Earthworm enzyme trial aims to ease long covid and chronic fatigue
NCT ID NCT06511050
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a dietary supplement called lumbrokinase in 120 adults with Long Covid, post-treatment Lyme disease syndrome, or ME/CFS. Participants take the supplement daily for 6 weeks. The goal is to see if it improves overall health and quality of life, as measured by a simple health rating scale.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- lumbrokinase (a dietary supplement derived from earthworms)
- What this could lead to
- If it works, this could point toward a new way to ease symptoms and improve quality of life for people with these chronic fatigue conditions.
- What could go wrong
- This is an early pilot study with only 120 people, so results may not apply widely. The supplement may not work or could cause side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2024
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion 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 bands for IgG Western blot (WB)) (MOA: self-report with lab documentation Class 1 lab test confirmation (excluding IgM WB) Highly suggestive IgG WB (4 of 10 bands) OR * 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 Lyme high-incidence area for standard two-tiered (STT) IgM) (MOA: medical records, lab test and self-report) (MOA: lab test and self-report) OR * 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 high-incidence area for standard two-tiered (STT) IgM) * (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 Exclusion Criteria: * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
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Contact
Email: •••••@•••••
Locations
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The Cohen Center for Recovery from Complex Chronic Illnesses (CoRE)
RECRUITINGNew York, New York, 10029, United States
Contact Email: •••••@•••••
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can slow breathing retrain the nervous system to fight long COVID?
- Can a brain zapping headset restore focus after long COVID?
- Mindfulness may offer relief for long COVID sufferers
- Can wearables decode the mystery of fatigue?
- Beetroot juice: a natural boost against long COVID fatigue?