Actively Recruiting
Investigating the Effects of Lumbrokinase in Adults With Long Covid, Post-treatment Lyme Disease Syndrome, and Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
Led by Icahn School of Medicine at Mount Sinai · Updated on 2026-03-13
120
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
I
Icahn School of Medicine at Mount Sinai
Lead Sponsor
C
Columbia University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of Lumbrokinase (LK), a dietary supplement, in adults with Long Covid, Post-treatment Lyme Disease Syndrome (PTLDS), and Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). This pilot multi-arm clinical trial aims to investigate the feasibility of Lumbrokinase as an intervention across these three conditions, which share overlapping symptoms and impacts on health. The study is sponsored by the Icahn School of Medicine at Mount Sinai and includes adults aged 18 and older. Participants in this study will take Boluoke4 brand lumbrokinase capsules, each containing 300,000 functional units, twice daily for a total of 6 weeks. The trial includes three experimental groups, one for each condition: Long Covid, Post-treatment Lyme Disease Syndrome, and ME/CFS. There is no randomization or placebo control, and all participants receive the same dose and schedule of Lumbrokinase. Throughout the 12-week study period, participants will be monitored and assessed with various tools to measure quality of life, physical function, cognitive ability, symptoms, and mental health. Assessments include the EuroQol Visual Analogue Scale, 10-Meter Walk Test, cognitive batteries, and symptom questionnaires like the Fatigue Severity Scale and anxiety and depression screens. Safety and adherence will be tracked, and data collected up to 12 weeks after starting the treatment.
CONDITIONS
Brief Title
Lumbrokinase for Adults With Long Covid, Post-treatment Lyme Disease Syndrome, and Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Any gender
- Aged 18 or older
- Baseline EuroQol Visual Analogue Scale (EQ-VAS) score of 70 or less
- EQ-VAS score before the initial infection of 80 or more (collected during baseline survey)
- Diagnosed with only one of the following: Long Covid, Post-treatment Lyme Disease Syndrome, or Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
- For Long Covid: Documented history of confirmed or suspected COVID-19 at least 3 months before contact, with formal diagnosis by a physician
- For Post-treatment Lyme Disease Syndrome: Meets Columbia Clinical Trial Network PTLDS diagnostic criteria (Group 1 or Group 2) with required clinical history and lab confirmation
- For ME/CFS: Formal diagnosis prior to 2020 by a physician and actively symptomatic meeting 2011 International Criteria at screening
You will not qualify if you...
- Current use of antiplatelet or anticoagulant medications
- Diagnosis of autoimmune conditions such as Chronic EBV, Multiple Sclerosis, or Hashimoto's Disease affecting immune profiling
- Pregnancy or breastfeeding
- Known allergy to earthworms (Lumbrokinase source)
- History of bleeding or clotting disorders
- Scheduled surgery during or immediately after the study period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 weeks
Participants take Boluoke® brand lumbrokinase capsules, 300,000 functional units twice per day for 6 weeks.
Regular visits during treatment as scheduled by the study
Duration - Up to 6 weeks after treatment (to total 12 weeks from start)
Participants are monitored for up to 12 weeks after treatment to assess health status and symptoms.
Visits to complete assessments up to 12 weeks
Trial Site Locations
Total: 1 location
1
The Cohen Center for Recovery from Complex Chronic Illnesses (CoRE)
New York, New York, United States, 10029
Actively Recruiting
Research Team
D
David Putrino, PhD, PT
M
Mackenzie Doerstling, MPH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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