Purpose

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

Condition

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

ArmDescriptionAssigned Intervention
Experimental
Lithium
Lithium 10mg po qd
  • Drug: Lithium
    Lithium has multiple mechanisms of action including anti-inflammatory actions, which may be relevant for treating long COVID.
Placebo Comparator
Placebo
Placebo identically matching the lithium pills
  • Drug: Placebo
    Inactive pill

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.