Nctid:
NCT06223971
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000094024", "term"=>"Post-Acute COVID-19 Syndrome"}], "ancestors"=>[{"id"=>"D000086382", "term"=>"COVID-19"}, {"id"=>"D000011024", "term"=>"Pneumonia, Viral"}, {"id"=>"D000011014", "term"=>"Pneumonia"}, {"id"=>"D000012141", "term"=>"Respiratory Tract Infections"}, {"id"=>"D000007239", "term"=>"Infections"}, {"id"=>"D000014777", "term"=>"Virus Diseases"}, {"id"=>"D000018352", "term"=>"Coronavirus Infections"}, {"id"=>"D000003333", "term"=>"Coronaviridae Infections"}, {"id"=>"D000030341", "term"=>"Nidovirales Infections"}, {"id"=>"D000012327", "term"=>"RNA Virus Infections"}, {"id"=>"D000008171", "term"=>"Lung Diseases"}, {"id"=>"D000012140", "term"=>"Respiratory Tract Diseases"}, {"id"=>"D000094025", "term"=>"Post-Infectious Disorders"}, {"id"=>"D000002908", "term"=>"Chronic Disease"}, {"id"=>"D000020969", "term"=>"Disease Attributes"}, {"id"=>"D000010335", "term"=>"Pathologic Processes"}], "browseLeaves"=>[{"id"=>"M2561", "name"=>"COVID-19", "relevance"=>"LOW"}, {"id"=>"M3013", "name"=>"Post-Acute COVID-19 Syndrome", "asFound"=>"Long COVID", "relevance"=>"HIGH"}, {"id"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"id"=>"M13904", "name"=>"Pneumonia", "relevance"=>"LOW"}, {"id"=>"M13914", "name"=>"Pneumonia, Viral", "relevance"=>"LOW"}, {"id"=>"M10283", "name"=>"Infections", "relevance"=>"LOW"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M14978", "name"=>"Respiratory Tract Infections", "relevance"=>"LOW"}, {"id"=>"M17522", "name"=>"Virus Diseases", "relevance"=>"LOW"}, {"id"=>"M20490", "name"=>"Coronavirus Infections", "relevance"=>"LOW"}, {"id"=>"M6555", "name"=>"Coronaviridae Infections", "relevance"=>"LOW"}, {"id"=>"M23685", "name"=>"Nidovirales Infections", "relevance"=>"LOW"}, {"id"=>"M15149", "name"=>"RNA Virus Infections", "relevance"=>"LOW"}, {"id"=>"M11168", "name"=>"Lung Diseases", "relevance"=>"LOW"}, {"id"=>"M14977", "name"=>"Respiratory Tract Diseases", "relevance"=>"LOW"}, {"id"=>"M3014", "name"=>"Post-Infectious Disorders", "relevance"=>"LOW"}, {"id"=>"M6147", "name"=>"Chronic Disease", "relevance"=>"LOW"}, {"id"=>"M22700", "name"=>"Disease Attributes", "relevance"=>"LOW"}, {"id"=>"T170", "name"=>"Acute Graft Versus Host Disease", "relevance"=>"LOW"}, {"id"=>"T1303", "name"=>"Chronic Graft Versus Host Disease", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"Respiratory Tract (Lung and Bronchial) Diseases", "abbrev"=>"BC08"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["EARLY_PHASE1"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NON_RANDOMIZED", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"DIAGNOSTIC", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>6}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-08-06", "type"=>"ACTUAL"}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2024-10-30", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-11", "studyFirstSubmitDate"=>"2024-01-23", "studyFirstSubmitQcDate"=>"2024-01-23", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-19", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-25", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-10-30", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"To assess the safety and tolerability of one dose level of [11C]CPPC when administered intravenously.", "timeFrame"=>"Baseline and up to 2 days follow-up after scan", "description"=>"Safety and tolerability will be determined by evaluation of spontaneously reported adverse events, clinical laboratory test results, physical, cognitive and neurologic exams and imaging (PET)."}, {"measure"=>"Safety of use of [11C]CPPC in patients with Long-COVID and healthy participants with history of COVID-19 infection as assessed by a change in complete blood count (CBC) test.", "timeFrame"=>"Baseline and up to 2 days follow-up after scan", "description"=>"Safety of use of \\[11C\\]CPPC in positron emission tomography (PET) neuroimaging of patients with Long-Covid and healthy participants with history of COVID-19 infection. Safety will be assessed by monitoring of the complete blood count (CBC) for a change from baseline that is outside of the normal range."}, {"measure"=>"Safety of use of [11C]CPPC in patients with Long-COVID and healthy participants with history of COVID-19 infection as assessed by a change in complete metabolic panel (CMP) test.", "timeFrame"=>"Baseline and up to 2 days follow-up after scan", "description"=>"Safety of use of \\[11C\\]CPPC in positron emission tomography (PET) neuroimaging of patients with Long-COVID and healthy participants with history of COVID-19 infection. Safety will be assessed by a change in the CMP from baseline that is outside of the normal range"}], "secondaryOutcomes"=>[{"measure"=>"Biodistribution of [11C]CPPC by PET imaging", "timeFrame"=>"1 day", "description"=>"Image analysis of PET imaging obtained of patients and healthy participants. The PET compartmental model fits will be applied to the regional time activity curves (TACs) will be first assessed visually before the relative goodness of fit will be assessed using the statistical F test."}, {"measure"=>"Cognitive function as assessed by the NIH Toolbox Cognition Battery (NIHTB-CB)", "timeFrame"=>"1 day", "description"=>"NIH Toolbox Cognition Battery (NIHTB-CB), which is an iPad-based instrument assessing five cognitive sub-domains: Language, Executive Function, Episodic Memory, Processing Speed, and Working Memory. Score range 59 - 140, higher score means better cognition."}, {"measure"=>"Neuro-psychological assessment as assessed by the The Rey-Osterrieth complex figure test (ROCF)", "timeFrame"=>"1 day", "description"=>"The Rey-Osterrieth complex figure test (ROCF) is a neuro-psychological assessment in which participants are asked to reproduce a complicated line drawing, first by copying it freehand (recognition), and then drawing from memory (recall). Scoring of drawings is based on the 36-point scoring system (0 being the worst score and 36 the best)."}, {"measure"=>"Global cognitive function as assessed by the Mini-Mental State Exam (MMSE)", "timeFrame"=>"1 day", "description"=>"The MMSE is a measure of global cognitive function, scores range from 0-30, a lower score indicates greater cognitive impairment."}, {"measure"=>"Dementia as assessed by the Clinical Dementia Rating (CDR) scale", "timeFrame"=>"1 day", "description"=>"The Clinical Dementia Rating Dementia Staging Instrument minimum score = 0, maximum score = 18. Low scores indicate less problems."}, {"measure"=>"Hospital Anxiety and Depression Scale (HADS) score", "timeFrame"=>"1 day", "description"=>"Scoring for the Hospital Anxiety and Depression scale is 0-21; Normal (0-7); Borderline Abnormal Case (8-10); and Abnormal Case (11-21) higher score indicates worse outcome."}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>true, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["COVID Long-Haul"]}, "descriptionModule"=>{"briefSummary"=>"The goal of this study is to evaluate the safety of using the \\[5-cyano-N-(4-(4-\\[11C\\]Methylpiperazin-1-yl)-2-(Piperidin-1-yl)Phenyl)Furan-2-carboxamide\\] (\\[11C\\]CPPC) radiotracer in positron emission tomography (PET) imaging of people with history of COVID-19 infection, with and without symptoms. The investigators are also interested to see whether use of this radiotracer reveals imaging differences between patients with history of COVID-19 infection and still exhibiting symptoms or healthy patients with history of COVID-19 infection but exhibiting no current symptoms.", "detailedDescription"=>"This is a Phase 1 study of safety and tolerability of an investigational radiotracer drug called \\[5-cyano-N-(4-(4-\\[11C\\]Methylpiperazin-1-yl)-2-(Piperidin-1-yl)Phenyl)Furan-2-carboxamide\\] (\\[11C\\]CPPC). A radiotracer is a substance that chemically marks certain structures in the body. In this case, \\[11C\\]CPPC highlights structures expressing colony stimulating factor receptor (CSF1R), a receptor that is expressed on microglial cells. A safety and tolerability study is looking to see if there are any unanticipated, possibly harmful, effects of the use of the radiotracer in humans. However, ultimately, the investigators would like to know if this drug can be used to make better images of the brain for patients with history of COVID-19 infection, which could help doctors better understand the disease and help take care of patients suffering from Long COVID symptoms. This study will use a radiotracer to look for a chemical receptor which may be affected in patients who report of Long COVID. After receiving the radiotracer, participants' brains will be scanned with a positron emission tomography (PET) imaging machine. Each participant will also undergo magnetic resonance imaging (MRI) without contrast, detailed cognitive testing and a neurological exam. This study will assess possible associations between COVID-19 infection, cognitive function, other neurological symptoms, and 11C-CPPC PET neuroimaging in subjects."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n1. Have the ability to understand the requirements of the study, provide written informed consent, understand and provide written authorization for the use and disclosure of Protected Health Information (PHI) \\[per Health Insurance Portability and Accountability Act (HIPAA) Privacy Ruling\\] and comply with the study procedures.\n2. Documented history of COVID infection at least 6 - 12 months before enrollment.\n3. Men and women at least 18 years old.\n4. Women must have a negative serum pregnancy test and practice an acceptable method of contraception or be of non-childbearing potential (post-menopausal for at least 2 years or who have undergone hysterectomy, oophorectomy or surgical sterilization).\n5. Geographic accessibility to the study center and the ability to travel to the clinic for study visits.\n6. Agrees to the visit schedule as outlined in the informed consent.\n7. Pre-study labs within normal range, or if abnormal, deemed not clinically significant by the site investigator.\n\nExclusion Criteria:\n\n1. History of recent nosocomial infection.\n2. History of chronic neurological disorder, such as epilepsy, or structural Central Nervous System (CNS) abnormality such as stroke or arteriovenous malformation.\n3. History of head trauma with prolonged loss of consciousness (\\>10 minutes) or any neurological condition including stroke, seizure (excluding childhood febrile seizure), or visible structural abnormality on prior MRI.\n4. Active or recent (in the past year) substance dependence (drugs-including nicotine, marijuana or alcohol).\n5. Receipt of any investigational drug, device or biologic within 30 days of administration of study compound.\n6. Use of anti-inflammatory medications, immunosuppressants, or benzodiazepines within 7 days of administration of study compound.\n7. Any concomitant medical disease or condition limiting the safety to participate including, but not limited to:\n\n * Coagulopathy\n * Active infection\n8. Contraindications to MRI scanning to include pacemakers, metallic implants/prosthesis or prohibitive claustrophobia, etc.\n9. Contraindications to PET scanning to include pregnancy, etc.\n10. Any medical condition that in the opinion of the study investigators would constitute a safety risk to the subject.\n11. Any radiation exposure in the past calendar year that in combination with the radiation exposure from this study would exceed 5 rem.\n12. Any history of learning disability or special education (due to the potential to affect performance on neuropsychological testing)."}, "identificationModule"=>{"nctId"=>"NCT06223971", "briefTitle"=>"Long COVID-19 [11C]CPPC Study", "organization"=>{"class"=>"OTHER", "fullName"=>"Johns Hopkins University"}, "officialTitle"=>"A Phase l Study to Assess the Safety and Tolerability of PET Imaging With [11 C]CPPC [5-cyano-N-( 4-( 4-[l l CJ me1hylpiperazin-l-yl)-2-(Piperidin-l-yl)Phenyl)Furan-2-carboxamide] Radioligand and Magnetic Resonance (MR) Imaging in Patients With Long COVID.", "orgStudyIdInfo"=>{"id"=>"IRB00361674"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Patients with history of COVID-19 infection and still experiencing symptoms (Long-COVID)", "description"=>"Participants with a diagnosis of Long- COVID will receive a single dose of \\[11C\\]CPPC (370 megabecquerel (MBq) (X±1 mCi)) intravenously and subsequent positron emission tomography (PET) scan.", "interventionNames"=>["Drug: [11C]CPPC Injection"]}, {"type"=>"EXPERIMENTAL", "label"=>"Healthy Participants with history of COVID-19 infection but not experiencing any symptoms.", "description"=>"Healthy participants (without any history of post-COVID symptoms) will receive a single dose of \\[11C\\]CPPC (370 megabecquerel (MBq) (X±1 mCi)) intravenously and subsequent positron emission tomography (PET) scan.", "interventionNames"=>["Drug: [11C]CPPC Injection"]}], "interventions"=>[{"name"=>"[11C]CPPC Injection", "type"=>"DRUG", "description"=>"A single dose of \\[11C\\]CPPC (370 megabecquerel (MBq) (X±1 mCi)) intravenously and subsequent positron emission tomography (PET) scan.\n\nOther Name: \\[5-cyano-N-(4-(4-\\[11C\\]methylpiperazin-1-yl)-2-(piperidin-1-yl)phenyl)furan-2-carboxamide\\]", "armGroupLabels"=>["Patients with history of COVID-19 infection and still experiencing symptoms (Long-COVID)"]}, {"name"=>"[11C]CPPC Injection", "type"=>"DRUG", "description"=>"A single dose of \\[11C\\]CPPC (370 megabecquerel (MBq) (X±1 mCi)) intravenously and subsequent positron emission tomography (PET) scan.\n\nOther Name: \\[5-cyano-N-(4-(4-\\[11C\\]methylpiperazin-1-yl)-2-(piperidin-1-yl)phenyl)furan-2-carboxamide\\]", "armGroupLabels"=>["Healthy Participants with history of COVID-19 infection but not experiencing any symptoms."]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"21287", "city"=>"Baltimore", "state"=>"Maryland", "status"=>"RECRUITING", "country"=>"United States", "contacts"=>[{"name"=>"Mehreen Nabi, MBBS", "role"=>"CONTACT"}, {"name"=>"Licia Luna, M.D., Ph.D.", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"Johns Hopkins Outpatient Center", "geoPoint"=>{"lat"=>39.29038, "lon"=>-76.61219}}], "centralContacts"=>[{"name"=>"Mehreen Nabi, MBBS", "role"=>"CONTACT", "email"=>"mnabi1@jh.edu", "phone"=>"4109296586"}], "overallOfficials"=>[{"name"=>"Licia Luna, M.D., Ph.D.", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Johns Hopkins University"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Johns Hopkins University", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"Radiological Society of North America", "class"=>"OTHER"}], "responsibleParty"=>{"type"=>"SPONSOR"}}}}
