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

Mount Sinai Health System

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Myalgic Encephalomyelitis; Long Covid; Post-treatment Lyme Disease Syndrome; Chronic Fatigue Syndrome

Treatments: Dietary Supplement: Lumbrokinase

Study type: Interventional

Funder types: Other

Identifiers

NCT06511050

STUDY-24-00154

Details and patient eligibility

About

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)

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 3 patient groups

Long Covid

Experimental group

Description:

Boluoke® brand lumbrokinase capsules, 300,000 functional units (FUs) twice per day, daily for 6 weeks.

Treatment:

Dietary Supplement: Lumbrokinase

Post-treatment Lyme Disease Syndrome

Experimental group

Description:

Boluoke® brand lumbrokinase capsules, 300,000 functional units (FUs) twice per day, daily for 6 weeks.

Treatment:

Dietary Supplement: Lumbrokinase

ME/CFS

Experimental group

Description:

Boluoke® brand lumbrokinase capsules, 300,000 functional units (FUs) twice per day, daily for 6 weeks.

Treatment:

Dietary Supplement: Lumbrokinase