Phase 2 N=52 Randomized Quadruple-blind Treatment

Effect of Lithium Therapy on Long COVID Symptoms

Long COVID

Bottom Line

View on ClinicalTrials.gov: NCT05618587 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2025

Primary outcome: Primary: Fatigue Severity Scale — -11.3; -8.6 score on a scale — p=0.46

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Lithium (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: State University of New York at Buffalo
Primary completion: Jul 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Fatigue Severity Scale	-11.3; -8.6	0.46
PRIMARY Brain Fog Severity Scale	-9.0; -8.1	0.79
SECONDARY Patient Global Impression of Change (PGIC)	4.7; 4.6	0.68
SECONDARY Well-Being Scale	1.0; 0.9	0.89
SECONDARY Short Form-12 Health Survey (1-week Modification)	5.1; 4.2	0.75
SECONDARY Desire to Continue Therapy	12; 13	1.0
SECONDARY Generalized Anxiety Disorder-2 Scale	-0.8; -1.4	0.28
SECONDARY Headache and Body Pain Bother Scale	-0.6; -0.7	0.58
SECONDARY Insomnia Severity Index	-6.0; -4.4	0.41
SECONDARY Sense of Smell and Taste Change Scale	4.1; 4.2	0.50
SECONDARY Digit Symbol Substitution Test	4.3; 6.6	0.29
SECONDARY Delayed Recall Test	0.46; 0.35	0.35

Summary

This study will assess low-dose lithium's effects on several different symptoms experienced by long COVID patients.

Eligibility Criteria

Documented or self-reported positive test for COVID-19 ≥4 weeks prior to enrollment.
No fever for ≥4 weeks prior to enrollment.
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.
Fatigue Severity Scale (FSS) score ≥28 or Brain Fog Severity Scale (BFSS) score ≥28 at baseline.
Beck Depression Inventory II score 6 months and no current alcohol abuse (≥4 drinks/day) or illicit drug use.
Not receiving or applying for disability payments or workman's compensation for long COVID.
Not pregnant or nursing or planning to get pregnant over the next two months.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05618587). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.