Lithium Long COVID Dose-finding Study

NCT06108297 | Completed Phase 1

• 1 other identifier: STUDY00007796
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Long COVID

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (12)

• Well Being Scale

  Baseline to end-of-titration (up to 11 weeks)

• Short Form-12 Health Survey

  Baseline to end-of-titration (up to 11 weeks)

• FSS scores in those with FSS score ≥28 at baseline

  Baseline to end-of-titration (up to 11 weeks)

• BFSS scores in those with FSS score ≥28 at baseline

  Baseline to end-of-titration (up to 11 weeks)

• Modified Fatigue Impact Scale

  Baseline to end-of-titration (up to 11 weeks)

Study Arms (1)

Lithium

EXPERIMENTAL

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

Dietary Supplement: Lithium

Interventions

Lithium DIETARY_SUPPLEMENT

Elemental lithium as lithium aspartate.

Lithium

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Enrolled from November 2022-July 2023 in lithium long COVID clinical trial at UB.
• Reports bothersome fatigue and/or brain fog while not taking lithium or, reports satisfactory benefit to these symptoms while taking lithium.
• 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.
• 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.

You may not qualify if:

• Fever or signs of acute infection in last 4 weeks.
• COVID vaccine administered within 4 weeks. No change in any psychoactive or steroid medications for ≥30 days.
• Plan to change a psychoactive, steroid or diuretic medication in next 5 weeks.
• History of heart attack or stroke within the previous year.
• Active medical, psychiatric or social problem that would interfere with completing the study procedures in the opinion of the investigator.
• Daily NSAID use.
• Pregnant or nursing or planning to get pregnant over the next 11 weeks.

Sponsors & Collaborators

• State University of New York at Buffalo: lead

Study Sites (1)

UBMD Neurology

Williamsville, New York, 14221, United States

Location

Related Publications (1)

• Guttuso T Jr, Zhu J, Wilding GE. Lithium Aspartate for Long COVID Fatigue and Cognitive Dysfunction: A Randomized Clinical Trial. JAMA Netw Open. 2024 Oct 1;7(10):e2436874. doi: 10.1001/jamanetworkopen.2024.36874.

  PMID: 39356507 DERIVED

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Interventions

Lithium

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Metals, Alkali; Elements; Inorganic Chemicals; Metals, Light; Metals

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology

Study Record Dates

• First Submitted: October 26, 2023
• First Posted: October 31, 2023
• Study Start: October 12, 2023
• Primary Completion: March 26, 2024
• Study Completion: May 2, 2024
• Last Updated: October 22, 2024

Record last verified: 2024-10

Locations

US (1)