Lithium Long COVID Dose-finding Study
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Lithium Lithium capsules titrated to 30-45mg/day based on individual patient subjective benefits and tolerability. |
Dietary Supplement: Lithium
Elemental lithium as lithium aspartate.
|
Outcome Measures
Primary Outcome Measures
- Fatigue Severity Scale (FSS) [Baseline to end-of-titration (up to 11 weeks)]
7-item scale. Score range 1-49 with higher values signifying worse outcome
- Brain Fog Severity Scale (BFSS) [Baseline to end-of-titration (up to 11 weeks)]
7-item scale. Score range 1-49 with higher values signifying worse outcome
Secondary Outcome Measures
- Well Being Scale [Baseline to end-of-titration (up to 11 weeks)]
Single-item question. Score range 0-10 with higher values signifying better outcome.
- Short Form-12 Health Survey [Baseline to end-of-titration (up to 11 weeks)]
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.
- FSS scores in those with FSS score ≥28 at baseline [Baseline to end-of-titration (up to 11 weeks)]
7-item scale. Score range 1-49 with higher values signifying worse outcome
- BFSS scores in those with FSS score ≥28 at baseline [Baseline to end-of-titration (up to 11 weeks)]
7-item scale. Score range 1-49 with higher values signifying worse outcome
- Modified Fatigue Impact Scale [Baseline to end-of-titration (up to 11 weeks)]
21-item scale. Score range 0-84 with higher values signifying worse outcome
- Perceived Deficits Questionnaire, 5-Item Version [Baseline to end-of-titration (up to 11 weeks)]
5-item scale. Score range 1-20 with higher values signifying worse outcome
- Beck Depression Inventory-II [Baseline to end-of-titration (up to 11 weeks)]
21-item scale. Score range 0-63 with higher values signifying worse outcome
- Generalized Anxiety Disorder Scale-2 [Baseline to end-of-titration (up to 11 weeks)]
2-item scale. Score range 0-6 with higher values signifying worse outcome
- Headache and Body Pain Bother Scale [Baseline to end-of-titration (up to 11 weeks)]
2-item scale. Score range 2-10 with higher values signifying worse outcome
- Insomnia Severity Index [Baseline to end-of-titration (up to 11 weeks)]
7-item scale. Score range 0-28 with higher values signifying worse outcome
- Patient Global Impression of Change [End-of-titration (up to 11 weeks)]
Single-item scale. Score range 1-7 with higher values signifying better outcome
- Desire to Continue Therapy Scale [End-of-titration (up to 11 weeks)]
Single-item scale. Score range 1-2 with higher value signifying better outcome
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Enrolled from November 2022-July 2023 in lithium long COVID clinical trial at UB.
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Reports bothersome fatigue and/or brain fog while not taking lithium or, reports satisfactory benefit to these symptoms while taking lithium.
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Fatigue Severity Scale (FSS) score ≥28 or Brain Fog Severity Scale (BFSS) score ≥28 at baseline or; FSS <28, BFSS <28 and PGIC at Visit 1 of "much improved" or "very much improved" while taking lithium.
-
Did not "respond" to placebo therapy, based on the responder analyses outlined in the Preliminary data section above, defined as a ≥18-point reduction FSS or ≥15-point reduction in BFSS from baseline to the end-of-double-blind study phase while receiving placebo therapy.
Exclusion Criteria:
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Fever or signs of acute infection in last 4 weeks.
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COVID vaccine administered within 4 weeks. No change in any psychoactive or steroid medications for ≥30 days.
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Plan to change a psychoactive, steroid or diuretic medication in next 5 weeks.
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History of heart attack or stroke within the previous year.
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Active medical, psychiatric or social problem that would interfere with completing the study procedures in the opinion of the investigator.
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Daily NSAID use.
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Pregnant or nursing or planning to get pregnant over the next 11 weeks.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- State University of New York at Buffalo
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STUDY00007796