Skip to main content
OpenTrials
Completed

NCT Number: NCT06108297

Lithium Long COVID Dose-finding Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

UBMD Neurology

Williamsville, New York, 14221, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Lithium

Dietary Supplement

Elemental lithium as lithium aspartate.

Primary outcomes

  1. Fatigue Severity Scale (FSS)

    Time frame: Baseline to end-of-titration (up to 11 weeks)

    7-item scale. Score range 1-49 with higher values signifying worse outcome

  2. Brain Fog Severity Scale (BFSS)

    Time frame: Baseline to end-of-titration (up to 11 weeks)

    7-item scale. Score range 1-49 with higher values signifying worse outcome

Secondary outcomes

  1. Well Being Scale

    Time frame: Baseline to end-of-titration (up to 11 weeks)

    Single-item question. Score range 0-10 with higher values signifying better outcome.

  2. Short Form-12 Health Survey

    Time frame: 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.

  3. FSS scores in those with FSS score ≥28 at baseline

    Time frame: Baseline to end-of-titration (up to 11 weeks)

    7-item scale. Score range 1-49 with higher values signifying worse outcome

  4. BFSS scores in those with FSS score ≥28 at baseline

    Time frame: Baseline to end-of-titration (up to 11 weeks)

    7-item scale. Score range 1-49 with higher values signifying worse outcome

  5. Modified Fatigue Impact Scale

    Time frame: Baseline to end-of-titration (up to 11 weeks)

    21-item scale. Score range 0-84 with higher values signifying worse outcome

  6. Perceived Deficits Questionnaire, 5-Item Version

    Time frame: Baseline to end-of-titration (up to 11 weeks)

    5-item scale. Score range 1-20 with higher values signifying worse outcome

  7. Beck Depression Inventory-II

    Time frame: Baseline to end-of-titration (up to 11 weeks)

    21-item scale. Score range 0-63 with higher values signifying worse outcome

  8. Generalized Anxiety Disorder Scale-2

    Time frame: Baseline to end-of-titration (up to 11 weeks)

    2-item scale. Score range 0-6 with higher values signifying worse outcome

  9. Headache and Body Pain Bother Scale

    Time frame: Baseline to end-of-titration (up to 11 weeks)

    2-item scale. Score range 2-10 with higher values signifying worse outcome

  10. Insomnia Severity Index

    Time frame: Baseline to end-of-titration (up to 11 weeks)

    7-item scale. Score range 0-28 with higher values signifying worse outcome

  11. Patient Global Impression of Change

    Time frame: End-of-titration (up to 11 weeks)

    Single-item scale. Score range 1-7 with higher values signifying better outcome

  12. Desire to Continue Therapy Scale

    Time frame: End-of-titration (up to 11 weeks)

    Single-item scale. Score range 1-2 with higher value signifying better outcome

Sponsors and collaborators

Lead sponsor

State University of New York at Buffalo

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 31, 2023
Registry last updated
Oct 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.