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| ID | Type | Description | Link |
|---|---|---|---|
| UL1TR001412 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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This study will assess low-dose lithium's effects on several different symptoms experienced by long COVID patients.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lithium | Experimental | Lithium 10mg po qd |
|
| Placebo | Placebo Comparator | Placebo identically matching the lithium pills |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lithium | Drug | Lithium has multiple mechanisms of action including anti-inflammatory actions, which may be relevant for treating long COVID. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fatigue Severity Scale | 7-item questionnaire assessing fatigue severity. Score range 1-49 with higher values signifying worse outcome | Change from baseline to day 21 |
| Brain Fog Severity Scale | 7-item questionnaire assessing brain fog severity. Score range 1-49 with higher values signifying worse outcome | Change from baseline to day 21 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Global Impression of Change (PGIC) | Change in symptoms on 7-point scale. Single-item scale. Score range 1-7 with higher values signifying better outcome | Day 21 |
| Well-Being Scale | Sense of well-being over past week on 10-point scale. Score range 0-10 with higher values signifying better outcome. |
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Guttuso, Jr., MD | University at Buffalo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University at Buffalo | Williamsville | New York | 14221 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39356507 | Derived | Guttuso T Jr, Zhu J, Wilding GE. Lithium Aspartate for Long COVID Fatigue and Cognitive Dysfunction: A Randomized Clinical Trial. JAMA Netw Open. 2024 Oct 1;7(10):e2436874. doi: 10.1001/jamanetworkopen.2024.36874. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lithium | Lithium 10mg po qd Lithium: Lithium has multiple mechanisms of action including anti-inflammatory actions, which may be relevant for treating long COVID. |
| FG001 | Placebo | Placebo identically matching the lithium pills Placebo: Inactive pill |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lithium | Lithium 10mg po qd Lithium: Lithium has multiple mechanisms of action including anti-inflammatory actions, which may be relevant for treating long COVID. |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Fatigue Severity Scale | 7-item questionnaire assessing fatigue severity. Score range 1-49 with higher values signifying worse outcome | Posted | Mean | Standard Deviation | score on a scale | Change from baseline to day 21 |
|
5-weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lithium | Lithium 10mg po qd Lithium: Lithium has multiple mechanisms of action including anti-inflammatory actions, which may be relevant for treating long COVID. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas Guttuso, Jr., MD | University at Buffalo | 716-932-6080 | tguttuso@buffalo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 1, 2023 | Oct 19, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000094024 | Post-Acute COVID-19 Syndrome |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
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| ID | Term |
|---|---|
| D008094 | Lithium |
| ID | Term |
|---|---|
| D008672 | Metals, Alkali |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D019565 | Metals, Light |
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| Placebo | Drug | Inactive pill |
|
| Change from baseline to day 21 |
| Short Form-12 Health Survey (1-week Modification) | 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. | Change from baseline to day 21 |
| Desire to Continue Therapy | Single Yes/No question. Single-item scale. Score range 1-2 with higher value signifying better outcome. Reported as % of respondents recording "yes". | Day 21 |
| Generalized Anxiety Disorder-2 Scale | 2-item questionnaire assessing anxiety frequency over the past week. 2-item scale. Score range 0-6 with higher values signifying worse outcome | Change from baseline to day 21 |
| Headache and Body Pain Bother Scale | 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 | Change from baseline to day 21 |
| Insomnia Severity Index | 7-item questionnaire assessing insomnia severity over the past week. 7-item scale. Score range 0-28 with higher values signifying worse outcome. | Change from baseline to day 21 |
| Sense of Smell and Taste Change Scale | 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. | Day 21 |
| Digit Symbol Substitution Test | Validated cognitive test. Score range 0-100 with higher scores indicating a better outcome. | Change from baseline to day 21 |
| Delayed Recall Test | Validated cognitive test. Score range 0-5 with higher scores indicating better outcomes. | Change from baseline to day 21 |
Placebo identically matching the lithium pills
Placebo: Inactive pill
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
|
| Primary | Brain Fog Severity Scale | 7-item questionnaire assessing brain fog severity. Score range 1-49 with higher values signifying worse outcome | Posted | Mean | Standard Deviation | score on a scale | Change from baseline to day 21 |
|
|
|
|
| Secondary | Patient Global Impression of Change (PGIC) | Change in symptoms on 7-point scale. Single-item scale. Score range 1-7 with higher values signifying better outcome | Posted | Mean | Standard Deviation | score on a scale | Day 21 |
|
|
|
|
| Secondary | Well-Being Scale | Sense of well-being over past week on 10-point scale. Score range 0-10 with higher values signifying better outcome. | Posted | Mean | Standard Deviation | score on a scale | Change from baseline to day 21 |
|
|
|
|
| Secondary | Short Form-12 Health Survey (1-week Modification) | 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. | Posted | Mean | Standard Deviation | score on a scale | Change from baseline to day 21 |
|
|
|
|
| Secondary | Desire to Continue Therapy | Single Yes/No question. Single-item scale. Score range 1-2 with higher value signifying better outcome. Reported as % of respondents recording "yes". | Posted | Count of Participants | Participants | Day 21 |
|
|
|
|
| Secondary | Generalized Anxiety Disorder-2 Scale | 2-item questionnaire assessing anxiety frequency over the past week. 2-item scale. Score range 0-6 with higher values signifying worse outcome | Posted | Mean | Standard Deviation | score on a scale | 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, Headache score. 2-item scale. Score range 2-10 with higher values signifying worse outcome | Posted | Mean | Standard Deviation | score on a scale | Change from baseline to day 21 |
|
|
|
|
| Secondary | Insomnia Severity Index | 7-item questionnaire assessing insomnia severity over the past week. 7-item scale. Score range 0-28 with higher values signifying worse outcome. | Posted | Mean | Standard Deviation | score on a scale | Change from baseline to day 21 |
|
|
|
|
| Secondary | Sense of Smell and Taste Change Scale | 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. | Posted | Mean | Standard Deviation | score on a scale | Day 21 |
|
|
|
|
| Secondary | Digit Symbol Substitution Test | Validated cognitive test. Score range 0-100 with higher scores indicating a better outcome. | Posted | Mean | Standard Deviation | score on a scale | Change from baseline to day 21 |
|
|
|
|
| Secondary | Delayed Recall Test | Validated cognitive test. Score range 0-5 with higher scores indicating better outcomes. | Posted | Mean | Standard Deviation | score on a scale | Change from baseline to day 21 |
|
|
|
|
| 0 |
| 24 |
| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | Placebo | Placebo identically matching the lithium pills Placebo: Inactive pill | 0 | 26 | 0 | 26 | 0 | 26 |
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| D007239 |
| Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008670 |
| Metals |