Lumbrokinase for Adults With Long Covid, Post-treatment Lyme Disease Syndrome, and Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
Part of paid clinical trials in New York, New York.
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Study ID
- NCT06511050
- Phase
- PHASE1/PHASE2
- Status
- Recruiting
Conditions
- Chronic Fatigue Syndrome
- Long Covid
- Myalgic Encephalomyelitis
- Post-treatment Lyme Disease Syndrome
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Lumbrokinase — DIETARY_SUPPLEMENTBoluoke® brand lumbrokinase capsules will be taken daily for 6 weeks.
Study Details
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)
Key Dates
- Start date
- Oct 9, 2024
- Status verified
- Feb 2026
- Primary completion
- Dec 31, 2026
- Completion
- Dec 31, 2026
Study Design
- Enrollment
- 120 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Long CovidBoluoke® brand lumbrokinase capsules, 300,000 functional units (FUs) twice per day, daily for 6 weeks.
- Experimental: Post-treatment Lyme Disease SyndromeBoluoke® brand lumbrokinase capsules, 300,000 functional units (FUs) twice per day, daily for 6 weeks.
- Experimental: Myalgic Encephalomyelitis/Chronic Fatigue SyndromeBoluoke® brand lumbrokinase capsules, 300,000 functional units (FUs) twice per day, daily for 6 weeks.
Primary Outcome Measure
EuroQol Visual Analogue Scale Score (EQ-VAS) [ Time Frame: Up to 12 weeks ]
Central Contacts
- David Putrino, PhD, PT212-241-8454
- Mackenzie Doerstling, MPH212-241-8454
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| The Cohen Center for Recovery from Complex Chronic Illnesses (CoRE) | New York | New York | 10029 | Mackenzie Doerstling, MPH David Putrino (PRINCIPAL_INVESTIGATOR) |
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