๐ฌIn plain words
What the trial is, and whether it could suit you
This will be a pilot multi-arm clinical trial investigating the feasibility of Lumbrokinase (LK) as an intervention in three clinical cohorts:
* Long Covid (LC)
* Post-treatment Lyme disease syndrome (PTLDS)
* Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS)
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
* Any gender
* Aged 18+
* Baseline EQ-VAS โค70; EQ-VAS before the index infection โฅ80 (this information is collected 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 a minimum 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 criteria of the Columbia Clinical Trial Network PTLDS diagnostic criteria:
* 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
* EM 1: EM rash diagnosed by HCP previously (either in person or telemedicine)
* EM 1A: MOA self-report \& medical record documentation of rash \> 5 cm
* EM 1B: MOA: self-report and medical record documentation of EM rash but not size
* EM 1C: MOA: self-report \& rash misdiagnosed in medical record as cellulitis/spider bite
* EM 1D: MOA: self-report and either: photo of EM or Class 1 lab test confirmation within 4 weeks of illness onset OR
* Disseminated "objective" manifestation with lab test confirmation of Bb infection
* Clinical history includes at least one of the following symptoms/signs, which are not better accounted for by another cause (MOA: medical records and/or self-report).
* Neurologic: Lymphocytic Meningitis ; Encephalitis; Encephalomyelitis Cranial Neuritis (especially facial palsy); Radiculoneuropathy; Other Neurologic 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 atrophicans AND
* 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 (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
* 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
* 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
* 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)
* (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 at time of screening
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 from earthworms)
* Past medical history of a bleeding or clotting disorder
* Has a scheduled surgery during, or immediately after, the study period
The Cohen Center for Recovery from Complex Chronic Illnesses (CoRE)
New York, United States
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.