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Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Enrolled from November 2022-July 2023 in lithium long COVID clinical trial at UB. 2. Reports bothersome fatigue and/or brain fog while not taking lithium or, reports satisfactory benefit to these symptoms while taking lithium. 3. 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. 4. 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

  1. Fever or signs of acute infection in last 4 weeks. 2. COVID vaccine administered within 4 weeks. No change in any psychoactive or steroid medications for ≥30 days. 3. Plan to change a psychoactive, steroid or diuretic medication in next 5 weeks. 4. History of heart attack or stroke within the previous year. 5. Active medical, psychiatric or social problem that would interfere with completing the study procedures in the opinion of the investigator. 6. Daily NSAID use. 7. Pregnant or nursing or planning to get pregnant over the next 11 weeks.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

More Details

NCT ID
NCT06108297
Status
Completed
Sponsor
State University of New York at Buffalo

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.