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Evaluation of Point-of-Care (EPOC) for COVID-19 ((EPOC))
The overall objective of this protocol is to assess the feasibility of using POC antibody tests for patient management.
All
18 Years and over
N/A
NCT05227404
Inclusion Criteria:
• 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.
Exclusion Criteria:
• 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:
• stroke
• meningitis
• encephalitis
• myelitis
• myocardial infarction
• myocarditis
• pericarditis
• symptomatic congestive heart failure (CHF; New York Heart Association [NYHA] class III-IV)
• arterial or deep venous thrombosis or pulmonary embolism
• Current requirement for any of the following:
• high-flow supplemental oxygen
• non-invasive ventilation
• invasive mechanical ventilation
• extracorporeal membrane oxygenation
• mechanical circulatory support
• vasopressor therapy
• 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.
Diagnostic Test: LumiraDX, Diagnostic Test: RightSign, Diagnostic Test: Case Control
COVID-19, SARS CoV 2 Infection
COVID-19, SARS COV 2, COVID19 testing
Understanding the long term impact of COVID-19 on the brain by advanced MR imaging and spectroscopy
In this study, we want to learn more about what kinds of structural and chemical changes are happening in the nervous systems of people recovering from COVID-19 compared to people who have not been exposed to COVID-19.
Gulin Oz
18 Years and over
NA
RAD-2021-29124
STUDY00012571
Inclusion Criteria:
• Participants must be 18 years or older
• Participants must fall into one of the following groups: a) no known COVID-19 exposure (for controls), or b) laboratory confirmed COVID-19 who present with neurological symptoms in the months after infection and were either 1) non-hospitalized, or 2) hospitalized, but never underwent invasive (tube in throat) ventilation
• Participants must be English or Spanish speaking
• Participants must be able to provide written informed consent
• Participants must be clear of any contraindications for MRI (see exclusions) *Study not registered on Clinicaltrials.gov
Exclusion Criteria:
• Medical conditions likely to interfere with the study, including chronic neurologic conditions (such as Alzheimer disease, Parkinson's disease, ALS, HIV-Associated Neurocognitive Disorder, brain infections, or brain tumors), traumatic brain injury with loss of consciousness, end-stage kidney disease, end-stage liver disease, restless leg syndrome, chronic lung disease unrelated to COVID-19 needing oxygen, history of stroke unrelated to COVID-19, history of bipolar disorder or psychotic illness (such as schizophrenia or schizoaffective disorder)
• Individuals who had COVID-19 and required mechanical invasive 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 metallic foreign bodies or pacemakers in body, weight over 350 lbs. *Study not registered on Clinicaltrials.gov
Brain & Nervous System, COVID-19
CMRR, COVID-19, Coronavirus, MRI, MRS, SARS-CoV-2, long COVID, long-term, neurological
MET-COVID Trial METformin for Prevention and outpatient treatment of COVID-19: Does Metformin prevent severe COVID-19 disease?
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
Carolyn Bramante
All
30 Years to 85 Years old
Phase 3
NCT04510194
STUDY00011393
Inclusion Criteria:
• 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.
Exclusion Criteria:
• 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.:
• Stage 4 or 5 CKD, or Estimated Glomerular Filtration Rate (eGFR) of < 45ml/min/1.73 m2
• 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:
• 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.
• 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
• 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).
• 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
• 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.
• Additional COVID-19 treatments to exclude will be decided by a panel of at least 3 Co-Investigators on this study. The additional treatments to exclude will be documented and submitted to the IRB but may be implemented before formal IRB approval is complete. We take this approach because of the rapidly changing treatment landscape of COVID-19. Participation in the study does not prevent them from receiving such treatments after enrollment.
Drug: Metformin, Drug: Placebo, Drug: Fluvoxamine, Drug: Ivermectin
COVID-19, Infectious Diseases, Respiratory System, Covid19, SARS-CoV Infection
Covid
ACTIV-6: COVID-19 Study of Repurposed Medications
All
30 Years and over
Phase 3
NCT04885530
Inclusion Criteria:
• 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
Exclusion Criteria:
• 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
Drug: Ivermectin, Drug: Fluvoxamine, Drug: Fluticasone, Other: Placebo
Covid19
SARS-CoV-2, COVID-19, ivermectin, Placebo, Duke University Health System, Outcomes, Duke Clinical Research Institute, fluticasone, fluvoxamine, ACTIV 6, ACTIV
014 / ACTIV-3: A Multicenter, Adaptive, Randomized, Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for Hospitalized Patients with COVID-19 (TICO)
Mahsa Abassi
All
18 Years and over
Phase 3
NCT04501978
STUDY00011184
Inclusion Criteria:
• Signed informed consent.
• Positive test for COVID-19 and progressive disease suggestive of ongoing COVID-19 infection.
• Symptoms of COVID-19 for ≤ 12 days.
• Require admission to hospital for acute medical care (not for purely public health or quarantine purposes).
Exclusion Criteria:
• Patients who have received plasma from a person who recovered from COVID-19 or who have received neutralizing monoclonal antibodies at any time prior to hospitalization.
• Patients not willing to abstain from participation in other COVID-19 treatment trials until after Day 5 of the study. Co-enrollment in certain trials that compare recommended Standard of Care treatments may be allowed, based on the opinion of the study leadership team.
• Any condition which, in the opinion of the responsible investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments.
• Patients considered unable to participate in study procedures.
• Women of child-bearing potential who are not already pregnant at study entry and who are unwilling to acknowledge strong advice to abstain from sexual intercourse with men or practice appropriate contraception through 18 months of the study.
• Women of child-bearing potential who are unwilling to acknowledge the strong advice to abstain from sexual intercourse with men or practice appropriate contraception through 5 weeks of the study (PF-07304814 investigational agent).
• Pregnant women (PF-07304814 investigational agents).
• Nursing mothers (PF-07304814 investigational agents).
• Men who are unwilling to acknowledge the strong advice to abstain from sexual intercourse with women of child-bearing potential or to use barrier contraception through 18 months of the study.
• Men who are unwilling to acknowledge the strong advice to abstain from sexual intercourse with women of child-bearing potential or to use barrier contraception through 5 weeks of the study (PF-07304814 investigational agent).
• Presence at study enrollment of any of the following:
• stroke
• meningitis
• encephalitis
• myelitis
• myocardial ischemia
• myocarditis
• pericarditis
• symptomatic congestive heart failure
• arterial or deep venous thrombosis or pulmonary embolism
• Current or imminent requirement for any of the following:
• invasive mechanical ventilation
• ECMO (extracorporeal membrane oxygenation)
• Mechanical circulatory support
• vasopressor therapy
• commencement of renal replacement therapy at this admission (i.e. not patients on chronic renal replacement therapy).
• Participants with moderate to severe hepatic impairment (i.e. Child-Pugh class B or C) or acute liver failure (PF-07304814 investigational agent).
• Participants receiving any medications or substances that are strong inhibitors or inducers of cytochrome P450 (CYP) 3A4 (PF-07304814 investigational agent).
• Patients will be excluded if taking drugs which have a narrow therapeutic window that are substrates of CYP3A4, including but not limited to: astemizole, cisapride, cyclosporine, dihydroergotamine, ergotamine, pimozide, quinidine, sirolimus, tacrolimus, and terfenadine (PF-07304814 investigational agent).
• Patients with a history of deep vein thrombosis or pulmonary thrombotic embolism (Prior to initial futility assessment of PF-07304814 investigational agent).
Biological: LY3819253, Drug: Placebo, Biological: Remdesivir, Biological: VIR-7831, Biological: BRII-196/BRII-198, Biological: AZD7442, Drug: MP0420, Drug: PF-07304814
Covid19
COVID-19, COVID 19, Coronaviridae Infections, Coronavirus Infections, RNA Virus Infections, Virus Diseases, Nidovirales Infections, SARS-CoV-2, SARS Coronavirus, ACTIV-3, ACTIV3
A Phase 2/3, Two-Part, Open-Label, Dose Escalation, Age De-escalation and Randomized, Observer-Blind, Placebo-Controlled Expansion Study to Evaluate the Safety, Tolerability, Reactogenicity, and Effectiveness of mRNA-1273 SARS-CoV-2 Vaccine in Healthy Children 6 months to < 12 Years of Age (mRNA-1273-P204) - COVID-19
The Sponsor of this study, ModernaTX, is studying the mRNA-1273 vaccine for the prevention of COVID-19 in children. This study is being conducted to learn about the safety, any side effects, and how your child’s body responds to the study vaccine (the “immune response”).
Shane McAllister
Phase II/III
NCT04796896
STUDY00012613
SARS-CoV-2
COVID-19, COVID-19 Vaccine, Coronavirus, Messenger RNA, Moderna, SARS-CoV-2, SARS-CoV-2 Vaccine, Virus Diseases, mRNA-1273, mRNA-1273 vaccine
Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children per Standard of Care / (POPS): NICHD-2019-POP02 (including COVID-19 drugs) (POPS or POP02)
The majority of drugs administered to children are used off label, and PK studies to define appropriate dosing are lacking across pediatric age groups and special populations of children. Challenges associated with clinical trials in children limit the ability to conduct PK and dosing trials in this population. Studies capitalizing on standard-of-care procedures have proven successful in characterizing the PK of drugs used in children. The purpose of this study is to characterize the PK of understudied drugs administered to children per SOC as prescribed by their treating provider. This study will serve as a tool to better understand drug exposure in children receiving drugs per SOC. The data collected through this initiative will provide valuable PK and dosing information for drugs in different pediatric age groups as well as special populations of children, such as premature infants, critically ill children receiving ECMO or CRRT, children with Down syndrome and children with obesity, for which dosing may vary due to altered PK. In addition, the data collected in this study will serve as preliminary data to design and plan the best and most efficacious BPCA trials, proof-of-concept studies associated with biomarkers, and data to support applications for extramural funding. All of the drugs studied in this protocol are used as standard of care in children and are approved in adults. There will be multiple INDs held by the core study Principal Investigator: Danny Benjamin, MD, PhD (IND Sponsor) Kiser-Arena Distinguished Professor of Pediatrics, Duke University Faculty Associate Director, Duke Clinical Research Institute PO Box 17969 Durham NC 27715 Phone: 919-668-8295 Fax: 919-681-9457 danny.benjamin@duke.edu The Funding Sponsor is The National Institute of Child Health and Human Development (NICHD) NOTE: We will be participating in the COVID 19 arm of this study, which includes 6 drugs of interest (DOI). All other arms are on hold currently; and focus has been placed on the COVID 19 arm. However, in the future we may be interested in participating in other DOIs. The details of this arm of the study will be provided at the end of this document. (See Appendix P, pages 82-86 of main protocol)
Catherine Bendel
All
up to 20 Years old
NA
NCT04278404
STUDY00009884
Inclusion Criteria:
• Participant is < 21 years of age
• Parent/ Legal Guardian/ Adult Participant can understand the consent process and is willing to provide informed consent/HIPAA:
• (a) Participant is receiving one or more of the study drugs of interest at the time of enrollment or (b) Participant is NOT receiving one or more of the study drugs of interest but is SARS-COV-2 positive within 60 days prior to enrollment
Exclusion Criteria:
• Participant has a known pregnancy Below exclusion criteria apply only to participants receiving one or more of the study drugs of interest at the time of enrollment,
• Has had intermittent dialysis within previous 24 hours
• Has had a kidney transplant within previous 30 days
• Has had a liver transplant within previous 1 year
• Has had a stem cell transplant within previous 1 year
• Has had therapeutic hypothermia within previous 24 hours
• Has had plasmapheresis within the previous 24 hours
• Has a Ventricular Assist Device
• Has any condition which would make the participant, in the opinion of the investigator, unsuitable for the study
Drug: The POP02 study is collecting bodily fluid samples (i.e., whole blood, effluent samples) of children prescribed the following drugs of interest per standard of care:
Coronavirus Infection (COVID-19), Pulmonary Arterial Hypertension, Urinary Tract Infections in Children, Hypertension, Pain, Hyperphosphatemia, Primary Hyperaldosteronism, Edema, Hypokalemia, Heart Failure, Hemophilia, Menorrhagia, Insomnia, Pneumonia, Skin Infection, Arrythmia, Asthma in Children, Bronchopulmonary Dysplasia, Adrenal Insufficiency, Fibrinolysis, Hemorrhage, Attention Deficit Hyperactivity Disorder, Multisystem Inflammatory Syndrome in Children (MIS-C), Kawasaki Disease, Coagulation Disorder, Down Syndrome
Investigation of Persistent HIV Immune Stimulation in Lymphoid Tissues During Therapy as a Cause of Sustained Immune Activation
Timothy Schacker
18 Years and over
NA
IDIM-2020-28516
STUDY00009216
Inclusion Criteria:
• Age >/= 18 years of age
• HIV infection
• Receiving an ART regimen
• Able to provide written voluntary consent before performance of any study related procedure.
Exclusion Criteria:
• BMI >/= 30
• Currently taking anticoagulant blood thinners such as warfarin, enoxaparin, heparin
• Pregnant or breastfeeding
• Adults lacking capacity to consent and/or adults with diminished capacity to consent, including, but not limited to, those with acute medical conditions, psychiatric disorders, neurologic disorders, developmental disorders, and behavioral disorders.
• More than 3 pervious lymph node biopsies for the main study. No more than 2 lymph nodes for the sub-study.
Infectious Diseases
HIV, immune activation, immune response