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

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
New York
The Cohen Center for Recovery from Complex Chronic Illnesses (CoRE)
RECRUITING
New York
Contact Information
Primary
David Putrino, PhD, PT
CoreResearch@mountsinai.org
212-241-8454
Backup
Mackenzie Doerstling, MPH
CoreResearch@mountsinai.org
212-241-8454
Time Frame
Start Date: 2024-10-09
Estimated Completion Date: 2026-02
Participants
Target number of participants: 120
Treatments
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: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
Boluoke® brand lumbrokinase capsules, 300,000 functional units (FUs) twice per day, daily for 6 weeks.
Sponsors
Collaborators: Columbia University, PolyBio Research Foundation
Leads: Icahn School of Medicine at Mount Sinai

This content was sourced from clinicaltrials.gov