Effect of Lithium Therapy on Long COVID Symptoms
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05618587|
Recruitment Status : Recruiting
First Posted : November 16, 2022
Last Update Posted : February 14, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Long COVID||Drug: Lithium Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Effect of Low-dose Lithium Therapy on Long COVID Symptoms: a Randomized Controlled Trial.|
|Actual Study Start Date :||November 28, 2022|
|Estimated Primary Completion Date :||May 2023|
|Estimated Study Completion Date :||June 2023|
Lithium 10mg po qd
Lithium has multiple mechanisms of action including anti-inflammatory actions, which may be relevant for treating long COVID.
Placebo Comparator: Placebo
Placebo identically matching the lithium pills
- Fatigue Severity Scale [ Time Frame: Change from baseline to day 21 ]7-item questionnaire assessing fatigue severity
- Brain Fog Severity Scale [ Time Frame: Change from baseline to day 21 ]7-item questionnaire assessing brain fog severity
- Patient Global Impression of Change (PGIC) [ Time Frame: Day 21 ]Change in symptoms on 7-point scale
- Well-Being Scale [ Time Frame: Change from baseline to day 21 ]Sense of well-being over past week on 10-point scale
- Short Form-12 Health Survey (1-week modification) [ Time Frame: Change from baseline to day 21 ]Quality of life assessment over past week
- Desire to Continue Therapy [ Time Frame: Day 21 ]Single Yes/No question
- Generalized Anxiety Disorder-2 Scale [ Time Frame: Change from baseline to day 21 ]2-item questionnaire assessing anxiety frequency over the past week
- Headache and Body Pain Bother Scale [ Time Frame: Change from baseline to day 21 ]2-item questionnaire assessing frequency of headaches and body pain over the past week
- Insomnia Severity Index [ Time Frame: Change from baseline to day 21 ]7-item questionnaire assessing insomnia severity over the past week
- Sense of Smell and Taste Change Scale [ Time Frame: Day 21 ]Subjective change from baseline on a 7-point scale
- Digit Symbol Substitution Test [ Time Frame: Change from baseline to day 21 ]Validated cognitive test
- Delayed Recall Test [ Time Frame: Change from baseline to day 21 ]Validated cognitive test
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 80 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Documented or self-reported positive test for COVID-19 ≥4 weeks prior to enrollment.
- No fever for ≥4 weeks prior to enrollment.
- Reports fatigue and/or brain fog (i.e. concentration or memory impairment) for ≥4 weeks prior to enrollment on the PASC-Specific Symptom questionnaire beginning after infection with COVID-19.
- Fatigue Severity Scale (FSS) score ≥28 or Brain Fog Severity Scale (BFSS) score ≥28 at baseline.
- Beck Depression Inventory II score <24.
- No change in any psychoactive or steroid medications for ≥30 days.
- No plan to change any psychoactive, steroid or diuretic medication for ≥5 weeks and not planning on obtaining a COVID vaccine within the next 5 weeks.
- Not using any long COVID therapies felt to be worsening the patient's symptoms or starting a long COVID therapy within the next 5 weeks.
- No history of fibromyalgia, chronic fatigue syndrome or progressive cognitive disorder prior to COVID-19 infection.
- No active medical, psychiatric or social problems that would interfere with completing the study procedures in the opinion of the investigator.
- No use of tobacco or marijuana products for >6 months and no current alcohol abuse (≥4 drinks/day) or illicit drug use.
- Not receiving or applying for disability payments or workman's compensation for long COVID.
- Not pregnant or nursing or planning to get pregnant over the next two months.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05618587
|Contact: Thomas Guttuso, Jr., MDemail@example.com|
|Contact: Rachel Shepherd, NP|
|United States, New York|
|University at Buffalo||Recruiting|
|Williamsville, New York, United States, 14221|
|Contact: Thomas Guttuso, Jr., MD 716-829-5454 firstname.lastname@example.org|
|Principal Investigator:||Thomas Guttuso, Jr., MD||University at Buffalo|
|Responsible Party:||Thomas Guttuso, Professor of Neurology, State University of New York at Buffalo|
|Other Study ID Numbers:||
|First Posted:||November 16, 2022 Key Record Dates|
|Last Update Posted:||February 14, 2023|
|Last Verified:||February 2023|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
lithium, long COVID
Molecular Mechanisms of Pharmacological Action
Central Nervous System Depressants
Physiological Effects of Drugs