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Lithium Long COVID Dose-finding Study

Lithium Long COVID Dose-finding Study

Non Recruiting
18-80 years
All
Phase 1

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Overview

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.

Eligibility

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 details
    Long COVID

NCT06108297

State University of New York at Buffalo

20 August 2025

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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