Effect of Lithium Therapy on Long COVID Symptoms

Study Overview
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Brief Summary
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This study will assess low-dose lithium's effects on several different symptoms experienced by long COVID patients.

Detailed Description
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In this double-blind, placebo-controlled study, 50 patients with long COVID will be randomly assigned to either low-dose oral lithium or placebo therapy for three weeks. After the double-blind study phase, all patients will be provided with lithium therapy for two additional weeks. Study visits will occur at baseline and after the three-week double-blind study phase.

Official Title
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Effect of Low-dose Lithium Therapy on Long COVID Symptoms: a Randomized Controlled Trial.

Conditions
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Long COVID

Intervention / Treatment
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* Drug: Lithium
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Documented or self-reported positive test for COVID-19 ≥4 weeks prior to enrollment. No fever for ≥4 weeks prior to enrollment. Reports fatigue and/or brain fog (i.e. concentration or memory impairment) for ≥4 weeks prior to enrollment on the PASC-Specific Symptom questionnaire beginning after infection with COVID-19. Fatigue Severity Scale (FSS) score ≥28 or Brain Fog Severity Scale (BFSS) score ≥28 at baseline. Beck Depression Inventory II score <24. No change in any psychoactive or steroid medications for ≥30 days. No plan to change any psychoactive, steroid or diuretic medication for ≥5 weeks and not planning on obtaining a COVID vaccine within the next 5 weeks. Not using any long COVID therapies felt to be worsening the patient's symptoms or starting a long COVID therapy within the next 5 weeks. No history of fibromyalgia, chronic fatigue syndrome or progressive cognitive disorder prior to COVID-19 infection. No active medical, psychiatric or social problems that would interfere with completing the study procedures in the opinion of the investigator. No use of tobacco or marijuana products for >6 months and no current alcohol abuse (≥4 drinks/day) or illicit drug use. Not receiving or applying for disability payments or workman's compensation for long COVID. Not pregnant or nursing or planning to get pregnant over the next two months.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lithium<br>Lithium 10mg po qd | Drug: Lithium<br>* Lithium has multiple mechanisms of action including anti-inflammatory actions, which may be relevant for treating long COVID.<br>|
| Placebo Comparator: Placebo<br>Placebo identically matching the lithium pills | Drug: Placebo<br>* Inactive pill<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue Severity Scale | 7-item questionnaire assessing fatigue severity | Change from baseline to day 21 | 
| Brain Fog Severity Scale | 7-item questionnaire assessing brain fog severity | Change from baseline to day 21 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Global Impression of Change (PGIC) | Change in symptoms on 7-point scale | Day 21 | 
| Well-Being Scale | Sense of well-being over past week on 10-point scale | Change from baseline to day 21 | 
| Short Form-12 Health Survey (1-week modification) | Quality of life assessment over past week | Change from baseline to day 21 | 
| Desire to Continue Therapy | Single Yes/No question | Day 21 | 
| Generalized Anxiety Disorder-2 Scale | 2-item questionnaire assessing anxiety frequency over the past week | Change from baseline to day 21 | 
| Headache and Body Pain Bother Scale | 2-item questionnaire assessing frequency of headaches and body pain over the past week | Change from baseline to day 21 | 
| Insomnia Severity Index | 7-item questionnaire assessing insomnia severity over the past week | Change from baseline to day 21 | 
| Sense of Smell and Taste Change Scale | Subjective change from baseline on a 7-point scale | Day 21 | 
| Digit Symbol Substitution Test | Validated cognitive test | Change from baseline to day 21 | 
| Delayed Recall Test | Validated cognitive test | Change from baseline to day 21 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lithium, long COVID