Lumbrokinase for Adults With Long Covid, Post-treatment Lyme Disease Syndrome, and Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
Investigating the Effects of Lumbrokinase in Adults With Long Covid, Post-treatment Lyme Disease Syndrome, and Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
1 other identifier
interventional
120
1 country
1
Brief 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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Oct 2024
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 16, 2024
CompletedFirst Posted
Study publicly available on registry
July 19, 2024
CompletedStudy Start
First participant enrolled
October 9, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
March 13, 2026
February 1, 2026
2.1 years
July 16, 2024
March 11, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Up to 12 weeks
Secondary Outcomes (12)
The EuroQol Five-Dimensional Health Questionnaire (EQ-5D-5L)
Up to 12 weeks
10-Meter Walk Test
Up to 12 weeks
Root mean square of successive differences between normal heartbeats (RMSSD)
Up to 12 weeks
BrainCheck Cognitive Assessment Battery
Up to 12 weeks
General Symptom Questionnaire (GSQ-30)
Up to 12 weeks
- +7 more secondary outcomes
Study Arms (3)
Long Covid
EXPERIMENTALBoluoke® brand lumbrokinase capsules, 300,000 functional units (FUs) twice per day, daily for 6 weeks.
Post-treatment Lyme Disease Syndrome
EXPERIMENTALBoluoke® brand lumbrokinase capsules, 300,000 functional units (FUs) twice per day, daily for 6 weeks.
Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
EXPERIMENTALBoluoke® brand lumbrokinase capsules, 300,000 functional units (FUs) twice per day, daily for 6 weeks.
Interventions
Boluoke® brand lumbrokinase capsules will be taken daily for 6 weeks.
Eligibility Criteria
You may qualify if:
- 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
- +17 more criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Icahn School of Medicine at Mount Sinailead
- Columbia Universitycollaborator
- PolyBio Research Foundationcollaborator
Study Sites (1)
The Cohen Center for Recovery from Complex Chronic Illnesses (CoRE)
New York, New York, 10029, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Putrino, PhD, PT
Icahn School of Medicine at Mount Sinai
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 16, 2024
First Posted
July 19, 2024
Study Start
October 9, 2024
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
March 13, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share