Recruiting

Phase 1

Phase 2

LumbrokinaseLumbrokinase for Adults With Long Covid, Post-treatment Lyme Disease Syndrome, and Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT06511050

Conditions

Long Covid

Post-treatment Lyme Disease Syndrome

Chronic Fatigue Syndrome

Myalgic Encephalomyelitis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Lumbrokinase

Study Details

Brief summary:

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)

Conditions

Long Covid

Post-treatment Lyme Disease Syndrome

Chronic Fatigue Syndrome

Myalgic Encephalomyelitis

Study ID

NCT06511050

Start date

Oct 9, 2024

Status verified date

Feb, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

120 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Long Covid

Boluoke® brand lumbrokinase capsules, 300,000 functional units (FUs) twice per day, daily for 6 weeks.

experimental: Post-treatment Lyme Disease Syndrome

Boluoke® brand lumbrokinase capsules, 300,000 functional units (FUs) twice per day, daily for 6 weeks.

experimental: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

Boluoke® brand lumbrokinase capsules, 300,000 functional units (FUs) twice per day, daily for 6 weeks.

Interventions

Lumbrokinase

Boluoke® brand lumbrokinase capsules will be taken daily for 6 weeks.

Primary outcome measure

EuroQol Visual Analogue Scale Score (EQ-VAS) [ Time Frame: Up to 12 weeks ]

Central Contacts and Locations

Central contacts

David Putrino, PhD, PT

212-241-8454 CoreResearch@mountsinai.org

Mackenzie Doerstling, MPH

212-241-8454 CoreResearch@mountsinai.org

Locations

The Cohen Center for Recovery from Complex Chronic Illnesses (CoRE)

Recruiting

New York, New York, United States, 10029

Contacts

Mackenzie Doerstling, MPH

CoreResearch@mountsinai.org

Principal Investigator:

David Putrino

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

Mar 13, 2026

Last verified

Feb, 2026

Keywords

Long Covid
Lyme Disease
ME/CFS
Lumbrokinase
Post-treatment Lyme disease syndrome

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-19. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2026-03-13.