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Enzyme Therapy

Lumbrokinase for Long COVID

Phase 1 & 2
Recruiting
Led By David Putrino, PhD, PT
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Formal diagnosis of Long Covid, Post-treatment Lyme disease syndrome, or ME/CFS from a physician
Actively symptomatic such that the 2011 International Criteria for ME/CFS is met at time of screening
Must not have
Diagnosis of an autoimmune condition such as Chronic EBV, Multiple Sclerosis, Hashimoto's Disease, etc.
Current use of antiplatelet or anticoagulation regimen
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial will test the use of Lumbrokinase (LK) as a treatment in three different groups of patients: those with Long Covid, Post-treatment Lyme disease syndrome, and Myalg

Who is the study for?
This trial is for individuals with Long Covid, Post-treatment Lyme disease syndrome (PTLDS), or Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). Specific eligibility criteria are not provided.
What is being tested?
The trial is testing Lumbrokinase (LK) as a potential treatment in three separate groups: those with Long Covid, PTLDS, and ME/CFS. It's a pilot study to see if the treatment is feasible.
What are the potential side effects?
Potential side effects of Lumbrokinase are not detailed here. Typically, patients may experience reactions similar to other enzyme treatments such as digestive discomfort or allergic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with Long Covid, Post-treatment Lyme disease syndrome, or ME/CFS by a doctor.
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I meet the criteria for ME/CFS with active symptoms.
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I have been diagnosed with Long Covid, Post-treatment Lyme disease syndrome, or ME/CFS.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with an autoimmune condition.
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I am currently taking medication to prevent blood clots.
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I have surgery planned during or right after the study.
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I have a history of bleeding or clotting issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
EuroQol Visual Analogue Scale Score (EQ-VAS)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Post-treatment Lyme Disease SyndromeExperimental Treatment1 Intervention
Boluoke® brand lumbrokinase capsules, 300,000 functional units (FUs) twice per day, daily for 6 weeks.
Group II: ME/CFSExperimental Treatment1 Intervention
Boluoke® brand lumbrokinase capsules, 300,000 functional units (FUs) twice per day, daily for 6 weeks.
Group III: Long CovidExperimental Treatment1 Intervention
Boluoke® brand lumbrokinase capsules, 300,000 functional units (FUs) twice per day, daily for 6 weeks.

Find a Location

Who is running the clinical trial?

Columbia UniversityOTHER
1,486 Previous Clinical Trials
2,663,070 Total Patients Enrolled
Icahn School of Medicine at Mount SinaiLead Sponsor
904 Previous Clinical Trials
541,701 Total Patients Enrolled
PolyBio Research FoundationUNKNOWN
2 Previous Clinical Trials
120 Total Patients Enrolled
~80 spots leftby Feb 2026
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