Lithium Long COVID Dose-finding Study
Completed · Phase 1
Conditions studied: Long COVID
In brief
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.
Key facts
- Study ID
- NCT06108297
- Run by
- State University of New York at Buffalo
- People needed
- 5
- Starts
- 2023-10-12
- Expected to finish
- 2024-05-02
- Last updated by the study team
- 2024-10-22
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Enrolled from November 2022-July 2023 in lithium long COVID clinical trial at UB.
- Reports bothersome fatigue and/or brain fog while not taking lithium or, reports satisfactory benefit to these symptoms while taking lithium.
- 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.
- 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.
You may not qualify if…
- Fever or signs of acute infection in last 4 weeks.
- COVID vaccine administered within 4 weeks. No change in any psychoactive or steroid medications for ≥30 days.
- Plan to change a psychoactive, steroid or diuretic medication in next 5 weeks.
- History of heart attack or stroke within the previous year.
- Active medical, psychiatric or social problem that would interfere with completing the study procedures in the opinion of the investigator.
- Daily NSAID use.
- Pregnant or nursing or planning to get pregnant over the next 11 weeks.
Where it is running
- UBMD Neurology — Williamsville, New York, United States
Full record on ClinicalTrials.gov
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