Effect of Lithium Therapy on Long COVID Symptoms

• ClinicalTrials.gov Identifier: NCT05618587
• Recruitment Status: Recruiting
• First Posted: November 16, 2022
• Last Update Posted: February 14, 2023
• Sponsor: State University of New York at Buffalo
• Information provided by (Responsible Party): Thomas Guttuso, State University of New York at Buffalo

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 (Clinical Trial)
• Estimated 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: November 28, 2022
• Estimated Primary Completion Date: May 2023
• Estimated Study Completion Date: June 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 [ Time Frame: Change from baseline to day 21 ]
   7-item questionnaire assessing fatigue severity
2. Brain Fog Severity Scale [ Time Frame: Change from baseline to day 21 ]
   7-item questionnaire assessing brain fog severity

Secondary Outcome Measures :

1. Patient Global Impression of Change (PGIC) [ Time Frame: Day 21 ]
   Change in symptoms on 7-point scale
2. Well-Being Scale [ Time Frame: 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) [ Time Frame: Change from baseline to day 21 ]
   Quality of life assessment over past week
4. Desire to Continue Therapy [ Time Frame: Day 21 ]
   Single Yes/No question
5. Generalized Anxiety Disorder-2 Scale [ Time Frame: Change from baseline to day 21 ]
   2-item questionnaire assessing anxiety frequency over the past week
6. Headache and Body Pain Bother Scale [ Time Frame: Change from baseline to day 21 ]
   2-item questionnaire assessing frequency of headaches and body pain over the past week
7. Insomnia Severity Index [ Time Frame: Change from baseline to day 21 ]
   7-item questionnaire assessing insomnia severity over the past week
8. Sense of Smell and Taste Change Scale [ Time Frame: Day 21 ]
   Subjective change from baseline on a 7-point scale
9. Digit Symbol Substitution Test [ Time Frame: Change from baseline to day 21 ]
   Validated cognitive test
10. Delayed Recall Test [ Time Frame: Change from baseline to day 21 ]
    Validated cognitive test

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts

Contact: Thomas Guttuso, Jr., MD; 716-829-5454; tguttuso@buffalo.edu

Contact: Rachel Shepherd, NP

Locations

United States, New York

University at Buffalo; Recruiting

Williamsville, New York, United States, 14221

Contact: Thomas Guttuso, Jr., MD 716-829-5454 tguttuso@buffalo.edu

Sponsors and Collaborators

State University of New York at Buffalo

Investigators

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

More Information

• Responsible Party: Thomas Guttuso, Professor of Neurology, State University of New York at Buffalo
• ClinicalTrials.gov Identifier: NCT05618587
• Other Study ID Numbers: STUDY00006678
• First Posted: November 16, 2022
• Last Update Posted: February 14, 2023
• Last Verified: February 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Thomas Guttuso, State University of New York at Buffalo:

lithium, long COVID

Additional relevant MeSH terms:

Lithium Carbonate; Antidepressive Agents; Psychotropic Drugs; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Antimanic Agents; Tranquilizing Agents; Central Nervous System Depressants; Physiological Effects of Drugs