Lithium Long COVID Dose-finding Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-12

Study Completion Date

2024-05-02

Brief Summary

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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.

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Detailed Description

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Conditions

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Long COVID

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lithium

Lithium capsules titrated to 30-45mg/day based on individual patient subjective benefits and tolerability.

Group Type EXPERIMENTAL

Lithium

Intervention Type DIETARY_SUPPLEMENT

Elemental lithium as lithium aspartate.

Interventions

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Lithium

Elemental lithium as lithium aspartate.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No