Clinical trial NCT06108297: Lithium Long COVID Dose-finding Study
Official title: Effect of Low-dose Lithium Therapy on Long COVID Symptoms: an Open-label, Dose-finding Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Long COVID
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
First posted: 2023-10-31
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: Fatigue Severity Scale (FSS)
timeFrame: Baseline to end-of-titration (up to 11 weeks)
measure: Brain Fog Severity Scale (BFSS)
timeFrame: Baseline to end-of-titration (up to 11 weeks)
Secondary outcomes:
measure: Well Being Scale
timeFrame: Baseline to end-of-titration (up to 11 weeks)
measure: Short Form-12 Health Survey
timeFrame: Baseline to end-of-titration (up to 11 weeks)
measure: FSS scores in those with FSS score ≥28 at baseline
timeFrame: Baseline to end-of-titration (up to 11 weeks)
measure: BFSS scores in those with FSS score ≥28 at baseline
timeFrame: Baseline to end-of-titration (up to 11 weeks)
measure: Modified Fatigue Impact Scale
timeFrame: Baseline to end-of-titration (up to 11 weeks)
measure: Perceived Deficits Questionnaire, 5-Item Version
timeFrame: Baseline to end-of-titration (up to 11 weeks)
measure: Beck Depression Inventory-II
timeFrame: Baseline to end-of-titration (up to 11 weeks)
measure: Generalized Anxiety Disorder Scale-2
timeFrame: Baseline to end-of-titration (up to 11 weeks)
measure: Headache and Body Pain Bother Scale
timeFrame: Baseline to end-of-titration (up to 11 weeks)
measure: Insomnia Severity Index
timeFrame: Baseline to end-of-titration (up to 11 weeks)
measure: Patient Global Impression of Change
timeFrame: End-of-titration (up to 11 weeks)
measure: Desire to Continue Therapy Scale
timeFrame: End-of-titration (up to 11 weeks)
Other outcomes:
Locations:
city: Williamsville
country: United States
facility: UBMD Neurology
state: New York
Study officials:
References: