Lumbrokinase for Long Covid Clinical Trial

Purpose

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)

Conditions

  • Long Covid
  • Post-treatment Lyme Disease Syndrome
  • Chronic Fatigue Syndrome
  • Myalgic Encephalomyelitis

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Long Covid 		Boluoke® brand lumbrokinase capsules, 300,000 functional units (FUs) twice per day, daily for 6 weeks.
  • Dietary Supplement: Lumbrokinase
    Boluoke® brand lumbrokinase capsules will be taken daily for 6 weeks.
    Other names:
    • Boluoke® Lumbrokinase
Experimental
Post-treatment Lyme Disease Syndrome 		Boluoke® brand lumbrokinase capsules, 300,000 functional units (FUs) twice per day, daily for 6 weeks.
  • Dietary Supplement: Lumbrokinase
    Boluoke® brand lumbrokinase capsules will be taken daily for 6 weeks.
    Other names:
    • Boluoke® Lumbrokinase
Experimental
ME/CFS 		Boluoke® brand lumbrokinase capsules, 300,000 functional units (FUs) twice per day, daily for 6 weeks.
  • Dietary Supplement: Lumbrokinase
    Boluoke® brand lumbrokinase capsules will be taken daily for 6 weeks.
    Other names:
    • Boluoke® Lumbrokinase

Recruiting Locations

More Details

NCT ID
NCT06511050
Status
Not yet recruiting
Sponsor
Icahn School of Medicine at Mount Sinai

Study Contact

David Putrino, PhD, PT
212-241-8454
CoreResearch@mountsinai.org