Long COVIDPhase 2NCT05618587
Effect of Lithium Therapy on Long COVID Symptoms
A Phase 2 study testing Lithium in people with Long COVID, run by State University of New York at Buffalo at 1 site in United States.
Trial summary
This study will assess low-dose lithium's effects on several different symptoms experienced by long COVID patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Long COVID
- What is being tested?
- Lithium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Nov 2022to 21 Jul 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University at Buffalo
Williamsville, New York, 14221
About this study
Official title: Effect of Low-dose Lithium Therapy on Long COVID Symptoms: a Randomized Controlled Trial.
This study will assess low-dose lithium's effects on several different symptoms experienced by long COVID patients.
Read the detailed description
In this double-blind, placebo-controlled study, 50 patients with long COVID will be randomly assigned to either low-dose oral lithium or placebo therapy for three weeks. After the double-blind study phase, all patients will be provided with lithium therapy for two additional weeks. Study visits will occur at baseline and after the three-week double-blind study phase.
- Conditions
- Long COVID
- Being tested
- Lithium, Placebo
- Keywords
- lithium, long COVID
- Medical subject headings
- Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LithiumDrug
Lithium has multiple mechanisms of action including anti-inflammatory actions, which may be relevant for treating long COVID.
PlaceboDrug
Inactive pill
| Study group | Role | What they receive |
|---|---|---|
| Lithium | Experimental | Lithium 10mg po qd Receives: Drug: Lithium |
| Placebo | Placebo comparator | Placebo identically matching the lithium pills Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue Severity Scale
7-item questionnaire assessing fatigue severity. Score range 1-49 with higher values signifying worse outcome
Measured: Change from baseline to day 21
Brain Fog Severity Scale
7-item questionnaire assessing brain fog severity. Score range 1-49 with higher values signifying worse outcome
Measured: Change from baseline to day 21
Secondary outcomes (10)
Patient Global Impression of Change (PGIC)
Change in symptoms on 7-point scale. Single-item scale. Score range 1-7 with higher values signifying better outcome
Measured: Day 21
Well-Being Scale
Sense of well-being over past week on 10-point scale. Score range 0-10 with higher values signifying better outcome.
Measured: Change from baseline to day 21
Short Form-12 Health Survey (1-week Modification)
Quality of life assessment over past week, PCS-subscale. 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.
Measured: Change from baseline to day 21
Desire to Continue Therapy
Single Yes/No question. Single-item scale. Score range 1-2 with higher value signifying better outcome. Reported as % of respondents recording "yes".
Measured: Day 21
Generalized Anxiety Disorder-2 Scale
2-item questionnaire assessing anxiety frequency over the past week. 2-item scale. Score range 0-6 with higher values signifying worse outcome
Measured: Change from baseline to day 21
Headache and Body Pain Bother Scale
2-item questionnaire assessing frequency of headaches and body pain over the past week, Headache score. 2-item scale. Score range 2-10 with higher values signifying worse outcome
Measured: Change from baseline to day 21
Insomnia Severity Index
7-item questionnaire assessing insomnia severity over the past week. 7-item scale. Score range 0-28 with higher values signifying worse outcome.
Measured: Change from baseline to day 21
Sense of Smell and Taste Change Scale
Subjective change from baseline on a 7-point scale (score range: 1-7) with higher scores indicating better outcomes. Scores of 1 and 7 indicate sense of smell and taste were "very much worse" or "very much improved", respectively, since the start of study treatment.
Measured: Day 21
Digit Symbol Substitution Test
Validated cognitive test. Score range 0-100 with higher scores indicating a better outcome.
Measured: Change from baseline to day 21
Delayed Recall Test
Validated cognitive test. Score range 0-5 with higher scores indicating better outcomes.
Measured: Change from baseline to day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2022
- Study start28 Nov 2022
- Primary completion21 Jul 2023
- Study completion21 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Long COVIDStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Principal investigator, Thomas Guttuso, State University of New York at Buffalo
- Investigators
- Thomas Guttuso, Jr., MD, Principal investigator, University at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05618587
- Sponsor's protocol ID
- STUDY00006678
- Other IDs
- UL1TR001412
- Status last verified
- Feb 2025
- First submitted
- 14 Nov 2022
- Last updated
- 5 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Guttuso T Jr, Zhu J, Wilding GE. Lithium Aspartate for Long COVID Fatigue and Cognitive Dysfunction: A Randomized Clinical Trial. JAMA Netw Open. 2024 Oct 1;7(10):e2436874. doi: 10.1001/jamanetworkopen.2024.36874.
PubMed 39356507
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low-dose Lithium Therapy on Long COVID Symptoms: a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT05618587
- Acronym / sponsor ID
- STUDY00006678
- Conditions
- Long COVID
- Keywords
- lithium, long COVID
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 28 Nov 2022 (actual)
- Primary completion
- 21 Jul 2023 (actual)
- Study completion
- 21 Jul 2023 (actual)
- First posted
- 16 Nov 2022 (actual)
- Results
- Posted 5 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess low-dose lithium's effects on several different symptoms experienced by long COVID patients.
Detailed description
In this double-blind, placebo-controlled study, 50 patients with long COVID will be randomly assigned to either low-dose oral lithium or placebo therapy for three weeks. After the double-blind study phase, all patients will be provided with lithium therapy for two additional weeks. Study visits will occur at baseline and after the three-week double-blind study phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lithium | Experimental | Drug: LithiumLithium 10mg po qd |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo identically matching the lithium pills |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LithiumLithium has multiple mechanisms of action including anti-inflammatory actions, which may be relevant for treating long COVID. | Drug | Lithium |
| PlaceboInactive pill | Drug | Placebo |
Primary outcome
Fatigue Severity Scale
Time frame: Change from baseline to day 21
7-item questionnaire assessing fatigue severity. Score range 1-49 with higher values signifying worse outcome
Brain Fog Severity Scale
Time frame: Change from baseline to day 21
7-item questionnaire assessing brain fog severity. Score range 1-49 with higher values signifying worse outcome
10 secondary outcomes
Patient Global Impression of Change (PGIC)
Time frame: Day 21
Well-Being Scale
Time frame: Change from baseline to day 21
Short Form-12 Health Survey (1-week Modification)
Time frame: Change from baseline to day 21
Desire to Continue Therapy
Time frame: Day 21
Generalized Anxiety Disorder-2 Scale
Time frame: Change from baseline to day 21
Headache and Body Pain Bother Scale
Time frame: Change from baseline to day 21
Insomnia Severity Index
Time frame: Change from baseline to day 21
Sense of Smell and Taste Change Scale
Time frame: Day 21
Digit Symbol Substitution Test
Time frame: Change from baseline to day 21
Delayed Recall Test
Time frame: Change from baseline to day 21
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39356507Guttuso T Jr, Zhu J, Wilding GE. Lithium Aspartate for Long COVID Fatigue and Cognitive Dysfunction: A Randomized Clinical Trial. JAMA Netw Open. 2024 Oct 1;7(10):e2436874. doi: 10.1001/jamanetworkopen.2024.36874.
Related trials for Long COVID
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Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Not yet recruitingPhase 3
The Study of Brave-LC LDN Treatment Trial
Post-acute COVID-19 Syndrome
Active, not recruitingObservational study
Epigenetic Changes in Long COVID Patients
Long COVID-19 Syndrome, Long COVID Symptoms
Enrolling by invitationPhase 2
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Systemic Inflammation, Neuroinflammation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Guttuso, Jr., MD principal investigator
University at Buffalo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lithium in people with Long COVID, run by State University of New York at Buffalo at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue Severity Scale (time frame: Change from baseline to day 21). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05618587, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2025.