Effect of Lithium Therapy on Long COVID Symptoms

Long COVID Clinical Trial

Official title:

Effect of Low-dose Lithium Therapy on Long COVID Symptoms: a Randomized Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05618587
• Other study ID #: STUDY00006678
• Secondary ID: UL1TR001412
• Status: Completed
• Phase: Phase 2
• Start date: November 28, 2022
• Est. completion date: July 21, 2023

Study information

• Verified date: October 2023
• Source: State University of New York at Buffalo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will assess low-dose lithium's effects on several different symptoms experienced by long COVID patients.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 21, 2023
• Est. primary completion date: July 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

1. Documented or self-reported positive test for COVID-19 =4 weeks prior to enrollment.

2. No fever for =4 weeks prior to enrollment.

3. 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.

4. Fatigue Severity Scale (FSS) score =28 or Brain Fog Severity Scale (BFSS) score =28 at baseline.

5. Beck Depression Inventory II score <24.

6. No change in any psychoactive or steroid medications for =30 days.

7. 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.

8. 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.

9. No history of fibromyalgia, chronic fatigue syndrome or progressive cognitive disorder prior to COVID-19 infection.

10. No active medical, psychiatric or social problems that would interfere with completing the study procedures in the opinion of the investigator.

11. No use of tobacco or marijuana products for >6 months and no current alcohol abuse (=4 drinks/day) or illicit drug use.

12. Not receiving or applying for disability payments or workman's compensation for long COVID.

13. Not pregnant or nursing or planning to get pregnant over the next two months.

Related Conditions & MeSH terms

• Long COVID

Intervention

Drug:
• Lithium
Lithium has multiple mechanisms of action including anti-inflammatory actions, which may be relevant for treating long COVID.
• Placebo
Inactive pill

Locations

Country	Name	City	State
United States	University at Buffalo	Williamsville	New York

Sponsors (2)

Lead Sponsor	Collaborator
State University of New York at Buffalo	National Center for Advancing Translational Sciences (NCATS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fatigue Severity Scale	7-item questionnaire assessing fatigue severity	Change from baseline to day 21
Primary	Brain Fog Severity Scale	7-item questionnaire assessing brain fog severity	Change from baseline to day 21
Secondary	Patient Global Impression of Change (PGIC)	Change in symptoms on 7-point scale	Day 21
Secondary	Well-Being Scale	Sense of well-being over past week on 10-point scale	Change from baseline to day 21
Secondary	Short Form-12 Health Survey (1-week modification)	Quality of life assessment over past week	Change from baseline to day 21
Secondary	Desire to Continue Therapy	Single Yes/No question	Day 21
Secondary	Generalized Anxiety Disorder-2 Scale	2-item questionnaire assessing anxiety frequency over the past week	Change from baseline to day 21
Secondary	Headache and Body Pain Bother Scale	2-item questionnaire assessing frequency of headaches and body pain over the past week	Change from baseline to day 21
Secondary	Insomnia Severity Index	7-item questionnaire assessing insomnia severity over the past week	Change from baseline to day 21
Secondary	Sense of Smell and Taste Change Scale	Subjective change from baseline on a 7-point scale	Day 21
Secondary	Digit Symbol Substitution Test	Validated cognitive test	Change from baseline to day 21
Secondary	Delayed Recall Test	Validated cognitive test	Change from baseline to day 21