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Completed

NCT Number: NCT05618587

Effect of Lithium Therapy on Long COVID Symptoms

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

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Key information

Conditions

Long COVID COVID-19 Chronic Disease Coronaviridae Infections Coronavirus Infections Disease Attributes Infections Lung Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral Post-Acute COVID-19 Syndrome Post-Infectious Disorders RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University at Buffalo

Williamsville, New York, 14221, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • Documented or self-reported positive test for COVID-19 ≥4 weeks prior to enrollment.
  • No fever for ≥4 weeks prior to enrollment.
  • 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.
  • Fatigue Severity Scale (FSS) score ≥28 or Brain Fog Severity Scale (BFSS) score ≥28 at baseline.
  • Beck Depression Inventory II score <24.
  • No change in any psychoactive or steroid medications for ≥30 days.
  • 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.
  • 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.
  • No history of fibromyalgia, chronic fatigue syndrome or progressive cognitive disorder prior to COVID-19 infection.
  • No active medical, psychiatric or social problems that would interfere with completing the study procedures in the opinion of the investigator.
  • No use of tobacco or marijuana products for >6 months and no current alcohol abuse (≥4 drinks/day) or illicit drug use.
  • Not receiving or applying for disability payments or workman's compensation for long COVID.
  • Not pregnant or nursing or planning to get pregnant over the next two months.

Treatment and study plan

Lithium

Drug

Lithium has multiple mechanisms of action including anti-inflammatory actions, which may be relevant for treating long COVID.

Placebo

Drug

Inactive pill

Primary outcomes

  1. Fatigue Severity Scale

    Time frame: Change from baseline to day 21

    7-item questionnaire assessing fatigue severity. Score range 1-49 with higher values signifying worse outcome

  2. Brain Fog Severity Scale

    Time frame: Change from baseline to day 21

    7-item questionnaire assessing brain fog severity. Score range 1-49 with higher values signifying worse outcome

Secondary outcomes

  1. Patient Global Impression of Change (PGIC)

    Time frame: Day 21

    Change in symptoms on 7-point scale. Single-item scale. Score range 1-7 with higher values signifying better outcome

  2. Well-Being Scale

    Time frame: Change from baseline to day 21

    Sense of well-being over past week on 10-point scale. Score range 0-10 with higher values signifying better outcome.

  3. Short Form-12 Health Survey (1-week Modification)

    Time frame: Change from baseline to day 21

    Quality of life assessment over past week, PCS-subscale. 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.

  4. Desire to Continue Therapy

    Time frame: Day 21

    Single Yes/No question. Single-item scale. Score range 1-2 with higher value signifying better outcome. Reported as % of respondents recording "yes".

  5. Generalized Anxiety Disorder-2 Scale

    Time frame: Change from baseline to day 21

    2-item questionnaire assessing anxiety frequency over the past week. 2-item scale. Score range 0-6 with higher values signifying worse outcome

  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, Headache score. 2-item scale. Score range 2-10 with higher values signifying worse outcome

  7. Insomnia Severity Index

    Time frame: Change from baseline to day 21

    7-item questionnaire assessing insomnia severity over the past week. 7-item scale. Score range 0-28 with higher values signifying worse outcome.

  8. Sense of Smell and Taste Change Scale

    Time frame: Day 21

    Subjective change from baseline on a 7-point scale (score range: 1-7) with higher scores indicating better outcomes. Scores of 1 and 7 indicate sense of smell and taste were "very much worse" or "very much improved", respectively, since the start of study treatment.

  9. Digit Symbol Substitution Test

    Time frame: Change from baseline to day 21

    Validated cognitive test. Score range 0-100 with higher scores indicating a better outcome.

  10. Delayed Recall Test

    Time frame: Change from baseline to day 21

    Validated cognitive test. Score range 0-5 with higher scores indicating better outcomes.

Sponsors and collaborators

Lead sponsor

State University of New York at Buffalo

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 16, 2022
Registry last updated
Mar 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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