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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 belowSelect...
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:Select...
I have been diagnosed with an autoimmune condition.
Select...
I am currently taking medication to prevent blood clots.
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I have surgery planned during or right after the study.
Select...
I have a history of bleeding or clotting issues.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 weeks
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
1,498 Previous Clinical Trials
2,768,861 Total Patients Enrolled
Icahn School of Medicine at Mount SinaiLead Sponsor
914 Previous Clinical Trials
572,781 Total Patients Enrolled
PolyBio Research FoundationUNKNOWN
2 Previous Clinical Trials
126 Total Patients Enrolled
David Putrino, PhD, PTPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
1 Previous Clinical Trials
90 Total Patients Enrolled