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

This open-label study will assess if lithium dosages of 30-45mg/day are associated withgreater symptomatic benefit than dosages of 10-15mg/day previously assessed among 50patients with long COVID.

Detailed Description

Not Provided

Completed
Long Covid

Dietary Supplement: Lithium

Elemental lithium as lithium aspartate.

Eligibility Criteria

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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 80 Years
Countries
United States
Locations

UBMD Neurology
Williamsville 5144588, New York 5128638, United States

Not Provided

State University of New York at Buffalo
NCT Number
MeSH Terms
Post-Acute COVID-19 Syndrome
Lithium