Effect of Lithium Therapy on Long COVID Symptoms

• Sponsor: University at Buffalo (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05618587
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 6.1
• Patients Per Site Per Month: 8.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Long COVID	Drug: Lithium; Drug: Placebo	Phase 2

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

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effect of Low-dose Lithium Therapy on Long COVID Symptoms: a Randomized Controlled Trial.
• Actual Study Start Date: Nov 28, 2022
• Anticipated Primary Completion Date: May 1, 2023
• Anticipated Study Completion Date: Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lithium Lithium 10mg po qd	Drug: Lithium; 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	Drug: Placebo; Inactive pill

Outcome Measures

Primary Outcome Measures

1. Fatigue Severity Scale [Change from baseline to day 21]

   7-item questionnaire assessing fatigue severity

2. Brain Fog Severity Scale [Change from baseline to day 21]

   7-item questionnaire assessing brain fog severity

Secondary Outcome Measures

1. Patient Global Impression of Change (PGIC) [Day 21]

   Change in symptoms on 7-point scale

2. Well-Being Scale [Change from baseline to day 21]

   Sense of well-being over past week on 10-point scale

3. Short Form-12 Health Survey (1-week modification) [Change from baseline to day 21]

   Quality of life assessment over past week

4. Desire to Continue Therapy [Day 21]

   Single Yes/No question

5. Generalized Anxiety Disorder-2 Scale [Change from baseline to day 21]

   2-item questionnaire assessing anxiety frequency over the past week

6. Headache and Body Pain Bother Scale [Change from baseline to day 21]

   2-item questionnaire assessing frequency of headaches and body pain over the past week

7. Insomnia Severity Index [Change from baseline to day 21]

   7-item questionnaire assessing insomnia severity over the past week

8. Sense of Smell and Taste Change Scale [Day 21]

   Subjective change from baseline on a 7-point scale

9. Digit Symbol Substitution Test [Change from baseline to day 21]

   Validated cognitive test

10. Delayed Recall Test [Change from baseline to day 21]

    Validated cognitive test

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University at Buffalo	Williamsville	New York	United States	14221

Sponsors and Collaborators

• University at Buffalo

Investigators

• Principal Investigator: Thomas Guttuso, Jr., MD, University at Buffalo

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Thomas Guttuso, Professor of Neurology, University at Buffalo
• ClinicalTrials.gov Identifier: NCT05618587
• Other Study ID Numbers: STUDY00006678
• First Posted: Nov 16, 2022
• Last Update Posted: Jan 12, 2023
• Last Verified: Jan 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Thomas Guttuso, Professor of Neurology, University at Buffalo: lithium, long COVID
• Additional relevant MeSH terms: Lithium Carbonate

Study Results

No Results Posted as of Jan 12, 2023