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

Launched by ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · Jul 16, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a treatment called Lumbrokinase (LK) for adults suffering from Long Covid, Post-treatment Lyme Disease Syndrome, and Myalgic Encephalomyelitis/Chronic Fatigue Syndrome. The goal of the study is to see if Lumbrokinase is a feasible option to help these patients feel better. To participate, individuals must be at least 18 years old and diagnosed with one of the three conditions. They should also have had some limitations in their daily activities due to their symptoms.

Participants in the trial will undergo assessments to determine their eligibility and will receive Lumbrokinase as part of the study. This is a pilot trial, meaning it’s an early stage of research to explore how well this treatment works and how safe it is. It's important to note that people currently taking blood-thinning medications, pregnant or breastfeeding women, and those with certain medical conditions may not qualify for the study. If you or someone you know is interested in participating, please reach out for more information!

Gender

ALL

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