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Lithium for COVID-19

Phase 1

Recruiting

Research Sponsored by State University of New York at Buffalo

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up end-of-titration (up to 11 weeks)

Awards & highlights

Study Summary

"This trial will see if higher doses of lithium (30-45mg/day) can help improve symptoms in patients with long COVID compared to lower doses (10-15mg/day) that were previously studied

Who is the study for?

This trial is for individuals experiencing persistent fatigue or brain fog after COVID-19, who haven't found relief with placebo treatments. Participants must have specific scores on the Fatigue Severity Scale or Brain Fog Severity Scale to qualify and should not be currently taking lithium. Enrollment is open from November 2022 to July 2023.Check my eligibility

What is being tested?

The study is testing whether low doses of lithium (30-45mg/day) are more effective than even lower doses (10-15mg/day) in alleviating long-term symptoms like fatigue and brain fog in patients recovering from COVID-19.See study design

What are the potential side effects?

While the summary doesn't specify side effects, common ones associated with lithium at therapeutic levels include thirst, increased urination, shakiness of hands, and gastrointestinal discomfort.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ end-of-titration (up to 11 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~end-of-titration (up to 11 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and end-of-titration (up to 11 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Brain Fog Severity Scale (BFSS)

Fatigue Severity Scale (FSS)

Secondary outcome measures

BFSS scores in those with FSS score ≥28 at baseline

Beck Depression Inventory-II

Desire to Continue Therapy Scale

+9 more

Side effects data

From 2012 Phase 4 trial • 46 Patients • NCT00596622

33%

headaches

11%

Drymouth

11%

dizziness

11%

Increased appetite

11%

heart palpitations

bad taste

blurred vision

forgetfulness

100%

80%

60%

40%

20%

Study treatment Arm

Bipolar Participants Treated

Trial Design

1Treatment groups

Experimental Treatment

Group I: LithiumExperimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lithium

2001

Completed Phase 4

~2470

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

State University of New York at BuffaloLead Sponsor

247 Previous Clinical Trials

49,492 Total Patients Enrolled

3 Trials studying COVID-19

61 Patients Enrolled for COVID-19

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of individuals receiving medical care as part of this research study?

"Indeed, the information on clinicaltrials.gov reveals that this medical investigation is actively seeking eligible individuals. The trial was first shared on October 12th, 2023, with the most recent update made on March 11th, 2024. Enrollment is set at admitting a total of 40 patients from one designated site."

Answered by AI

Is the recruitment for this research study presently ongoing?

"As per the details available on clinicaltrials.gov, this study is currently in the recruitment phase. The trial was initially listed on 12th October 2023 and most recently updated on 11th March 2024."

Answered by AI

Are individuals aged 60 and above eligible for participation in this study?

"Individuals aged between 18 and 80 are eligible to participate in this research project. There are separate clinical trials available for those under 18 years old (10 trials) and individuals over the age of 65 (118 trials)."

Answered by AI

What are the main goals being pursued in this clinical research?

"This clinical study aims to assess changes in the Brain Fog Severity Scale (BFSS) from baseline to end-of-titration, which spans up to 11 weeks. Additional measures will include the Modified Fatigue Impact Scale, a 21-item assessment with scores ranging from 0-84 where higher values indicate greater impact of fatigue; the Well Being Scale, a single-item query scoring between 0-10 with higher values indicating improved well-being; and the Insomnia Severity Index, comprising a 7-item scale with scores ranging from 0-28 denoting increased severity of insomnia as values rise."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Lithium Long COVID Dose-finding Study

Thomas Guttuso 2023. "Lithium Long COVID Dose-finding Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06108297.

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