Lithium Long COVID Dose-finding Study

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Low-dose Lithium Therapy on Long COVID Symptoms: an Open-label, Dose-finding Study.

Conditions
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Long COVID

Intervention / Treatment
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* Dietary Supplement: Lithium


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Enrolled from November 2022-July 2023 in lithium long COVID clinical trial at UB. Reports bothersome fatigue and/or brain fog while not taking lithium or, reports satisfactory benefit to these symptoms while taking lithium. 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: Fever or signs of acute infection in last 4 weeks. COVID vaccine administered within 4 weeks. No change in any psychoactive or steroid medications for ≥30 days. Plan to change a psychoactive, steroid or diuretic medication in next 5 weeks. History of heart attack or stroke within the previous year. Active medical, psychiatric or social problem that would interfere with completing the study procedures in the opinion of the investigator. Daily NSAID use. Pregnant or nursing or planning to get pregnant over the next 11 weeks.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lithium<br>Lithium capsules titrated to 30-45mg/day based on individual patient subjective benefits and tolerability. | Dietary Supplement: Lithium<br>* Elemental lithium as lithium aspartate.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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) |