Long COVIDPhase 1NCT06108297
Lithium Long COVID Dose-finding Study
A Phase 1 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 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. 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?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Oct 2023to 2 May 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
Who may be able to join
- Enrolled from November 2022-July 2023 in lithium long COVID clinical trial at UB.
- Reports bothersome fatigue and/or brain fog while not taking lithium or, reports satisfactory benefit to these symptoms while taking lithium.
- 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.
- 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.
Who cannot join
- Fever or signs of acute infection in last 4 weeks.
- COVID vaccine administered within 4 weeks. No change in any psychoactive or steroid medications for ≥30 days.
- Plan to change a psychoactive, steroid or diuretic medication in next 5 weeks.
- History of heart attack or stroke within the previous year.
- Active medical, psychiatric or social problem that would interfere with completing the study procedures in the opinion of the investigator.
- Daily NSAID use.
- Pregnant or nursing or planning to get pregnant over the next 11 weeks.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Low-dose Lithium Therapy on Long COVID Symptoms: an Open-label, Dose-finding Study.
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.
- Conditions
- Long COVID
- Being tested
- Lithium
- 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.
LithiumDietary supplement
Elemental lithium as lithium aspartate.
| Study group | Role | What they receive |
|---|---|---|
| Lithium | Experimental | Lithium capsules titrated to 30-45mg/day based on individual patient subjective benefits and tolerability. Receives: Dietary Supplement: Lithium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue Severity Scale (FSS)
7-item scale. Score range 1-49 with higher values signifying worse outcome
Measured: Baseline to end-of-titration (up to 11 weeks)
Brain Fog Severity Scale (BFSS)
7-item scale. Score range 1-49 with higher values signifying worse outcome
Measured: Baseline to end-of-titration (up to 11 weeks)
Secondary outcomes (12)
Well Being Scale
Single-item question. Score range 0-10 with higher values signifying better outcome.
Measured: Baseline to end-of-titration (up to 11 weeks)
Short Form-12 Health Survey
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: Baseline to end-of-titration (up to 11 weeks)
FSS scores in those with FSS score ≥28 at baseline
7-item scale. Score range 1-49 with higher values signifying worse outcome
Measured: Baseline to end-of-titration (up to 11 weeks)
BFSS scores in those with FSS score ≥28 at baseline
7-item scale. Score range 1-49 with higher values signifying worse outcome
Measured: Baseline to end-of-titration (up to 11 weeks)
Modified Fatigue Impact Scale
21-item scale. Score range 0-84 with higher values signifying worse outcome
Measured: Baseline to end-of-titration (up to 11 weeks)
Perceived Deficits Questionnaire, 5-Item Version
5-item scale. Score range 1-20 with higher values signifying worse outcome
Measured: Baseline to end-of-titration (up to 11 weeks)
Beck Depression Inventory-II
21-item scale. Score range 0-63 with higher values signifying worse outcome
Measured: Baseline to end-of-titration (up to 11 weeks)
Generalized Anxiety Disorder Scale-2
2-item scale. Score range 0-6 with higher values signifying worse outcome
Measured: Baseline to end-of-titration (up to 11 weeks)
Headache and Body Pain Bother Scale
2-item scale. Score range 2-10 with higher values signifying worse outcome
Measured: Baseline to end-of-titration (up to 11 weeks)
Insomnia Severity Index
7-item scale. Score range 0-28 with higher values signifying worse outcome
Measured: Baseline to end-of-titration (up to 11 weeks)
Patient Global Impression of Change
Single-item scale. Score range 1-7 with higher values signifying better outcome
Measured: End-of-titration (up to 11 weeks)
Desire to Continue Therapy Scale
Single-item scale. Score range 1-2 with higher value signifying better outcome
Measured: End-of-titration (up to 11 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start12 Oct 2023
- Primary completion26 Mar 2024
- Study completion2 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Guttuso, State University of New York at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06108297
- Sponsor's protocol ID
- STUDY00007796
- Status last verified
- Oct 2024
- First submitted
- 26 Oct 2023
- Last updated
- 22 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 22 Oct 2024. 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: an Open-label, Dose-finding Study.
- ClinicalTrials.gov ID
- NCT06108297
- Acronym / sponsor ID
- STUDY00007796
- Conditions
- Long COVID
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- 12 Oct 2023 (actual)
- Primary completion
- 26 Mar 2024 (actual)
- Study completion
- 2 May 2024 (actual)
- First posted
- 31 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lithium | Experimental | Dietary Supplement: LithiumLithium capsules titrated to 30-45mg/day based on individual patient subjective benefits and tolerability. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Enrolled from November 2022-July 2023 in lithium long COVID clinical trial at UB.
- Reports bothersome fatigue and/or brain fog while not taking lithium or, reports satisfactory benefit to these symptoms while taking lithium.
- 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.
- 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.
Key exclusion criteria (7 listed)
- Fever or signs of acute infection in last 4 weeks.
- COVID vaccine administered within 4 weeks. No change in any psychoactive or steroid medications for ≥30 days.
- Plan to change a psychoactive, steroid or diuretic medication in next 5 weeks.
- History of heart attack or stroke within the previous year.
- Active medical, psychiatric or social problem that would interfere with completing the study procedures in the opinion of the investigator.
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 |
|---|---|---|
| LithiumElemental lithium as lithium aspartate. | Dietary supplement | Lithium |
Primary outcome
Fatigue Severity Scale (FSS)
Time frame: Baseline to end-of-titration (up to 11 weeks)
7-item scale. Score range 1-49 with higher values signifying worse outcome
Brain Fog Severity Scale (BFSS)
Time frame: Baseline to end-of-titration (up to 11 weeks)
7-item scale. Score range 1-49 with higher values signifying worse outcome
12 secondary outcomes
Well Being Scale
Time frame: Baseline to end-of-titration (up to 11 weeks)
Short Form-12 Health Survey
Time frame: Baseline to end-of-titration (up to 11 weeks)
FSS scores in those with FSS score ≥28 at baseline
Time frame: Baseline to end-of-titration (up to 11 weeks)
BFSS scores in those with FSS score ≥28 at baseline
Time frame: Baseline to end-of-titration (up to 11 weeks)
Modified Fatigue Impact Scale
Time frame: Baseline to end-of-titration (up to 11 weeks)
Perceived Deficits Questionnaire, 5-Item Version
Time frame: Baseline to end-of-titration (up to 11 weeks)
Beck Depression Inventory-II
Time frame: Baseline to end-of-titration (up to 11 weeks)
Generalized Anxiety Disorder Scale-2
Time frame: Baseline to end-of-titration (up to 11 weeks)
Headache and Body Pain Bother Scale
Time frame: Baseline to end-of-titration (up to 11 weeks)
Insomnia Severity Index
Time frame: Baseline to end-of-titration (up to 11 weeks)
Patient Global Impression of Change
Time frame: End-of-titration (up to 11 weeks)
Desire to Continue Therapy Scale
Time frame: End-of-titration (up to 11 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2024.
- 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.
- Individual participant dataSharing planned: Undecided
Related trials for Long COVID
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Not yet recruitingPhase 3
Dapagliflozin for Long COVID Syndrome
COVID - 19, Long COVID Syndrome
Active, not recruiting
Long COVID Brain Fog: Cognitive Rehabilitation Trial
Long COVID, Brain Fog
RecruitingPhase 2
SARS-CoV-2 and Herpesvirus Inhibition for Ending Long COVID Dysfunction
Post-acute Sequelae of COVID-19, Long COVID
Enrolling by invitation
Fareon Open Label Device Clinical Trial
Cognitive Dysfunction, Acquired Brain Injury
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 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?
The sponsor lists 4 inclusion and 7 exclusion criteria. 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 22 Oct 2024. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (FSS) (time frame: Baseline to end-of-titration (up to 11 weeks)). 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 NCT06108297, 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 22 Oct 2024.