lumbrokinase for adults with long covid, post-treatment lyme disease syndrome, and myalgic encephalomyelitis/chronic fatigue syndrome

Conditions: Long Covid; Post-treatment Lyme Disease Syndrome; Chronic Fatigue Syndrome; Myalgic Encephalomyelitis

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)


Eligibility criteria:
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

Keywords: long covid lyme disease me/cfs lumbrokinase post-treatment lyme disease syndrome