Lumbrokinase for Long Covid, Post-treatment Lyme Disease Syndrome, and ME/CFS
This study is looking at whether a dietary supplement called Lumbrokinase (Boluoke® brand) can help adults with Long Covid, Post-treatment Lyme Disease Syndrome (PTLDS), or Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). Researchers want to see if taking Lumbrokinase capsules daily for 6 weeks is a practical treatment. You might be able to join if you are 18 or older and have one of these conditions, with a specific score on a health questionnaire (EQ-VAS). The main goal is to see how your overall health and quality of life, measured by the EuroQol Visual Analogue Scale (EQ-VAS), changes over 12 weeks. The study plans to enroll 120 participants, but its current recruitment status is unclear.
- Study design
- This is an interventional pilot study, meaning participants will receive a specific treatment. It aims to enroll 120 participants across three different health conditions.
- What's involved
- Participants will take Lumbrokinase capsules daily for 6 weeks. The study will measure health and quality of life up to 12 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for changes in their health and quality of life for up to 12 weeks after starting the intervention.
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NCT06511050
Lumbrokinase for Adults With Long Covid, Post-treatment Lyme Disease Syndrome, and Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
Recruiting
PHASE1Ages 18+InterventionalTreatmentIcahn School of Medicine at Mount SinaiInvestigator-initiated
~120 participants
Updated 2026-03-13 on ClinicalTrials.gov
What's tested:Lumbrokinase
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
EuroQol Visual Analogue Scale Score (EQ-VAS)
Measured over Up to 12 weeks
Conditions
Where it's being run
1 sites across 1 statesNew York1
Study leadership
- David Putrino, PhD, PT · PRINCIPAL_INVESTIGATOR · Icahn School of Medicine at Mount Sinai
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
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
What this trial measures
- EuroQol Visual Analogue Scale Score (EQ-VAS)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.