Trial Outcomes & Findings for Effect of Lithium Therapy on Long COVID Symptoms (NCT NCT05618587)
NCT ID: NCT05618587
Last Updated: 2025-03-05
Results Overview
7-item questionnaire assessing fatigue severity. Score range 1-49 with higher values signifying worse outcome
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
52 participants
Primary outcome timeframe
Change from baseline to day 21
Results posted on
2025-03-05
Participant Flow
Participant milestones
| Measure |
Lithium
Lithium 10mg po qd
Lithium: Lithium has multiple mechanisms of action including anti-inflammatory actions, which may be relevant for treating long COVID.
|
Placebo
Placebo identically matching the lithium pills
Placebo: Inactive pill
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
26
|
|
Overall Study
COMPLETED
|
24
|
26
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Lithium
Lithium 10mg po qd
Lithium: Lithium has multiple mechanisms of action including anti-inflammatory actions, which may be relevant for treating long COVID.
|
Placebo
Placebo identically matching the lithium pills
Placebo: Inactive pill
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
Baseline Characteristics
Effect of Lithium Therapy on Long COVID Symptoms
Baseline characteristics by cohort
| Measure |
Lithium
n=24 Participants
Lithium 10mg po qd
Lithium: Lithium has multiple mechanisms of action including anti-inflammatory actions, which may be relevant for treating long COVID.
|
Placebo
n=26 Participants
Placebo identically matching the lithium pills
Placebo: Inactive pill
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Age, Continuous
|
62.3 years
STANDARD_DEVIATION 14.3 • n=5 Participants
|
55.0 years
STANDARD_DEVIATION 13.7 • n=7 Participants
|
58.5 years
STANDARD_DEVIATION 14.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
24 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Change from baseline to day 217-item questionnaire assessing fatigue severity. Score range 1-49 with higher values signifying worse outcome
Outcome measures
| Measure |
Lithium
n=24 Participants
Lithium 10mg po qd
Lithium: Lithium has multiple mechanisms of action including anti-inflammatory actions, which may be relevant for treating long COVID.
|
Placebo
n=26 Participants
Placebo identically matching the lithium pills
Placebo: Inactive pill
|
|---|---|---|
|
Fatigue Severity Scale
|
-11.3 score on a scale
Standard Deviation 12.6
|
-8.6 score on a scale
Standard Deviation 12.3
|
PRIMARY outcome
Timeframe: Change from baseline to day 217-item questionnaire assessing brain fog severity. Score range 1-49 with higher values signifying worse outcome
Outcome measures
| Measure |
Lithium
n=24 Participants
Lithium 10mg po qd
Lithium: Lithium has multiple mechanisms of action including anti-inflammatory actions, which may be relevant for treating long COVID.
|
Placebo
n=26 Participants
Placebo identically matching the lithium pills
Placebo: Inactive pill
|
|---|---|---|
|
Brain Fog Severity Scale
|
-9.0 score on a scale
Standard Deviation 13.8
|
-8.1 score on a scale
Standard Deviation 10.6
|
SECONDARY outcome
Timeframe: Day 21Change in symptoms on 7-point scale. Single-item scale. Score range 1-7 with higher values signifying better outcome
Outcome measures
| Measure |
Lithium
n=24 Participants
Lithium 10mg po qd
Lithium: Lithium has multiple mechanisms of action including anti-inflammatory actions, which may be relevant for treating long COVID.
|
Placebo
n=26 Participants
Placebo identically matching the lithium pills
Placebo: Inactive pill
|
|---|---|---|
|
Patient Global Impression of Change (PGIC)
|
4.7 score on a scale
Standard Deviation 1.1
|
4.6 score on a scale
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: Change from baseline to day 21Sense of well-being over past week on 10-point scale. Score range 0-10 with higher values signifying better outcome.
Outcome measures
| Measure |
Lithium
n=24 Participants
Lithium 10mg po qd
Lithium: Lithium has multiple mechanisms of action including anti-inflammatory actions, which may be relevant for treating long COVID.
|
Placebo
n=26 Participants
Placebo identically matching the lithium pills
Placebo: Inactive pill
|
|---|---|---|
|
Well-Being Scale
|
1.0 score on a scale
Standard Deviation 2.0
|
0.9 score on a scale
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: Change from baseline to day 21Quality 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.
Outcome measures
| Measure |
Lithium
n=24 Participants
Lithium 10mg po qd
Lithium: Lithium has multiple mechanisms of action including anti-inflammatory actions, which may be relevant for treating long COVID.
|
Placebo
n=26 Participants
Placebo identically matching the lithium pills
Placebo: Inactive pill
|
|---|---|---|
|
Short Form-12 Health Survey (1-week Modification)
|
5.1 score on a scale
Standard Deviation 8.5
|
4.2 score on a scale
Standard Deviation 11.1
|
SECONDARY outcome
Timeframe: Day 21Single Yes/No question. Single-item scale. Score range 1-2 with higher value signifying better outcome. Reported as % of respondents recording "yes".
Outcome measures
| Measure |
Lithium
n=24 Participants
Lithium 10mg po qd
Lithium: Lithium has multiple mechanisms of action including anti-inflammatory actions, which may be relevant for treating long COVID.
|
Placebo
n=26 Participants
Placebo identically matching the lithium pills
Placebo: Inactive pill
|
|---|---|---|
|
Desire to Continue Therapy
|
12 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Change from baseline to day 212-item questionnaire assessing anxiety frequency over the past week. 2-item scale. Score range 0-6 with higher values signifying worse outcome
Outcome measures
| Measure |
Lithium
n=24 Participants
Lithium 10mg po qd
Lithium: Lithium has multiple mechanisms of action including anti-inflammatory actions, which may be relevant for treating long COVID.
|
Placebo
n=26 Participants
Placebo identically matching the lithium pills
Placebo: Inactive pill
|
|---|---|---|
|
Generalized Anxiety Disorder-2 Scale
|
-0.8 score on a scale
Standard Deviation 1.7
|
-1.4 score on a scale
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: Change from baseline to day 212-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
Outcome measures
| Measure |
Lithium
n=24 Participants
Lithium 10mg po qd
Lithium: Lithium has multiple mechanisms of action including anti-inflammatory actions, which may be relevant for treating long COVID.
|
Placebo
n=26 Participants
Placebo identically matching the lithium pills
Placebo: Inactive pill
|
|---|---|---|
|
Headache and Body Pain Bother Scale
|
-0.6 score on a scale
Standard Deviation 0.7
|
-0.7 score on a scale
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: Change from baseline to day 217-item questionnaire assessing insomnia severity over the past week. 7-item scale. Score range 0-28 with higher values signifying worse outcome.
Outcome measures
| Measure |
Lithium
n=24 Participants
Lithium 10mg po qd
Lithium: Lithium has multiple mechanisms of action including anti-inflammatory actions, which may be relevant for treating long COVID.
|
Placebo
n=26 Participants
Placebo identically matching the lithium pills
Placebo: Inactive pill
|
|---|---|---|
|
Insomnia Severity Index
|
-6.0 score on a scale
Standard Deviation 6.7
|
-4.4 score on a scale
Standard Deviation 4.8
|
SECONDARY outcome
Timeframe: Day 21Subjective 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.
Outcome measures
| Measure |
Lithium
n=24 Participants
Lithium 10mg po qd
Lithium: Lithium has multiple mechanisms of action including anti-inflammatory actions, which may be relevant for treating long COVID.
|
Placebo
n=26 Participants
Placebo identically matching the lithium pills
Placebo: Inactive pill
|
|---|---|---|
|
Sense of Smell and Taste Change Scale
|
4.1 score on a scale
Standard Deviation 0.3
|
4.2 score on a scale
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: Change from baseline to day 21Validated cognitive test. Score range 0-100 with higher scores indicating a better outcome.
Outcome measures
| Measure |
Lithium
n=24 Participants
Lithium 10mg po qd
Lithium: Lithium has multiple mechanisms of action including anti-inflammatory actions, which may be relevant for treating long COVID.
|
Placebo
n=26 Participants
Placebo identically matching the lithium pills
Placebo: Inactive pill
|
|---|---|---|
|
Digit Symbol Substitution Test
|
4.3 score on a scale
Standard Deviation 5.9
|
6.6 score on a scale
Standard Deviation 9.0
|
SECONDARY outcome
Timeframe: Change from baseline to day 21Validated cognitive test. Score range 0-5 with higher scores indicating better outcomes.
Outcome measures
| Measure |
Lithium
n=24 Participants
Lithium 10mg po qd
Lithium: Lithium has multiple mechanisms of action including anti-inflammatory actions, which may be relevant for treating long COVID.
|
Placebo
n=26 Participants
Placebo identically matching the lithium pills
Placebo: Inactive pill
|
|---|---|---|
|
Delayed Recall Test
|
0.46 score on a scale
Standard Deviation 1.02
|
0.35 score on a scale
Standard Deviation 0.80
|
Adverse Events
Lithium
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place