Status:
COMPLETED
Lithium Long COVID Dose-finding Study
Lead Sponsor:
State University of New York at Buffalo
Conditions:
Long COVID
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
October 12 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 2 2024
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT06108297
Start Date
October 12 2023
End Date
May 2 2024
Last Update
October 22 2024
Active Locations (1)
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1
UBMD Neurology
Williamsville, New York, United States, 14221