This will be a pilot multi-arm clinical trial investigating the feasibility ofLumbrokinase (LK) as an intervention in three clinical cohorts: - Long Covid (LC) - Post-treatment Lyme disease syndrome (PTLDS) - Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS)
Not Provided
Dietary Supplement: Lumbrokinase
Boluoke® brand lumbrokinase capsules will be taken daily for 6 weeks.
Other Name: Boluoke® Lumbrokinase
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
The Cohen Center for Recovery from Complex Chronic Illnesses (CoRE)
New York 5128581, New York 5128638, United States
Investigator: Mackenzie Doerstling, MPH
CoreResearch@mountsinai.org
Investigator: David Putrino
David Putrino, PhD, PT
212-241-8454
CoreResearch@mountsinai.org
Mackenzie Doerstling, MPH
212-241-8454
CoreResearch@mountsinai.org
David Putrino, PhD, PT, Principal Investigator
Icahn School of Medicine at Mount Sinai