Effect of Lithium Therapy on Long COVID Symptoms
- Registration Number
- NCT05618587
- Lead Sponsor
- State University of New York at Buffalo
- Brief Summary
This study will assess low-dose lithium's effects on several different symptoms experienced by long COVID patients.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 52
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lithium Lithium Lithium 10mg po qd Placebo Placebo Placebo identically matching the lithium pills
- Primary Outcome Measures
Name Time Method Fatigue Severity Scale Change from baseline to day 21 7-item questionnaire assessing fatigue severity. Score range 1-49 with higher values signifying worse outcome
Brain Fog Severity Scale Change from baseline to day 21 7-item questionnaire assessing brain fog severity. Score range 1-49 with higher values signifying worse outcome
- Secondary Outcome Measures
Name Time Method Patient Global Impression of Change (PGIC) Day 21 Change in symptoms on 7-point scale. Single-item scale. Score range 1-7 with higher values signifying better outcome
Well-Being Scale Change from baseline to day 21 Sense of well-being over past week on 10-point scale. Score range 0-10 with higher values signifying better outcome.
Short Form-12 Health Survey (1-week Modification) Change from baseline to day 21 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.
Desire to Continue Therapy Day 21 Single Yes/No question. Single-item scale. Score range 1-2 with higher value signifying better outcome. Reported as % of respondents recording "yes".
Generalized Anxiety Disorder-2 Scale Change from baseline to day 21 2-item questionnaire assessing anxiety frequency over the past week. 2-item scale. Score range 0-6 with higher values signifying worse outcome
Headache and Body Pain Bother Scale Change from baseline to day 21 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
Insomnia Severity Index Change from baseline to day 21 7-item questionnaire assessing insomnia severity over the past week. 7-item scale. Score range 0-28 with higher values signifying worse outcome.
Sense of Smell and Taste Change Scale Day 21 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.
Digit Symbol Substitution Test Change from baseline to day 21 Validated cognitive test. Score range 0-100 with higher scores indicating a better outcome.
Delayed Recall Test Change from baseline to day 21 Validated cognitive test. Score range 0-5 with higher scores indicating better outcomes.
Trial Locations
- Locations (1)
University at Buffalo
🇺🇸Williamsville, New York, United States