Status:
RECRUITING
Lumbrokinase for Adults With Long Covid, Post-treatment Lyme Disease Syndrome, and Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Collaborating Sponsors:
Columbia University
PolyBio Research Foundation
Conditions:
Long Covid
Post-treatment Lyme Disease Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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...
Eligibility Criteria
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
- 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
Key Trial Info
Start Date :
October 9 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06511050
Start Date
October 9 2024
End Date
February 1 2026
Last Update
May 14 2025
Active Locations (1)
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1
The Cohen Center for Recovery from Complex Chronic Illnesses (CoRE)
New York, New York, United States, 10029