Lumbrokinase for Adults With Long Covid, Post-treatment Lyme Disease Syndrome, and Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

Last updated: May 10, 2025
Sponsor: Icahn School of Medicine at Mount Sinai
Overall Status: Active - Recruiting

Phase

1/2

Condition

Chronic Fatigue Syndrome

Lyme Disease

Muscle Pain

Treatment

Lumbrokinase

Clinical Study ID

NCT06511050
STUDY-24-00154
  • Ages > 18
  • All Genders

Study Summary

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)

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

Total Participants: 120
Treatment Group(s): 1
Primary Treatment: Lumbrokinase
Phase: 1/2
Study Start date:
October 09, 2024
Estimated Completion Date:
February 28, 2026

Connect with a study center

  • The Cohen Center for Recovery from Complex Chronic Illnesses (CoRE)

    New York, New York 10029
    United States

    Active - Recruiting

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