Lithium Long COVID Dose-finding Study

October 19, 2024 updated by: Thomas Guttuso, State University of New York at Buffalo

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Thomas Guttuso, MD

Study Locations

  • United States
    • New York
      • Williamsville, New York, United States, 14221
        • UBMD Neurology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Baseline to end-of-titration (up to 11 weeks)
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
Baseline to end-of-titration (up to 11 weeks)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Baseline to end-of-titration (up to 11 weeks)
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.
Baseline to end-of-titration (up to 11 weeks)
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
Baseline to end-of-titration (up to 11 weeks)
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
Baseline to end-of-titration (up to 11 weeks)
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
Baseline to end-of-titration (up to 11 weeks)
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
Baseline to end-of-titration (up to 11 weeks)
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
Baseline to end-of-titration (up to 11 weeks)
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
Baseline to end-of-titration (up to 11 weeks)
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
Baseline to end-of-titration (up to 11 weeks)
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
Baseline to end-of-titration (up to 11 weeks)
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
End-of-titration (up to 11 weeks)
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
End-of-titration (up to 11 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
State University of New York at Buffalo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 12, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 26, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 2, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 26, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 27, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 31, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 22, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 19, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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