Tests lumbrokinase in adults with Long Covid, Lyme aftereffects, or ME/CFS
Tests a supplement, lumbrokinase, in adults with long-lasting Covid, Lyme or ME/CFS symptoms.
Plain-language title generated from the registry record
Registry title: Lumbrokinase for Adults With Long Covid, Post-treatment Lyme Disease Syndrome, and Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
Key facts
- Where
- New York, United StatesSee the site
- Phase
- Phase 1/2
Where in United States
- The Cohen Center for Recovery from Complex Chronic Illnesses (CoRE)New York, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Icahn School of Medicine at Mount Sinai
- Trial code
- NCT06511050
- Record updated
- 13 March 2026
- Original description
This will be a pilot multi-arm clinical trial investigating the feasibility of Lumbrokinase (LK) as an intervention in three clinical cohorts:Read full original descriptionShow less
Investigating the Effects of Lumbrokinase in Adults With Long Covid, Post-treatment Lyme Disease Syndrome, and Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
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)
Inclusion: Any gender; Aged 18+; Baseline EQ-VAS ≤70; EQ-VAS before the index infection ≥80 (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: Has a scheduled surgery during, or immediately after, the study period; Diagnosis of an autoimmune condition such as Chronic EBV, Multiple Sclerosis, Hashimoto's Disease, etc. which would impact the immunological profiling analysis; Known allergy to earthworms (Lumbrokinase is a supplement that is derived from earthworms); Past medical history of a bleeding or clotting disorder; Current use of antiplatelet or anticoagulation regimen; Pregnancy or lactation.