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

Study 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)

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06511050
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Icahn School of Medicine at Mount Sinai
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

David Putrino, PhD, PT
Principal Investigator Affiliation Icahn School of Medicine at Mount Sinai
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Long Covid, Post-treatment Lyme Disease Syndrome, Chronic Fatigue Syndrome, Myalgic Encephalomyelitis
Arms & Interventions

Arms

Experimental: Long Covid

Boluoke® brand lumbrokinase capsules, 300,000 functional units (FUs) twice per day, daily for 6 weeks.

Experimental: Post-treatment Lyme Disease Syndrome

Boluoke® brand lumbrokinase capsules, 300,000 functional units (FUs) twice per day, daily for 6 weeks.

Experimental: ME/CFS

Boluoke® brand lumbrokinase capsules, 300,000 functional units (FUs) twice per day, daily for 6 weeks.

Interventions

Dietary Supplement: - Lumbrokinase

Boluoke® brand lumbrokinase capsules will be taken daily for 6 weeks.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

New York, New York

Status

Recruiting

Address

The Cohen Center for Recovery from Complex Chronic Illnesses (CoRE)

New York, New York, 10029

Site Contact

Mackenzie Doerstling, MPH

[email protected]

212-241-8454