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New treatment option for Long Covid
Official title Lumbrokinase for Adults With Long Covid, Post-treatment Lyme Disease Syndrome, and Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
ClinicalTrials.gov ID: NCT06511050
What this study is testing
- What it's testing
- 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)
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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
You likely can't join 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...
- 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
See the full eligibility criteria
- 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
- Disseminated "objective" manifestation with lab test confirmation of Bb infection
- Clinical history includes at least one of the following symptoms/signs, which are not better accounted for by another cause (MOA: medical records and/or self-report).
- Neurologic: Lymphocytic Meningitis ; Encephalitis; Encephalomyelitis Cranial Neuritis (especially facial palsy); Radiculoneuropathy; Other Neurologic Signs (with objective measures) : Encephalopathy, Polyneuropathy
- Carditis: 2nd or 3rd degree AV block; Myocarditis; Pericarditis
- Lyme arthritis: Recurrent joint swelling in one or more joints
- Dermatologic: Disseminated EM ("satellite") or Acrodermatitis atrophicans AND
- Lab test Confirmation (requires at least one of the Class 1 lab tests) (MOA: self-report \& documentation)
- Group 2. Probable
- 2A. Chronic Multisystem Symptoms attributed to Lyme disease (insufficient to meet Group 1) and not better explained by another diagnosis and patient has evidence of positive lab results on a Class 1 lab test (or 4 of 10...
- 2B. EM rash by history after exposure to a Lyme-endemic area but not previously diagnosed by a HCP and no photo or Class 1 lab test confirmation is available (MOA: self-report) OR
- 2C. Viral like illness (not better explained by other cause) with indeterminate or + enzyme immunoassay (EIA) with positive IgM WB or positive Class 1 lab test (within 4 weeks of illness onset after known exposure to a...
- 2D. Viral like illness (not better explained by other cause) with indeterminate or positive EIA with positive IgM WB or positive Class 1 lab test (within 6 months of illness onset after known exposure to a Lyme...
- (MOA: medical records, lab test and self-report)
- (MOA: lab test and self-report)
- ME/CFS
- Formal diagnosis of ME/CFS prior to 2020 from a physician
- Actively symptomatic such that the 2011 International Criteria for ME/CFS is met at time of screening
- 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
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.