NCT06511050RecruitingPhase 1
Investigating the Effects of Lumbrokinase in Adults With Long Covid, Post-treatment Lyme Disease Syndrome, and Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
Icahn School of Medicine at Mount Sinai1 site in 1 country120 target enrollmentStarted: October 9, 2024Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- EuroQol Visual Analogue Scale Score (EQ-VAS)
Study Overview
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 (PTLDS)
- Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS)
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Any gender
- •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:
- •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)
- •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)
- •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
Arms & Interventions
Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
Experimental
Boluoke® brand lumbrokinase capsules, 300,000 functional units (FUs) twice per day, daily for 6 weeks.
Intervention: Lumbrokinase (Dietary Supplement)
Long Covid
Experimental
Boluoke® brand lumbrokinase capsules, 300,000 functional units (FUs) twice per day, daily for 6 weeks.
Intervention: Lumbrokinase (Dietary Supplement)
Post-treatment Lyme Disease Syndrome
Experimental
Boluoke® brand lumbrokinase capsules, 300,000 functional units (FUs) twice per day, daily for 6 weeks.
Intervention: Lumbrokinase (Dietary Supplement)
Outcomes
Primary Outcomes
EuroQol Visual Analogue Scale Score (EQ-VAS)
Time Frame: Up to 12 weeks
The EQ VAS is a visual analogue scale that allows individuals to rate their overall health from 0 (worst imaginable health) to 100 (best imaginable health), providing a quantitative measure of health as judged by the patient.
Secondary Outcomes
- BrainCheck Cognitive Assessment Battery(Up to 12 weeks)
- The EuroQol Five-Dimensional Health Questionnaire (EQ-5D-5L)(Up to 12 weeks)
- 10-Meter Walk Test(Up to 12 weeks)
- Root mean square of successive differences between normal heartbeats (RMSSD)(Up to 12 weeks)
- General Symptom Questionnaire (GSQ-30)(Up to 12 weeks)
- Medical Research Council Breathlessness Scale (MRC)(Up to 12 weeks)
- Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS)(Up to 12 weeks)
- Patient Health Questionnaire (PHQ-2)(Up to 12 weeks)
- Generalized Anxiety Disorder (GAD-7)(Up to 12 weeks)
- Neuro-QoL™ v2.0 Cognitive Function-Short Form(Up to 12 weeks)
- Fatigue Severity Scale(Up to 12 weeks)
- DePaul Post-Exertional Malaise Questionnaire (DSQ)(Up to 12 weeks)
Investigators
David Putrino
Professor
Icahn School of Medicine at Mount Sinai
Study Sites (1)
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