Lithium Long COVID Dose-finding Study

Long COVID Clinical Trial

Official title:

Effect of Low-dose Lithium Therapy on Long COVID Symptoms: an Open-label, Dose-finding Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06108297
• Other study ID #: STUDY00007796
• Status: Recruiting
• Phase: Phase 1
• Start date: October 12, 2023
• Est. completion date: July 2024

Study information

• Verified date: March 2024
• Source: State University of New York at Buffalo
• Contact: Rachel Shepherd, NP
• Phone: 716-932-6080
• Email: rlaporta[@]buffalo.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: July 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Long COVID

Intervention

Dietary Supplement:
• Lithium
Elemental lithium as lithium aspartate.

Locations

Country	Name	City	State
United States	UBMD Neurology	Williamsville	New York

Sponsors (1)

Lead Sponsor	Collaborator
State University of New York at Buffalo

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fatigue Severity Scale (FSS)	7-item scale. Score range 1-49 with higher values signifying worse outcome	Baseline to end-of-titration (up to 11 weeks)
Primary	Brain Fog Severity Scale (BFSS)	7-item scale. Score range 1-49 with higher values signifying worse outcome	Baseline to end-of-titration (up to 11 weeks)
Secondary	Well Being Scale	Single-item question. Score range 0-10 with higher values signifying better outcome.	Baseline to end-of-titration (up to 11 weeks)
Secondary	Short Form-12 Health Survey	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.	Baseline to end-of-titration (up to 11 weeks)
Secondary	FSS scores in those with FSS score =28 at baseline	7-item scale. Score range 1-49 with higher values signifying worse outcome	Baseline to end-of-titration (up to 11 weeks)
Secondary	BFSS scores in those with FSS score =28 at baseline	7-item scale. Score range 1-49 with higher values signifying worse outcome	Baseline to end-of-titration (up to 11 weeks)
Secondary	Modified Fatigue Impact Scale	21-item scale. Score range 0-84 with higher values signifying worse outcome	Baseline to end-of-titration (up to 11 weeks)
Secondary	Perceived Deficits Questionnaire, 5-Item Version	5-item scale. Score range 1-20 with higher values signifying worse outcome	Baseline to end-of-titration (up to 11 weeks)
Secondary	Beck Depression Inventory-II	21-item scale. Score range 0-63 with higher values signifying worse outcome	Baseline to end-of-titration (up to 11 weeks)
Secondary	Generalized Anxiety Disorder Scale-2	2-item scale. Score range 0-6 with higher values signifying worse outcome	Baseline to end-of-titration (up to 11 weeks)
Secondary	Headache and Body Pain Bother Scale	2-item scale. Score range 2-10 with higher values signifying worse outcome	Baseline to end-of-titration (up to 11 weeks)
Secondary	Insomnia Severity Index	7-item scale. Score range 0-28 with higher values signifying worse outcome	Baseline to end-of-titration (up to 11 weeks)
Secondary	Patient Global Impression of Change	Single-item scale. Score range 1-7 with higher values signifying better outcome	End-of-titration (up to 11 weeks)
Secondary	Desire to Continue Therapy Scale	Single-item scale. Score range 1-2 with higher value signifying better outcome	End-of-titration (up to 11 weeks)