[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100555358":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":28,"centralContacts":32,"locations":40,"responsibleParty":58,"collaborators":60,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":36,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":36,"enrollmentInfo":74,"targetDuration":36,"studyType":77,"phases":78,"briefSummary":81,"conditions":82,"keywords":85,"overallStatus":43,"whyStopped":36,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Icahn School of Medicine at Mount Sinai","OTHER",[8,14,17],{"label":9,"type":10,"description":11,"interventionNames":12},"Long Covid","EXPERIMENTAL","Boluoke® brand lumbrokinase capsules, 300,000 functional units (FUs) twice per day, daily for 6 weeks.",[13],"Dietary Supplement: Lumbrokinase",{"label":15,"type":10,"description":11,"interventionNames":16},"Post-treatment Lyme Disease Syndrome",[13],{"label":18,"type":10,"description":11,"interventionNames":19},"Myalgic Encephalomyelitis\u002FChronic Fatigue Syndrome",[13],[21],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIETARY_SUPPLEMENT","Lumbrokinase","Boluoke® brand lumbrokinase capsules will be taken daily for 6 weeks.",[9,18,15],[27],"Boluoke® Lumbrokinase",[29],{"name":30,"affiliation":5,"role":31},"David Putrino, PhD, PT","PRINCIPAL_INVESTIGATOR",[33,38],{"name":30,"role":34,"phone":35,"phoneExt":36,"email":37},"CONTACT","212-241-8454",null,"CoreResearch@mountsinai.org",{"name":39,"role":34,"phone":35,"phoneExt":36,"email":37},"Mackenzie Doerstling, MPH",[41],{"facility":42,"status":43,"city":44,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"The Cohen Center for Recovery from Complex Chronic Illnesses (CoRE)","RECRUITING","New York","10029","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-74.00597,40.71427,{"lat":52,"lon":51},[55,56],{"name":39,"role":34,"phone":36,"phoneExt":36,"email":37},{"name":57,"role":31,"phone":36,"phoneExt":36,"email":36},"David Putrino",{"type":31,"investigatorFullName":57,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":36,"oldOrganization":36},"Professor",[61,63],{"name":62,"class":6},"Columbia University",{"name":64,"class":6},"PolyBio Research Foundation","100555358","phase-1-lumbrokinase-for-adults-with-long-covid-post-treatment-lyme-disease-syndrome-and-myalgic-encephalomyelitischronic-fatigue-syndrome-100555358",false,"NCT06511050","Lumbrokinase for Adults With Long Covid, Post-treatment Lyme Disease Syndrome, and Myalgic Encephalomyelitis\u002FChronic Fatigue Syndrome","Investigating the Effects of Lumbrokinase in Adults With Long Covid, Post-treatment Lyme Disease Syndrome, and Myalgic Encephalomyelitis\u002FChronic Fatigue Syndrome","Inclusion Criteria:\n\n* Any gender\n* Aged 18+\n* Baseline EQ-VAS ≤70; EQ-VAS before the index infection ≥80 (this information is collected as part of the baseline survey).\n* Diagnosed with only one of the following conditions:\n* Long Covid\n* Documented clinical history of confirmed or suspected acute COVID-19 infection a minimum of 3 months prior to contact with the study team\n* Formal diagnosis of Long Covid from a physician\n* Post-treatment Lyme disease syndrome\n* Diagnosis will be based on participants meeting either Group 1 or Group 2 criteria of the Columbia Clinical Trial Network PTLDS diagnostic criteria:\n\n  * Group 1. Well-defined Lyme disease meeting CDC Surveillance Definition Erythema Migrans History of possible exposure to a high incidence county or state (or an adjacent area) Erythema migrans rash\n\n    * EM 1: EM rash diagnosed by HCP previously (either in person or telemedicine)\n    * EM 1A: MOA self-report \\& medical record documentation of rash \\> 5 cm\n    * EM 1B: MOA: self-report and medical record documentation of EM rash but not size\n    * EM 1C: MOA: self-report \\& rash misdiagnosed in medical record as cellulitis\u002Fspider bite\n    * EM 1D: MOA: self-report and either: photo of EM or Class 1 lab test confirmation within 4 weeks of illness onset OR\n    * Disseminated \"objective\" manifestation with lab test confirmation of Bb infection\n    * Clinical history includes at least one of the following symptoms\u002Fsigns, which are not better accounted for by another cause (MOA: medical records and\u002For self-report).\n    * Neurologic: Lymphocytic Meningitis ; Encephalitis; Encephalomyelitis Cranial Neuritis (especially facial palsy); Radiculoneuropathy; Other Neurologic Signs (with objective measures) : Encephalopathy, Polyneuropathy\n    * Carditis: 2nd or 3rd degree AV block; Myocarditis; Pericarditis\n    * Lyme arthritis: Recurrent joint swelling in one or more joints\n    * Dermatologic: Disseminated EM (\"satellite\") or Acrodermatitis atrophicans AND\n    * Lab test Confirmation (requires at least one of the Class 1 lab tests) (MOA: self-report \\& documentation)\n  * Group 2. Probable\n\n    * 2A. Chronic Multisystem Symptoms attributed to Lyme disease (insufficient to meet Group 1) and not better explained by another diagnosis and patient has evidence of positive lab results on a Class 1 lab test (or 4 of 10 bands for IgG Western blot (WB)) (MOA: self-report with lab documentation Class 1 lab test confirmation (excluding IgM WB) Highly suggestive IgG WB (4 of 10 bands) OR\n    * 2B. EM rash by history after exposure to a Lyme-endemic area but not previously diagnosed by a HCP and no photo or Class 1 lab test confirmation is available (MOA: self-report) OR\n    * 2C. Viral like illness (not better explained by other cause) with indeterminate or + enzyme immunoassay (EIA) with positive IgM WB or positive Class 1 lab test (within 4 weeks of illness onset after known exposure to a Lyme high-incidence area for standard two-tiered (STT) IgM) (MOA: medical records, lab test and self-report) (MOA: lab test and self-report) OR\n    * 2D. Viral like illness (not better explained by other cause) with indeterminate or positive EIA with positive IgM WB or positive Class 1 lab test (within 6 months of illness onset after known exposure to a Lyme high-incidence area for standard two-tiered (STT) IgM)\n* (MOA: medical records, lab test and self-report)\n* (MOA: lab test and self-report)\n* ME\u002FCFS\n* Formal diagnosis of ME\u002FCFS prior to 2020 from a physician\n* Actively symptomatic such that the 2011 International Criteria for ME\u002FCFS is met at time of screening\n\nExclusion Criteria:\n\n* Current use of antiplatelet or anticoagulation regimen\n* Diagnosis of an autoimmune condition such as Chronic EBV, Multiple Sclerosis, Hashimoto's Disease, etc. which would impact the immunological profiling analysis.\n* Pregnancy or lactation\n* Known allergy to earthworms (Lumbrokinase is a supplement that is derived from earthworms)\n* Past medical history of a bleeding or clotting disorder\n* Has a scheduled surgery during, or immediately after, the study period","ALL","18 Years",{"count":75,"type":76},120,"ESTIMATED","INTERVENTIONAL",[79,80],"PHASE1","PHASE2","This will be a pilot multi-arm clinical trial investigating the feasibility of Lumbrokinase (LK) as an intervention in three clinical cohorts:\n\n* Long Covid (LC)\n* Post-treatment Lyme disease syndrome (PTLDS)\n* Myalgic encephalomyelitis\u002Fchronic fatigue syndrome (ME\u002FCFS)",[9,15,83,84],"Chronic Fatigue Syndrome","Myalgic Encephalomyelitis",[9,86,87,23,88],"Lyme Disease","ME\u002FCFS","Post-treatment Lyme disease syndrome","2026-03-11",{"date":91,"type":92},"2026-03-13","ACTUAL",{"date":94,"type":92},"2024-10-09",{"date":96,"type":76},"2026-12",{"name":5,"class":6},1]