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

Официальное название

Investigating the Effects of Lumbrokinase in Adults With Long Covid, Post-treatment Lyme Disease Syndrome, and Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

Обзор

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)

Вмешательства

• Пищевая добавка Lumbrokinase
  Boluoke® brand lumbrokinase capsules will be taken daily for 6 weeks.

Первичные конечные точки

• EuroQol Visual Analogue Scale Score (EQ-VAS) [Срок оценки: Up to 12 weeks]

Вторичные конечные точки (12)

• The EuroQol Five-Dimensional Health Questionnaire (EQ-5D-5L) [Срок оценки: Up to 12 weeks]
• 10-Meter Walk Test [Срок оценки: Up to 12 weeks]
• Root mean square of successive differences between normal heartbeats (RMSSD) [Срок оценки: Up to 12 weeks]
• BrainCheck Cognitive Assessment Battery [Срок оценки: Up to 12 weeks]
• General Symptom Questionnaire (GSQ-30) [Срок оценки: Up to 12 weeks]
• Medical Research Council Breathlessness Scale (MRC) [Срок оценки: Up to 12 weeks]
• Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS) [Срок оценки: Up to 12 weeks]
• Patient Health Questionnaire (PHQ-2) [Срок оценки: Up to 12 weeks]
• Generalized Anxiety Disorder (GAD-7) [Срок оценки: Up to 12 weeks]
• Neuro-QoL™ v2.0 Cognitive Function-Short Form [Срок оценки: Up to 12 weeks]
• Fatigue Severity Scale [Срок оценки: Up to 12 weeks]
• DePaul Post-Exertional Malaise Questionnaire (DSQ) [Срок оценки: Up to 12 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• The Cohen Center for Recovery from Complex Chronic Illnesses (CoRE) — New York

Идентификаторы

NCT: NCT06511050 · STUDY-24-00154

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗