Using Lumbrokinase to treat Long Covid, Lyme Disease, and Chronic Fatigue Syndrome

Investigating the Effects of Lumbrokinase in Adults With Long Covid, Post-treatment Lyme Disease Syndrome, and Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

This study is testing if a treatment called Lumbrokinase can help adults with Long Covid, Lyme Disease, and Chronic Fatigue Syndrome feel better and improve their quality of life.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Icahn School of Medicine at Mount Sinai (Academic / other)
• Locations: 1 site (New York, New York)
• Trial ID: NCT06511050 on ClinicalTrials.gov

What this trial studies

This pilot multi-arm clinical trial investigates the feasibility of Lumbrokinase (LK) as a treatment for three specific conditions: Long Covid, Post-treatment Lyme Disease Syndrome, and Myalgic Encephalomyelitis/Chronic Fatigue Syndrome. Participants aged 18 and older, who meet specific diagnostic criteria for these conditions, will receive Lumbrokinase to assess its effectiveness. The study aims to evaluate the potential benefits of LK in improving symptoms and quality of life for affected individuals.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older diagnosed with Long Covid, Post-treatment Lyme Disease Syndrome, or Chronic Fatigue Syndrome.

Not a fit: Patients who do not meet the diagnostic criteria for the specified conditions or have a baseline EQ-VAS score above 70 may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from Long Covid, Lyme Disease, and Chronic Fatigue Syndrome.

How similar studies have performed: While this approach is novel, there is limited existing research on Lumbrokinase for these specific conditions, making this trial an important exploratory effort.

Eligibility criteria

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

Where this trial is running

New York, New York

• The Cohen Center for Recovery from Complex Chronic Illnesses (CoRE) — New York, New York, United States (Recruiting)

Study contacts

• Principal investigator: David Putrino, PhD, PT — Icahn School of Medicine at Mount Sinai
• Study coordinator: David Putrino, PhD, PT

Conditions Long Covid; Post-treatment Lyme Disease Syndrome; Chronic Fatigue Syndrome; Myalgic Encephalomyelitis; Lyme Disease; ME/CFS; Lumbrokinase; Post-treatment Lyme disease syndrome