Effect of Lithium Therapy on Long COVID Symptoms
Purpose
This study will assess low-dose lithium's effects on several different symptoms experienced by long COVID patients.
Condition
- Long COVID
Eligibility
- Eligible Ages
- Between 18 Years and 80 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Criteria
1. Documented or self-reported positive test for COVID-19 ≥4 weeks prior to enrollment.
2. No fever for ≥4 weeks prior to enrollment.
3. 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.
4. Fatigue Severity Scale (FSS) score ≥28 or Brain Fog Severity Scale (BFSS) score ≥28
at baseline.
5. Beck Depression Inventory II score <24.
6. No change in any psychoactive or steroid medications for ≥30 days.
7. 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.
8. 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.
9. No history of fibromyalgia, chronic fatigue syndrome or progressive cognitive
disorder prior to COVID-19 infection.
10. No active medical, psychiatric or social problems that would interfere with
completing the study procedures in the opinion of the investigator.
11. No use of tobacco or marijuana products for >6 months and no current alcohol abuse
(≥4 drinks/day) or illicit drug use.
12. Not receiving or applying for disability payments or workman's compensation for long
COVID.
13. Not pregnant or nursing or planning to get pregnant over the next two months.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Lithium |
Lithium 10mg po qd |
|
Placebo Comparator Placebo |
Placebo identically matching the lithium pills |
|
Recruiting Locations
More Details
- NCT ID
- NCT05618587
- Status
- Completed
- Sponsor
- State University of New York at Buffalo
Detailed Description
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.