Clinical trial NCT05618587: Effect of Lithium Therapy on Long COVID Symptoms
Official title: Effect of Low-dose Lithium Therapy on Long COVID Symptoms: a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Long COVID
Keywords: lithium, long COVID
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2022-11-16
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 1. Documented or self-reported positive test for COVID-19 ≥4 weeks prior to enrollment.
2. No fever for ≥4 weeks prior to enrollment.
3. Reports fatigue and/or brain fog (i.e. concentration or memory impairment) for ≥4 weeks prior to enrollment on the PASC-Specific Symptom questionnaire beginning after infection with COVID-19.
4. Fatigue Severity Scale (FSS) score ≥28 or Brain Fog Severity Scale (BFSS) score ≥28 at baseline.
5. Beck Depression Inventory II score \<24.
6. No change in any psychoactive or steroid medications for ≥30 days.
7. No plan to change any psychoactive, steroid or diuretic medication for ≥5 weeks and not planning on obtaining a COVID vaccine within the next 5 weeks.
8. Not using any long COVID therapies felt to be worsening the patient's symptoms or starting a long COVID therapy within the next 5 weeks.
9. No history of fibromyalgia, chronic fatigue syndrome or progressive cognitive disorder prior to COVID-19 infection.
10. No active medical, psychiatric or social problems that would interfere with completing the study procedures in the opinion of the investigator.
11. No use of tobacco or marijuana products for \>6 months and no current alcohol abuse (≥4 drinks/day) or illicit drug use.
12. Not receiving or applying for disability payments or workman's compensation for long COVID.
13. Not pregnant or nursing or planning to get pregnant over the next two months.

Primary outcomes:
measure: Fatigue Severity Scale
timeFrame: Change from baseline to day 21
measure: Brain Fog Severity Scale
timeFrame: Change from baseline to day 21
Secondary outcomes:
measure: Patient Global Impression of Change (PGIC)
timeFrame: Day 21
measure: Well-Being Scale
timeFrame: Change from baseline to day 21
measure: Short Form-12 Health Survey (1-week Modification)
timeFrame: Change from baseline to day 21
measure: Desire to Continue Therapy
timeFrame: Day 21
measure: Generalized Anxiety Disorder-2 Scale
timeFrame: Change from baseline to day 21
measure: Headache and Body Pain Bother Scale
timeFrame: Change from baseline to day 21
measure: Insomnia Severity Index
timeFrame: Change from baseline to day 21
measure: Sense of Smell and Taste Change Scale
timeFrame: Day 21
measure: Digit Symbol Substitution Test
timeFrame: Change from baseline to day 21
measure: Delayed Recall Test
timeFrame: Change from baseline to day 21
Other outcomes:
Locations:
city: Williamsville
country: United States
facility: University at Buffalo
state: New York
Study officials:
affiliation: University at Buffalo
name: Thomas Guttuso, Jr., MD
role: PRINCIPAL_INVESTIGATOR
References: