NCT06108297CompletedPhase 1
Lithium Long COVID Dose-finding Study
Effect of Low-dose Lithium Therapy on Long COVID Symptoms: an Open-label, Dose-finding Study.
Source: ClinicalTrials.gov · Last updated 22 Oct 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 5 (actual)
- First submitted
- 26 Oct 2023
- Start date
- 12 Oct 2023
- Primary completion date
- 26 Mar 2024
- Lead sponsor
- State University of New York at Buffalo
- Diseases
- Long COVID and ME/CFS
- NCT number
- NCT06108297
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 5
- From 12 Oct 2023 to the primary completion date, 26 Mar 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Plan to change a psychoactive, steroid or diuretic medication in next 5 weeks.
- History of heart attack or stroke within the previous year.
Other illness
- 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.
- Active medical, psychiatric or social problem that would interfere with completing the study procedures in the opinion of the investigator.
Other
- Daily NSAID use.
- Pregnant or nursing or planning to get pregnant over the next 11 weeks.
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UBMD Neurology Coordinator of this site? Confirm its status | Williamsville | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.