This study will assess low-dose lithium's effects on several different symptoms experienced by long COVID patients.
In this double-blind, placebo-controlled study, 50 patients with long COVID will be randomly assigned to either low-dose oral lithium or placebo therapy for three weeks. After the double-blind study phase, all patients will be provided with lithium therapy for two additional weeks. Study visits will occur at baseline and after the three-week double-blind study phase.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
52
University at Buffalo
Williamsville, New York, United States
Fatigue Severity Scale
7-item questionnaire assessing fatigue severity. Score range 1-49 with higher values signifying worse outcome
Time frame: Change from baseline to day 21
Brain Fog Severity Scale
7-item questionnaire assessing brain fog severity. Score range 1-49 with higher values signifying worse outcome
Time frame: Change from baseline to day 21
Patient Global Impression of Change (PGIC)
Change in symptoms on 7-point scale. Single-item scale. Score range 1-7 with higher values signifying better outcome
Time frame: Day 21
Well-Being Scale
Sense of well-being over past week on 10-point scale. Score range 0-10 with higher values signifying better outcome.
Time frame: Change from baseline to day 21
Short Form-12 Health Survey (1-week Modification)
Quality of life assessment over past week, PCS-subscale. 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.
Time frame: Change from baseline to day 21
Desire to Continue Therapy
Single Yes/No question. Single-item scale. Score range 1-2 with higher value signifying better outcome. Reported as % of respondents recording "yes".
Time frame: Day 21
Generalized Anxiety Disorder-2 Scale
2-item questionnaire assessing anxiety frequency over the past week. 2-item scale. Score range 0-6 with higher values signifying worse outcome
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Time frame: Change from baseline to day 21
Headache and Body Pain Bother Scale
2-item questionnaire assessing frequency of headaches and body pain over the past week, Headache score. 2-item scale. Score range 2-10 with higher values signifying worse outcome
Time frame: Change from baseline to day 21
Insomnia Severity Index
7-item questionnaire assessing insomnia severity over the past week. 7-item scale. Score range 0-28 with higher values signifying worse outcome.
Time frame: Change from baseline to day 21
Sense of Smell and Taste Change Scale
Subjective change from baseline on a 7-point scale (score range: 1-7) with higher scores indicating better outcomes. Scores of 1 and 7 indicate sense of smell and taste were "very much worse" or "very much improved", respectively, since the start of study treatment.
Time frame: Day 21
Digit Symbol Substitution Test
Validated cognitive test. Score range 0-100 with higher scores indicating a better outcome.
Time frame: Change from baseline to day 21
Delayed Recall Test
Validated cognitive test. Score range 0-5 with higher scores indicating better outcomes.
Time frame: Change from baseline to day 21