Lithium Long COVID Dose-finding Study

Phase 1

Completed

• Conditions: Long COVID
• Interventions: Dietary Supplement: Lithium

• Registration Number: NCT06108297
• Lead Sponsor: State University of New York at Buffalo

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-12
• Study First Submitted: 2023-10-26
• Study First Submitted QC: 2023-10-27
• Study First Posted: 2023-10-31
• Primary Completion: 2024-03-26
• Study Completion: 2024-05-02
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-19
• Last Update Posted: 2024-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lithium	Lithium	Lithium capsules titrated to 30-45mg/day based on individual patient subjective benefits and tolerability.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
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
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
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.
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
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
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.
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
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
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

Trial Locations

Locations (1)

UBMD Neurology; 🇺🇸 Williamsville, New York, United States