Effect of Lithium Therapy on Long COVID Symptoms

NCT05618587 | Completed Phase 2 Results

• 2 other identifiers: STUDY00006678UL1TR001412
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Long COVID

Keywords

lithium, long COVID

Outcome Measures

Primary Outcomes (2)

• Fatigue Severity Scale

  7-item questionnaire assessing fatigue severity. Score range 1-49 with higher values signifying worse outcome

  Change from baseline to day 21

• Brain Fog Severity Scale

  7-item questionnaire assessing brain fog severity. Score range 1-49 with higher values signifying worse outcome

  Change from baseline to day 21

Secondary Outcomes (10)

• Patient Global Impression of Change (PGIC)

  Day 21

• Well-Being Scale

  Change from baseline to day 21

• Short Form-12 Health Survey (1-week Modification)

  Change from baseline to day 21

• Desire to Continue Therapy

  Day 21

• Generalized Anxiety Disorder-2 Scale

  Change from baseline to day 21

Study Arms (2)

Lithium

EXPERIMENTAL

Lithium 10mg po qd

Drug: Lithium

Placebo

PLACEBO COMPARATOR

Placebo identically matching the lithium pills

Drug: Placebo

Interventions

Lithium DRUG

Lithium has multiple mechanisms of action including anti-inflammatory actions, which may be relevant for treating long COVID.

Lithium

Placebo DRUG

Inactive pill

Placebo

Eligibility Criteria

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

1. Documented or self-reported positive test for COVID-19 ≥4 weeks prior to enrollment. 2. No fever for ≥4 weeks prior to enrollment. 3. 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. 4. Fatigue Severity Scale (FSS) score ≥28 or Brain Fog Severity Scale (BFSS) score ≥28 at baseline. 5. Beck Depression Inventory II score \<24. 6. No change in any psychoactive or steroid medications for ≥30 days. 7. No plan to change any psychoactive, steroid or diuretic medication for ≥5 weeks and not planning on obtaining a COVID vaccine within the next 5 weeks. 8. Not using any long COVID therapies felt to be worsening the patient's symptoms or starting a long COVID therapy within the next 5 weeks. 9. No history of fibromyalgia, chronic fatigue syndrome or progressive cognitive disorder prior to COVID-19 infection. 10. No active medical, psychiatric or social problems that would interfere with completing the study procedures in the opinion of the investigator. 11. No use of tobacco or marijuana products for \>6 months and no current alcohol abuse (≥4 drinks/day) or illicit drug use. 12. Not receiving or applying for disability payments or workman's compensation for long COVID. 13. Not pregnant or nursing or planning to get pregnant over the next two months.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• State University of New York at Buffalo: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

University at Buffalo

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

Results Point of Contact

• Title: Thomas Guttuso, Jr., MD
• Organization: University at Buffalo

tguttuso@buffalo.edu

716-932-6080

Study Officials

• Thomas Guttuso, Jr., MD

  University at Buffalo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology

Study Record Dates

• First Submitted: November 14, 2022
• First Posted: November 16, 2022
• Study Start: November 28, 2022
• Primary Completion: July 21, 2023
• Study Completion: July 21, 2023
• Last Updated: March 5, 2025
• Results First Posted: March 5, 2025

Record last verified: 2025-02

Locations

US (1)