Long COVID
Conditions
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.
Interventions
DIETARY_SUPPLEMENTLithium
Elemental lithium as lithium aspartate.
Sponsors
State University of New York at Buffalo
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue Severity Scale (FSS) | Baseline to end-of-titration (up to 11 weeks) | 7-item scale. Score range 1-49 with higher values signifying worse outcome |
| Brain Fog Severity Scale (BFSS) | Baseline to end-of-titration (up to 11 weeks) | 7-item scale. Score range 1-49 with higher values signifying worse outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| FSS scores in those with FSS score ≥28 at baseline | Baseline to end-of-titration (up to 11 weeks) | 7-item scale. Score range 1-49 with higher values signifying worse outcome |
| BFSS scores in those with FSS score ≥28 at baseline | Baseline to end-of-titration (up to 11 weeks) | 7-item scale. Score range 1-49 with higher values signifying worse outcome |
| Modified Fatigue Impact Scale | Baseline to end-of-titration (up to 11 weeks) | 21-item scale. Score range 0-84 with higher values signifying worse outcome |
| Perceived Deficits Questionnaire, 5-Item Version | Baseline to end-of-titration (up to 11 weeks) | 5-item scale. Score range 1-20 with higher values signifying worse outcome |
| Beck Depression Inventory-II | Baseline to end-of-titration (up to 11 weeks) | 21-item scale. Score range 0-63 with higher values signifying worse outcome |
| Well Being Scale | Baseline to end-of-titration (up to 11 weeks) | Single-item question. Score range 0-10 with higher values signifying better outcome. |
| Headache and Body Pain Bother Scale | Baseline to end-of-titration (up to 11 weeks) | 2-item scale. Score range 2-10 with higher values signifying worse outcome |
| Insomnia Severity Index | Baseline to end-of-titration (up to 11 weeks) | 7-item scale. Score range 0-28 with higher values signifying worse outcome |
| Patient Global Impression of Change | End-of-titration (up to 11 weeks) | Single-item scale. Score range 1-7 with higher values signifying better outcome |
| Desire to Continue Therapy Scale | End-of-titration (up to 11 weeks) | Single-item scale. Score range 1-2 with higher value signifying better outcome |
| Generalized Anxiety Disorder Scale-2 | Baseline to end-of-titration (up to 11 weeks) | 2-item scale. Score range 0-6 with higher values signifying worse outcome |
| Short Form-12 Health Survey | Baseline to end-of-titration (up to 11 weeks) | 12-item quality of life scale. Score range 0-100 for both the Physical Component Score and the Mental Component Score with higher values signifying better outcomes. |
Countries
United States
Outcome results
None listed