Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Columbia University | OTHER |
| PolyBio Research Foundation | OTHER |
Not provided
Not provided
Not provided
Not provided
This will be a pilot multi-arm clinical trial investigating the feasibility of Lumbrokinase (LK) as an intervention in three clinical cohorts:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Long Covid | Experimental | Boluoke® brand lumbrokinase capsules, 300,000 functional units (FUs) twice per day, daily for 6 weeks. |
|
| Post-treatment Lyme Disease Syndrome | Experimental | Boluoke® brand lumbrokinase capsules, 300,000 functional units (FUs) twice per day, daily for 6 weeks. |
|
| Myalgic Encephalomyelitis/Chronic Fatigue Syndrome | Experimental | Boluoke® brand lumbrokinase capsules, 300,000 functional units (FUs) twice per day, daily for 6 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lumbrokinase | Dietary Supplement | Boluoke® brand lumbrokinase capsules will be taken daily for 6 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| EuroQol Visual Analogue Scale Score (EQ-VAS) | The EQ VAS is a visual analogue scale that allows individuals to rate their overall health from 0 (worst imaginable health) to 100 (best imaginable health), providing a quantitative measure of health as judged by the patient. | Up to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The EuroQol Five-Dimensional Health Questionnaire (EQ-5D-5L) | The EQ-5D-5L is a validated, standardized, generic instrument that is a preference-based health- related quality of life questionnaire. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate their health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. Full scale from 5 to 25, with higher score indicating poorer health outcomes. |
Not provided
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
Group 2. Probable
(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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David Putrino, PhD, PT | Contact | 212-241-8454 | CoreResearch@mountsinai.org | |
| Mackenzie Doerstling, MPH | Contact | 212-241-8454 | CoreResearch@mountsinai.org |
| Name | Affiliation | Role |
|---|---|---|
| David Putrino, PhD, PT | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Cohen Center for Recovery from Complex Chronic Illnesses (CoRE) | Recruiting | New York | New York | 10029 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Up to 12 weeks |
| 10-Meter Walk Test | The scoring for the 10-meter walk test involves recording the time it takes to walk 10 meters and then calculating walking speed in meters per second (m/s). The test typically measures the time it takes to walk the middle 6 meters of a 10-meter walk, allowing for acceleration and deceleration. | Up to 12 weeks |
| Root mean square of successive differences between normal heartbeats (RMSSD) | The RMSSD is obtained by first calculating each successive time difference between heartbeats in ms. Then, each of the values is squared and the result is averaged before the square root of the total is obtained. This is a measure of parasympathetic nervous system function. Higher RMSSD values generally indicate greater parasympathetic activity and a more resilient heart. | Up to 12 weeks |
| BrainCheck Cognitive Assessment Battery | The BrainCheck software is an advanced digital cognitive assessment completed on a computer or tablet. Scores within one standard deviation of the mean are considered normal, while scores outside this range may suggest cognitive impairment. | Up to 12 weeks |
| General Symptom Questionnaire (GSQ-30) | The General Symptom Questionnaire-30 (GSQ-30) is a valid and reliable instrument to assess symptom burden among patients with acute and post-treatment. The GSQ-30 total score ranges from 0 to 120, with higher scores indicating a greater symptom burden. | Up to 12 weeks |
| Medical Research Council Breathlessness Scale (MRC) | The General Symptom Questionnaire-30 (GSQ-30) is a valid and reliable instrument to assess symptom burden among patients with acute and post-treatment. The GSQ-30 total score ranges from 0 to 120, with higher scores indicating a greater symptom burden. | Up to 12 weeks |
| Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS) | The Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) is a tool used to identify and classify pain, particularly neuropathic pain, based on a patient's reported symptoms and signs of nerve damage. A score of 12 or more on the LANSS is generally considered indicative of neuropathic pain. | Up to 12 weeks |
| Patient Health Questionnaire (PHQ-2) | A PHQ-2 score ranges from 0 to 6, with 3 being the optimal cut-off point for depression screening. A score of 3 or higher indicates a high probability of major depressive disorder. A score of 2 or higher may be preferred in situations where clinicians want to ensure that few cases of depression are missed. | Up to 12 weeks |
| Generalized Anxiety Disorder (GAD-7) | The GAD-7 is a 7-item scale developed and validated to identify generalized anxiety disorder and its severity. It assesses the frequency of 7 anxiety symptoms and scores the responses from 0 ("Not at all") to 3 ("Nearly every day"). Total scores of 5, 10, and 15 correspond to mild, moderate, and severe generalized anxiety disorder, respectively. Full scale from 0-21, with higher score indicating more symptoms. | Up to 12 weeks |
| Neuro-QoL™ v2.0 Cognitive Function-Short Form | The Neuro-QoL Cognitive Function v2.0 short form assesses perceived difficulties in cognitive abilities, including memory, attention, decision making, planning, organizing, calculating, remembering, and learning. The short form consists of 8 questions assessed on a 5-point Likert scale, resulting in a raw score range of 8 to 40. A raw score is then converted to a T-score using conversion tables. Scores 0.5 - 1.0 SD worse than the mean (T-score 40-45) = mild symptoms/impairment. Scores 1.0 - 2.0 SD worse than the mean (T-score 30-40) = moderate symptoms/impairment. Scores 2.0 SD or more worse than the mean (T-score below 30) = severe symptoms/impairment. | Up to 12 weeks |
| Fatigue Severity Scale | The Fatigue Severity Scale (FSS) uses a 7-point scale (1-7) to assess fatigue, with higher scores indicating greater severity, and a total score ranging from 9 to 63. Higher scores indicate more severe fatigue. | Up to 12 weeks |
| DePaul Post-Exertional Malaise Questionnaire (DSQ) | The DSQ is designed to evaluate 54 classic ME/CFS symptoms, including fatigue, post-exertional malaise, sleep, pain, neurological/cognitive impairments, and autonomic, neuroendocrine, and immune symptoms. Each symptom's frequency and intensity are rated on a 5-point scale (0-4). Frequency and severity scores are multiplied by 25, added together, and then divided by 2 to create a composite frequency/severity score for each symptom. These scores range from 0 to 100, with higher scores indicating a greater symptom burden. | Up to 12 weeks |
| ID | Term |
|---|---|
| D000094024 | Post-Acute COVID-19 Syndrome |
| D000077342 | Post-Lyme Disease Syndrome |
| D015673 | Fatigue Syndrome, Chronic |
| D008193 | Lyme Disease |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D001899 | Borrelia Infections |
| D013145 | Spirochaetales Infections |
| D017282 | Tick-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D004679 | Encephalomyelitis |
| D000090862 | Neuroinflammatory Diseases |
| D009422 | Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C083421 | lumbrokinase |
Not provided
Not provided
Not provided