RECRUITING

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

Conditions

Long Covid Post-treatment Lyme Disease Syndrome Chronic Fatigue Syndrome Myalgic Encephalomyelitis Lyme Disease ME/CFS Lumbrokinase

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Official Title

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

Quick Facts

Study Start:2024-10-09

Study Completion:2026-02-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06511050

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

David Putrino, PhD, PT

CONTACT

212-241-8454

CoreResearch@mountsinai.org

Mackenzie Doerstling, MPH

CONTACT

212-241-8454

CoreResearch@mountsinai.org

Principal Investigator

David Putrino, PhD, PT

PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Study Locations (Sites)

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

New York, New York, 10029

United States

Collaborators and Investigators

Sponsor: Icahn School of Medicine at Mount Sinai

David Putrino, PhD, PT, PRINCIPAL_INVESTIGATOR, Icahn School of Medicine at Mount Sinai

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-09

Study Completion Date2026-02-01

Study Record Updates

Study Start Date2024-10-09

Study Completion Date2026-02-01

Terms related to this study

Keywords Provided by Researchers

Long Covid
Lyme Disease
ME/CFS
Lumbrokinase
Post-treatment lyme disease syndrome

Additional Relevant MeSH Terms

Long Covid
Post-treatment Lyme Disease Syndrome
Chronic Fatigue Syndrome
Myalgic Encephalomyelitis