Lithium Long COVID Dose-finding Study

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

Study Overview

• Status: Recruiting
• Conditions: Long COVID
• Intervention / Treatment: Dietary supplement: Lithium

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Rachel Shepherd, NP; Phone Number: 716-932-6080; Email: rlaporta@buffalo.edu
• Study Contact Backup: Name: Thomas Guttuso, MD

Study Locations

• United States
  • New York
    • Williamsville, New York, United States, 14221
      • Recruiting
      • UBMD Neurology
      • Contact: Amelia Cheney; Email: acheney4@buffalo.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lithium; Lithium capsules titrated to 30-45mg/day based on individual patient subjective benefits and tolerability.	Dietary supplement: Lithium; Elemental lithium as lithium aspartate.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: State University of New York at Buffalo

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2023
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: October 26, 2023
• First Submitted That Met QC Criteria: October 27, 2023
• First Posted (Actual): October 31, 2023

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; Chronic Disease; Post-Infectious Disorders; COVID-19; Post-Acute COVID-19 Syndrome; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Enzyme Inhibitors; Tranquilizing Agents; Psychotropic Drugs; Antidepressive Agents; Antimanic Agents; Lithium Carbonate
• Other Study ID Numbers: STUDY00007796

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No