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Recruiting NCT06511050

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

Phase I / Phase II Interventional Long Covid Post-treatment Lyme Disease Syndrome Chronic Fatigue Syndrome Myalgic Encephalomyelitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Lumbrokinase.
Who it may be relevant to
Registry conditions: Long Covid, Post-treatment Lyme Disease Syndrome, Chronic Fatigue Syndrome, Myalgic Encephalomyelitis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Investigating the Effects of Lumbrokinase in Adults With Long Covid, Post-treatment Lyme Disease Syndrome, and Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

Overview

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)

Interventions

  • Dietary supplement Lumbrokinase
    Boluoke® brand lumbrokinase capsules will be taken daily for 6 weeks.

Primary outcome measures

  • EuroQol Visual Analogue Scale Score (EQ-VAS) [Time frame: Up to 12 weeks]
Secondary outcome measures (12)
  • The EuroQol Five-Dimensional Health Questionnaire (EQ-5D-5L) [Time frame: Up to 12 weeks]
  • 10-Meter Walk Test [Time frame: Up to 12 weeks]
  • Root mean square of successive differences between normal heartbeats (RMSSD) [Time frame: Up to 12 weeks]
  • BrainCheck Cognitive Assessment Battery [Time frame: Up to 12 weeks]
  • General Symptom Questionnaire (GSQ-30) [Time frame: Up to 12 weeks]
  • Medical Research Council Breathlessness Scale (MRC) [Time frame: Up to 12 weeks]
  • Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS) [Time frame: Up to 12 weeks]
  • Patient Health Questionnaire (PHQ-2) [Time frame: Up to 12 weeks]
  • Generalized Anxiety Disorder (GAD-7) [Time frame: Up to 12 weeks]
  • Neuro-QoL™ v2.0 Cognitive Function-Short Form [Time frame: Up to 12 weeks]
  • Fatigue Severity Scale [Time frame: Up to 12 weeks]
  • DePaul Post-Exertional Malaise Questionnaire (DSQ) [Time frame: Up to 12 weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • The Cohen Center for Recovery from Complex Chronic Illnesses (CoRE) — New York

Identifiers

NCT: NCT06511050 · STUDY-24-00154

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗