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This open-label study will assess if lithium dosages of 30-45mg/day are associated with greater symptomatic benefit than dosages of 10-15mg/day previously assessed among 50 patients with long COVID.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lithium | Experimental | Lithium capsules titrated to 30-45mg/day based on individual patient subjective benefits and tolerability. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lithium | Dietary Supplement | Elemental lithium as lithium aspartate. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fatigue Severity Scale (FSS) | 7-item scale. Score range 1-49 with higher values signifying worse outcome | Baseline to end-of-titration (up to 11 weeks) |
| Brain Fog Severity Scale (BFSS) | 7-item scale. Score range 1-49 with higher values signifying worse outcome | Baseline to end-of-titration (up to 11 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Well Being Scale | Single-item question. Score range 0-10 with higher values signifying better outcome. | Baseline to end-of-titration (up to 11 weeks) |
| Short Form-12 Health Survey | 12-item quality of life scale. Score range 0-100 for both the Physical Component Score and the Mental Component Score with higher values signifying better outcomes. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UBMD Neurology | Williamsville | New York | 14221 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39356507 | Derived | Guttuso T Jr, Zhu J, Wilding GE. Lithium Aspartate for Long COVID Fatigue and Cognitive Dysfunction: A Randomized Clinical Trial. JAMA Netw Open. 2024 Oct 1;7(10):e2436874. doi: 10.1001/jamanetworkopen.2024.36874. |
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| ID | Term |
|---|---|
| D000094024 | Post-Acute COVID-19 Syndrome |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
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| ID | Term |
|---|---|
| D008094 | Lithium |
| ID | Term |
|---|---|
| D008672 | Metals, Alkali |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D019565 | Metals, Light |
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| Baseline to end-of-titration (up to 11 weeks) |
| FSS scores in those with FSS score ≥28 at baseline | 7-item scale. Score range 1-49 with higher values signifying worse outcome | Baseline to end-of-titration (up to 11 weeks) |
| BFSS scores in those with FSS score ≥28 at baseline | 7-item scale. Score range 1-49 with higher values signifying worse outcome | Baseline to end-of-titration (up to 11 weeks) |
| Modified Fatigue Impact Scale | 21-item scale. Score range 0-84 with higher values signifying worse outcome | Baseline to end-of-titration (up to 11 weeks) |
| Perceived Deficits Questionnaire, 5-Item Version | 5-item scale. Score range 1-20 with higher values signifying worse outcome | Baseline to end-of-titration (up to 11 weeks) |
| Beck Depression Inventory-II | 21-item scale. Score range 0-63 with higher values signifying worse outcome | Baseline to end-of-titration (up to 11 weeks) |
| Generalized Anxiety Disorder Scale-2 | 2-item scale. Score range 0-6 with higher values signifying worse outcome | Baseline to end-of-titration (up to 11 weeks) |
| Headache and Body Pain Bother Scale | 2-item scale. Score range 2-10 with higher values signifying worse outcome | Baseline to end-of-titration (up to 11 weeks) |
| Insomnia Severity Index | 7-item scale. Score range 0-28 with higher values signifying worse outcome | Baseline to end-of-titration (up to 11 weeks) |
| Patient Global Impression of Change | Single-item scale. Score range 1-7 with higher values signifying better outcome | End-of-titration (up to 11 weeks) |
| Desire to Continue Therapy Scale | Single-item scale. Score range 1-2 with higher value signifying better outcome | End-of-titration (up to 11 weeks) |
| 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 |
| D008670 |
| Metals |