Phase
Condition
Chronic Fatigue Syndrome
Lyme Disease
Muscle Pain
Treatment
Lumbrokinase
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Any gender
Aged 18+
Baseline EQ-VAS ≤70; EQ-VAS before the index infection ≥80 (this information iscollected as part of the baseline survey).
Diagnosed with only one of the following conditions:
Long Covid
Documented clinical history of confirmed or suspected acute COVID-19 infection aminimum of 3 months prior to contact with the study team
Formal diagnosis of Long Covid from a physician
Post-treatment Lyme disease syndrome
Diagnosis will be based on participants meeting either Group 1 or Group 2 criteriaof the Columbia Clinical Trial Network PTLDS diagnostic criteria:
Group 1. Well-defined Lyme disease meeting CDC Surveillance Definition ErythemaMigrans History of possible exposure to a high incidence county or state (or anadjacent area) Erythema migrans rash
EM 1: EM rash diagnosed by HCP previously (either in person ortelemedicine)
EM 1A: MOA self-report & medical record documentation of rash > 5 cm
EM 1B: MOA: self-report and medical record documentation of EM rash butnot size
EM 1C: MOA: self-report & rash misdiagnosed in medical record ascellulitis/spider bite
EM 1D: MOA: self-report and either: photo of EM or Class 1 lab testconfirmation within 4 weeks of illness onset OR
Disseminated "objective" manifestation with lab test confirmation of Bbinfection
Clinical history includes at least one of the following symptoms/signs,which are not better accounted for by another cause (MOA: medical recordsand/or self-report).
Neurologic: Lymphocytic Meningitis ; Encephalitis; EncephalomyelitisCranial Neuritis (especially facial palsy); Radiculoneuropathy; OtherNeurologic Signs (with objective measures) : Encephalopathy,Polyneuropathy
Carditis: 2nd or 3rd degree AV block; Myocarditis; Pericarditis
Lyme arthritis: Recurrent joint swelling in one or more joints
Dermatologic: Disseminated EM ("satellite") or Acrodermatitis atrophicansAND
Lab test Confirmation (requires at least one of the Class 1 lab tests) (MOA: self-report & documentation)
Group 2. Probable
2A. Chronic Multisystem Symptoms attributed to Lyme disease (insufficientto meet Group 1) and not better explained by another diagnosis and patienthas evidence of positive lab results on a Class 1 lab test (or 4 of 10bands for IgG Western blot (WB)) (MOA: self-report with lab documentationClass 1 lab test confirmation (excluding IgM WB) Highly suggestive IgG WB (4 of 10 bands) OR
2B. EM rash by history after exposure to a Lyme-endemic area but notpreviously diagnosed by a HCP and no photo or Class 1 lab testconfirmation is available (MOA: self-report) OR
2C. Viral like illness (not better explained by other cause) withindeterminate or + enzyme immunoassay (EIA) with positive IgM WB orpositive Class 1 lab test (within 4 weeks of illness onset after knownexposure to a Lyme high-incidence area for standard two-tiered (STT) IgM) (MOA: medical records, lab test and self-report) (MOA: lab test andself-report) OR
2D. Viral like illness (not better explained by other cause) withindeterminate or positive EIA with positive IgM WB or positive Class 1 labtest (within 6 months of illness onset after known exposure to a Lymehigh-incidence area for standard two-tiered (STT) IgM)
(MOA: medical records, lab test and self-report)
(MOA: lab test and self-report)
ME/CFS
Formal diagnosis of ME/CFS prior to 2020 from a physician
Actively symptomatic such that the 2011 International Criteria for ME/CFS is met attime of screening
Exclusion
Exclusion Criteria:
Current use of antiplatelet or anticoagulation regimen
Diagnosis of an autoimmune condition such as Chronic EBV, Multiple Sclerosis,Hashimoto's Disease, etc. which would impact the immunological profiling analysis.
Pregnancy or lactation
Known allergy to earthworms (Lumbrokinase is a supplement that is derived fromearthworms)
Past medical history of a bleeding or clotting disorder
Has a scheduled surgery during, or immediately after, the study period
Study Design
Connect with a study center
The Cohen Center for Recovery from Complex Chronic Illnesses (CoRE)
New York, New York 10029
United StatesActive - Recruiting
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