Clinical trial NCT06511050: Lumbrokinase for Adults With Long Covid, Post-treatment Lyme Disease Syndrome, and Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
Official title: Investigating the Effects of Lumbrokinase in Adults With Long Covid, Post-treatment Lyme Disease Syndrome, and Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Long Covid
Post-treatment Lyme Disease Syndrome
Chronic Fatigue Syndrome
Myalgic Encephalomyelitis
Keywords: Long Covid
Lyme Disease
ME/CFS
Lumbrokinase
Post-treatment Lyme disease syndrome
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: Columbia University
name: PolyBio Research Foundation
First posted: 2024-07-19
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)


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

Primary outcomes:
measure: EuroQol Visual Analogue Scale Score (EQ-VAS)
timeFrame: Up to 12 weeks
Secondary outcomes:
measure: The EuroQol Five-Dimensional Health Questionnaire (EQ-5D-5L)
timeFrame: Up to 12 weeks
measure: 10-Meter Walk Test
timeFrame: Up to 12 weeks
measure: Root mean square of successive differences between normal heartbeats (RMSSD)
timeFrame: Up to 12 weeks
measure: BrainCheck Cognitive Assessment Battery
timeFrame: Up to 12 weeks
measure: General Symptom Questionnaire (GSQ-30)
timeFrame: Up to 12 weeks
measure: Medical Research Council Breathlessness Scale (MRC)
timeFrame: Up to 12 weeks
measure: Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS)
timeFrame: Up to 12 weeks
measure: Patient Health Questionnaire (PHQ-2)
timeFrame: Up to 12 weeks
measure: Generalized Anxiety Disorder (GAD-7)
timeFrame: Up to 12 weeks
measure: Neuro-QoL™ v2.0 Cognitive Function-Short Form
timeFrame: Up to 12 weeks
measure: Fatigue Severity Scale
timeFrame: Up to 12 weeks
measure: DePaul Post-Exertional Malaise Questionnaire (DSQ)
timeFrame: Up to 12 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: The Cohen Center for Recovery from Complex Chronic Illnesses (CoRE)
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: David Putrino, PhD, PT
role: PRINCIPAL_INVESTIGATOR
References: