0 GI/L).
- Lymphopenia (absolute lymphocyte count < 200 cells/μL) (< 0.20 x 10^3/μL or < 0.20 GI/L).
- Pregnancy or breast feeding.
- Anticipated discharge from the hospital or transfer to another hospital which is not a study site within 72 hours.
- Known Allergy to any study medication.
- Received cytotoxic or biologic treatments (such as anti-interleukin-1 [IL-1], anti-IL-6 [tocilizumab or sarilumab], IL-17, or T-cell or B-cell targeted therapies (e.g., rituximab), tyrosine kinase inhibitors including baricitinib, TNF inhibitors, or interferon within 4 weeks or 5 half-lives prior to screening. Steroid dependency defined as need for prednisone at a dose > 10 mg (or equivalent) for > 1 month within 2 weeks of screening is exclusionary.
- Note 1: Dexamethasone (at a dose of 6 mg per day for up to 10 days) is permitted for the treatment of COVID-19 in patients who are already mechanically ventilated and in patients who require supplemental oxygen at screening, but who are not mechanically ventilated in accordance with national guidelines.
- Note 2: Infusion of convalescent plasma is also allowed.
- Based on medical history and concomitant therapies that would suggest infection, have suspected clinical diagnosis of current active tuberculosis (TB) or, if known, latent TB treated for less than 4 weeks with appropriate anti-tuberculosis therapy per local guidelines (by history only, no screening required).
- Based on medical history and concomitant therapies that would suggest infection, suspected serious, active bacterial, fungal, viral (including, but not limited to, active HBV, HCV, or HIV/AIDS).
- Have received any live vaccine (that is, live attenuated) within 3 months before screening, or intend to receive a live vaccine (or live attenuated) during the study.
- Note: Use of non-live (inactivated) vaccinations is allowed for all participants.
- Severe hepatic impairment (defined as liver cirrhosis Child stage C).
- Current severe heart failure (New York Heart Association [NYHA] III-IV).
- In the Investigator's judgment, the patient has any advanced organ dysfunction that would not make participation appropriate.
An Observational Cohort Study to Determine Late Outcomes and Immunological Responses after Infection with SARS-CoV-2 in Children with and without Multisystem Inflammatory Syndrome (MIS-C) (PRISM)
A Study to Determine Late Outcomes and Immunological Responses in Children With/Without Multisystem Inflammatory Syndrome After SARS-CoV-2
- Participants < 21 years AND meets one or more of the following criteria:
- SARS-CoV-2 detection from a respiratory specimen; and/or
- Meets criteria for MIS-C; and/or
- Meets criteria for MIS-C, except has involvement of only 1 organ system.
- Cases meeting clinical criteria for MIS-C but without known SARS-CoV-2 exposure, and who are being treated as MIS-C by the treating physician, but with negative SARS-CoV-2 PCR and pending or negative antibody testing, may be enrolled as participants. If subsequent antibody testing is positive, cases will be labelled as confirmed MIS-C.
- If SARS-CoV-2 antibody testing is negative, participants will be labeled at the end of the study as suspected/not confirmed MIS-C.
- Participant and/or parent/guardian who is not able to understand or be willing to provide informed consent and where applicable assent.
- Note, for this observational cohort study, participation in other COVID-19 studies is not an automatic exclusionary criterion.
- Nonetheless, blood draw restrictions will be strictly adhered to.
Understanding Social Determinants of Health and Patients’ Perspectives on Barriers to Utilizing Telehealth During COVID-19 Pandemic (NSITE)
NSITE: Novel Strategies to Increase Telehealth Engagement
- Male or female, age ≥ 18 years as of April 2020.
- Patient at Mayo Clinic (Arizona, Florida or Minnesota) or Mayo Clinic Health System.
- Has not utilized telehealth services since April 2020 but attended face-to-face appointments only for non-emergent outpatient clinical care.
- Anyone not meeting inclusion criteria.
Understanding the Long-term Impact of COVID-19 on the Brain Through Advanced MR Imaging and Spectroscopy (COVID-BRAIN)
A Study to Evaluate COVID Brain Advanced Imaging Network
- Participants must be 18 years or older.
- Participants must understand and cooperate with requirements of the study in the opinion of the investigators and must be able to provide written informed consent.
- Individuals who had no known COVID-19 exposure (for controls) or had PCR or antibody confirmed COVID-19 who present with neurological symptoms in the months after infection and fit one of the following criteria during the acute phase of the infection:
- ambulatory with no or mild symptoms;
- hospitalized but on no oxygen; or
- hospitalized but on oxygen administered via a nasal cannula, mask or non-invasive ventilation; i.e., individuals with WHO Ordinal Scale40 scores 0-5.
- English or Spanish speaking (based on self-stated primary language).
- Clear of any contraindications for MRI.
- Patients under 18 years of age.
- Medical conditions likely to interfere with the study, including chronic neurologic conditions, restless leg syndrome, structural abnormalities such as subdural hematoma, intracranial neoplasms, end-stage renal disease, severe chronic obstructive pulmonary disease (COPD) needing oxygen, end-stage liver disease, active psychiatric illness, active drug abuse, stroke unrelated to COVID-19 or heart attack 6 months before study enrollment, active cancer, concurrent illnesses or treatments interfering with cognitive function such as dementia or normal pressure hydrocephalus.
- Individuals who had COVID-19 and required mechanical ventilation.
- Pregnant women.
- Inability to undergo MRI scanning, including but not limited to claustrophobia, unable to remain still in an MRI scanner for more than 30 minutes, presence of paramagnetic substances or pacemakers in body, weight over 300 lbs.
- Inability to adhere to study protocol for whatever reason.
Colon and Rectal Surgery Patient Fitness and Prehabilitation Program Survey during COVID 19 Pandemic (POWER survey)
Evaluation of patients perceived health and fitness prior to surgery during the COIVD 19 pandemic
Inclusion Criteria: Adults patients (> 18 years old) being seen in colon and rectal surgery clinic for a surgical condition requiring an inpatient operation.
Children (age < 18 years old)
Patients with surgical conditions requiring an outpatient operation
Clinical and Neurocognitive Correlates to Seropositivity for SARS-CoV-2 IgM/IgG Antibodies in Bipolar Disorder (COVID)
A Study to Evaluate Positive SARS-CoV-2 Antibodies in Subjects with Bipolar Disorder
- Age, 18-65 years.
- Diagnosis of BD-I or BD-II, or SCZ-BD by DSM-IV (SCID confirmed). Participants of the Bipolar Biobank (IRB # 08-008794) are patients with existing SCID results and participants enrolling to the MoStGEN protocol (IRB # 20-001658) are required to complete a SCID; thus they will not be required to repeat the SCID assessment. Only patients without a previous SCID will be interviewed to complete it.
- Subjects willing to provide consent to be blood-tested for SARS-CoV-2 IgG/IgM on each of the three visits.
- Inability to understand English.
- Inability or unwillingness to provide informed consent or scoring less than 80% on the comprehension assessment (CA) form.
- Unwilling to consent to providing bio-specimens to be stored in the biobank for an indefinite amount of time and to be used in future research studies of as yet unknown design.
- Actively psychotic (i.e., paranoia, perceptual disturbances, delusional ideas, impaired judgment) or active suicidal behavior (including suicidal ideation or planning).
- Involuntary patients.
- Women with known pregnancy. (Due to the lack of conclusive data regarding the quality of antibody response during pregnancy, we considered it appropriate the exclusion of women with known pregnancy from this study).
Quantification of SARS-CoV-2 RNA in Human Saliva (COVID Saliva)
A Study to Measure SARS-CoV-2 RNA in Human Saliva
- Adults, ≥ 18 years if age.
- Subjects who have respiratory tract specimens positive for the SARS-CoV-2 virus.
- Individuals < 18 years of age.
- Unable to provide consent.
Risks of COVID19 in the Pregnant Population (C19 PR)
A Study to Evaluate COVID19 Pregnancy Risks
- Pregnant females age 18-45 years and their infants.
- Willing and able to provide written informed consent.
- Pregnant and planning to deliver at Mayo Clinic.
- Positive for HIV, HBV or TB.
- Delivery not planned at Mayo Clinic.
Mayo Clinic Experience of Tele-Medicine in an Advanced Prostate Cancer Clinic During the COVID-19 Pandemic (TM-APC-S)
Tele-Medicine in an Advanced Prostate Cancer Clinic
- Any patient with advanced prostate cancer presented to us through Tele-consult during COVID-19 for a consult.
- Patients consented to be enrolled in the study
- Patients that refuse to be enrolled in the study
Pandemic Response Optimizing Technology and Ethics for Coronavirus Teams Implementing Novel Genetics (PROTECTING) (PROTECTING)
A Study to Evaluate the Pandemic Response Optimizing Technology and Ethics for Coronavirus Teams Implementing Novel Genetics
- Ability to converse in English.
- Legal adult 18 years of age or older who have the capacity to consent to participating in this study.
- To meet Aims 1 and 2 and to ensure balanced stakeholder perspectives are gathered, eligible participants will be screened to identify employees of Mayo Clinic (currently employed by Mayo Clinic or employed by Mayo Clinic within the last five years) and non-employee (currently not employed by Mayo Clinic or employed by Mayo Clinic in the last five years).
- To meet the aims of this study, equilibrium of the number of eligible participants in the groups of the subject populations identified is desirable thus selective sampling of the groups will be implemented during recruitment
- Unable to converse in English.
- Individuals less than 18 years of age or who do not have the capacity to consent to participating in this study.
- Legally authorized representatives of contributors to the biobank
- To meet Aims 1 and 2, eligible participants in subject population group 1 will be screened to identify current participation in the Mayo Clinic Center for Individualized Medicine Biobank.
- Individuals who have donated to the Mayo Clinic.
- Biobank will be excluded from this study to safeguard an unbiased data collection on biospecimen research and perceptions of consent and voluntariness during a pandemic.
Zinc Versus Multivitamin Micronutrient Supplementation to Support Immune Health in the Setting of COVID-19 Pandemic: A randomized study (Zn COVID Study)
A COVID Study to Compare Impact of Zinc Supplementation versus Multivitamin to Support Immune Health
- Age ≥ 50 years old OR primary healthcare professional (defined as having a job that has had direct patient contact during the COVID-19 pandemic) and ≥ 18 years old.
- No symptoms of COVID-19 (a fever of 100.0 degrees F or greater, OR a new cough, OR new shortness of breath, OR new sore throat, OR new diarrhea, OR new fast breathing (respiratory distress), OR new chills, OR new muscle aches (myalgias), OR new loss of smell, OR new change or loss of taste sensation) in the past 7 days.
- Have a negative Elecsys Anti-SARS-CoV-2 immunoassay antibody test at screening .
- Have not had close contact with a person with a LABORATORY CONFIRMED case of COVID-19 (Close contact is defined by CDC as: being within approximately 6 feet of a COVID-19 patient for a prolonged period of time (more than 5 minutes) or having direct contact with infectious secretions of a COVID-19 patient (e.g., being coughed on)) in the last 14 days.
- Mayo Clinic patient who has a patient online account set up or is willing to set up an online account.
- Must have a valid email address and internet service
- History of positive or indeterminate COVID PCR test prior to screening or positive or indeterminate Elecsys Anti-SARS-CoV-2 immunoassay antibody test at screening.
- Active symptoms of COVID ((a fever of 100.0 degrees F or greater, OR a new cough, OR new shortness of breath, OR new sore throat, OR new diarrhea, OR new fast breathing (respiratory distress), OR new chills, OR new muscle aches (myalgias), OR new loss of smell, OR new change or loss of taste sensation)) in past 7 days.
- Known intolerance to Centrum multivitamins or Zinc supplement from prior exposure.
- Inability to complete follow-up questions or grant access to electronic health record for surveillance.
- Have had close contact with a person with a LABORATORY CONFIRMED case of COVID-19 in past 14 days.
- Current or former smoker less than 5 years ago.
- Pregnant or breastfeeding.
- Any subject with known immunosuppressed state, including:
- A history of solid organ or bone marrow transplantation;
- Subjects currently receiving chemotherapy;
- Current rheumatologic or autoimmune illness requiring treatment with glucocorticoids, antimetabolite agents (methotrexate, azathioprine, mercaptopurine, fluorouracil, mycophenolate, leflunomide), IMIDs (lenalidomide, thalidomide, pomalidomide), calcineurin inhibitors (tacrolimus, cyclosporine), mTOR inhibitors (sirolimus, everolimus), or any monoclonal antibody drugs (including any drug given intravenously or subcutaneously) for the purpose of immunosuppression;
- Subjects with HIV or primary immunodeficiency syndromes.
Colchicine Coronavirus SARS-CoV2 Trial (COLCORONA) (COLCORONA)
A Study to Evaluate the Efficacy and Safety of Colchicine on Coronavirus SARS-CoV2 Positive Adults
- Males and females, at least 40 years of age, capable and willing to provide informed consent
- Patient must have received a diagnosis of COVID-19 infection within the last 24 hours
- Outpatient setting (not currently hospitalized or under immediate consideration for hospitalization)
- Patient must possess at least one of the following high-risk criteria:
- 70 years or more of age, obesity (BMI ≥ 30 kg/m2)
- Diabetes mellitus
- Uncontrolled hypertension (systolic blood pressure ≥150 mm Hg)
- Known respiratory disease (including asthma or chronic obstructive pulmonary disease)
- Known heart failure
- Known coronary disease
- Fever of ≥38.4°C within the last 48 hours
- Dyspnea at the time of presentation
- The combination of high neutrophil count and low lymphocyte count
- Female patient is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile, or is of childbearing potential and practicing at least one method of contraception and preferably two complementary forms of contraception including a barrier method (e.g. male or female condoms, spermicides, sponges, foams, jellies, diaphragm, intrauterine device (IUD)) throughout the study and for 30 days after study completion
- Patient must be able and willing to comply with the requirements of this study protocol.
- Patient currently hospitalized or under immediate consideration for hospitalization
- Patient currently in shock or with hemodynamic instability
- Patient with inflammatory bowel disease (Crohn's disease or ulcerative colitis), chronic diarrhea or malabsorption
- Patient with pre-existent progressive neuromuscular disease
- Estimated Glomerular filtration rate (eGFR), using the MDRD equation for all subjects being considered for enrollment, with a cut-off of < 30 mL/m in/1.73m2
- Patient with a history of cirrhosis, chronic active hepatitis or severe hepatic disease
- Female patient who is pregnant, or breast-feeding or is considering becoming pregnant during the study or for 6 months after the last dose of study medication
- Patient currently taking colchicine for other indications (mainly chronic indications represented by Familial Mediterranean Fever or gout)
- Patient with a history of an allergic reaction or significant sensitivity to colchicine
- Patient undergoing chemotherapy for cancer
- Patient is considered by the investigator, for any reason, to be an unsuitable candidate for the study.
First Responder Resiliency Program for Health Care Professionals During a Pandemic
A Study to Evaluate a Resiliency Program for Healthcare Professionals During a Pandemic
- 18 years of age or older at the time of consent.
- Frontline healthcare professional.
- Have access to an Apple or Android device.
- Not pregnant by subject self-report at time of consent.
- Have the ability to provide informed consent.
- Have no contraindicating comorbid health condition as determined by the clinical investigators.
- Currently (within the past 3 weeks) been practicing mindfulness training on a weekly/regular basis.
- Currently (within the past 3 weeks) been undergoing an additional program (e.g., CAM) to improve quality of life or sleep.
- Currently (within 3 weeks) been enrolled in another clinical or research program (e.g., CAM) which intervenes on the patients’ QOL, stress or sleep.
- An unstable medical or mental health condition as determined by the physician investigator.