Effect of Lithium Therapy on Long COVID Symptoms

Phase 2

Completed

• Conditions: Long COVID
• Interventions: Drug: Lithium; Drug: Placebo

• Registration Number: NCT05618587
• Lead Sponsor: State University of New York at Buffalo

Brief Summary

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

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 Timeline

• Study First Submitted: 2022-11-14
• Study First Submitted QC: 2022-11-14
• Study First Posted: 2022-11-16
• Study Start: 2022-11-28
• Primary Completion: 2023-07-21
• Study Completion: 2023-07-21
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-24
• Last Update Posted: 2023-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lithium	Lithium	Lithium 10mg po qd
Placebo	Placebo	Placebo identically matching the lithium pills

Primary Outcome Measures

Name	Time	Method
Fatigue Severity Scale	Change from baseline to day 21	7-item questionnaire assessing fatigue severity
Brain Fog Severity Scale	Change from baseline to day 21	7-item questionnaire assessing brain fog severity

Secondary Outcome Measures

Name	Time	Method
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
Insomnia Severity Index	Change from baseline to day 21	7-item questionnaire assessing insomnia severity over the past week
Sense of Smell and Taste Change Scale	Day 21	Subjective change from baseline on a 7-point scale
Digit Symbol Substitution Test	Change from baseline to day 21	Validated cognitive test
Delayed Recall Test	Change from baseline to day 21	Validated cognitive test
Patient Global Impression of Change (PGIC)	Day 21	Change in symptoms on 7-point scale
Well-Being Scale	Change from baseline to day 21	Sense of well-being over past week on 10-point scale
Short Form-12 Health Survey (1-week modification)	Change from baseline to day 21	Quality of life assessment over past week
Desire to Continue Therapy	Day 21	Single Yes/No question
Generalized Anxiety Disorder-2 Scale	Change from baseline to day 21	2-item questionnaire assessing anxiety frequency over the past week

Trial Locations

Locations (1)

University at Buffalo; 🇺🇸 Williamsville, New York, United States