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)
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).
Long Covid
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)
Parallel
Lumbrokinase
Dietary supplementBoluoke® brand lumbrokinase capsules will be taken daily for 6 weeks.
EuroQol Visual Analogue Scale Score (EQ-VAS)
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.
The EuroQol Five-Dimensional Health Questionnaire (EQ-5D-5L)
The EQ-5D-5L is a validated, standardized, generic instrument that is a preference-based health- related quality of life questionnaire. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate their health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. Full scale from 5 to 25, with higher score indicating poorer health outcomes.
10-Meter Walk Test
The scoring for the 10-meter walk test involves recording the time it takes to walk 10 meters and then calculating walking speed in meters per second (m/s). The test typically measures the time it takes to walk the middle 6 meters of a 10-meter walk, allowing for acceleration and deceleration.
Root mean square of successive differences between normal heartbeats (RMSSD)
The RMSSD is obtained by first calculating each successive time difference between heartbeats in ms. Then, each of the values is squared and the result is averaged before the square root of the total is obtained. This is a measure of parasympathetic nervous system function. Higher RMSSD values generally indicate greater parasympathetic activity and a more resilient heart.
BrainCheck Cognitive Assessment Battery
The BrainCheck software is an advanced digital cognitive assessment completed on a computer or tablet. Scores within one standard deviation of the mean are considered normal, while scores outside this range may suggest cognitive impairment.
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Icahn School of Medicine at Mount Sinai
Lead sponsor
Columbia University
Collaborator
PolyBio Research Foundation
Collaborator
