Trial Outcomes & Findings for Fluvoxamine for Long COVID-19 (NCT NCT05874037)
NCT ID: NCT05874037
Last Updated: 2026-06-25
Results Overview
Participants completed a self-report twice-daily questionnaire which asks about trouble concentrating, anxiety, depression and fatigue. Respondents rate how much of a problem the symptom is "right now" on a scale of 0 (no problem) to 100 (severe problem). Results compare the change in average total scores (of the four symptoms) from baseline and endpoint.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
191 participants
Primary outcome timeframe
Assessed at Baseline (2 weeks prior to randomization) and Endpoint (last 4 weeks of randomized period)
Results posted on
2026-06-25
Participant Flow
42 individuals enrolled (signed consent) to the study but were not randomized as they either withdrew consent, became lost to follow up or no longer met inclusion criteria.
Participant milestones
| Measure |
Fluvoxamine
Participants are randomized to an individually tailored course of fluvoxamine, vs. a matched placebo, for 16 weeks.
|
Placebo
Participants are randomized to an individually tailored course of fluvoxamine, vs. a matched placebo, for 16 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
74
|
75
|
|
Overall Study
COMPLETED
|
66
|
71
|
|
Overall Study
NOT COMPLETED
|
8
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
One participant refused/preferred not to answer
Baseline characteristics by cohort
| Measure |
Fluvoxamine
n=66 Participants
Participants are randomized to an individually tailored course of fluvoxamine, vs. a matched placebo, for 16 weeks.
|
Placebo
n=71 Participants
Participants are randomized to an individually tailored course of fluvoxamine, vs. a matched placebo, for 16 weeks.
|
Total
n=137 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51 years
n=66 Participants
|
53 years
n=71 Participants
|
52 years
n=137 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=66 Participants
|
44 Participants
n=71 Participants
|
88 Participants
n=137 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=66 Participants
|
27 Participants
n=71 Participants
|
49 Participants
n=137 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=66 Participants
|
2 Participants
n=71 Participants
|
3 Participants
n=137 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
65 Participants
n=66 Participants
|
69 Participants
n=71 Participants
|
134 Participants
n=137 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=66 Participants
|
0 Participants
n=71 Participants
|
0 Participants
n=137 Participants
|
|
Race/Ethnicity, Customized
White
|
59 Participants
n=66 Participants
|
61 Participants
n=71 Participants
|
120 Participants
n=137 Participants
|
|
Race/Ethnicity, Customized
Black
|
4 Participants
n=66 Participants
|
6 Participants
n=71 Participants
|
10 Participants
n=137 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=66 Participants
|
3 Participants
n=71 Participants
|
5 Participants
n=137 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=66 Participants
|
1 Participants
n=71 Participants
|
2 Participants
n=137 Participants
|
|
Education
|
15.7 years
STANDARD_DEVIATION 0.3 • n=66 Participants • One participant refused/preferred not to answer
|
16.1 years
STANDARD_DEVIATION 0.3 • n=70 Participants • One participant refused/preferred not to answer
|
15.9 years
STANDARD_DEVIATION 0.2 • n=136 Participants • One participant refused/preferred not to answer
|
|
Coexisting conditions, No (%)
Asthma or other Chronic Lung Disease
|
13 Participants
n=66 Participants
|
17 Participants
n=71 Participants
|
30 Participants
n=137 Participants
|
|
Coexisting conditions, No (%)
Hypertension
|
14 Participants
n=66 Participants
|
16 Participants
n=71 Participants
|
30 Participants
n=137 Participants
|
|
Coexisting conditions, No (%)
Diabetes
|
5 Participants
n=66 Participants
|
6 Participants
n=71 Participants
|
11 Participants
n=137 Participants
|
|
Coexisting conditions, No (%)
Heart Disease
|
5 Participants
n=66 Participants
|
1 Participants
n=71 Participants
|
6 Participants
n=137 Participants
|
|
Coexisting conditions, No (%)
Immune Disorder
|
12 Participants
n=66 Participants
|
9 Participants
n=71 Participants
|
21 Participants
n=137 Participants
|
|
Coexisting conditions, No (%)
Depression
|
16 Participants
n=66 Participants
|
14 Participants
n=71 Participants
|
30 Participants
n=137 Participants
|
|
Coexisting conditions, No (%)
Anxiety
|
12 Participants
n=66 Participants
|
13 Participants
n=71 Participants
|
25 Participants
n=137 Participants
|
|
Time since first notice symptoms median (IQR), month
|
27.4 month
n=66 Participants
|
27.9 month
n=71 Participants
|
27.6 month
n=137 Participants
|
|
Baseline Long COVID symptoms Mean (SD)
trouble concentrating
|
70.6 scores on a scale
STANDARD_DEVIATION 14.8 • n=66 Participants
|
70.1 scores on a scale
STANDARD_DEVIATION 16.2 • n=71 Participants
|
70.3 scores on a scale
STANDARD_DEVIATION 15.5 • n=137 Participants
|
|
Baseline Long COVID symptoms Mean (SD)
feeling anxious or nervous
|
53.9 scores on a scale
STANDARD_DEVIATION 26.0 • n=66 Participants
|
51.7 scores on a scale
STANDARD_DEVIATION 27.4 • n=71 Participants
|
52.8 scores on a scale
STANDARD_DEVIATION 26.6 • n=137 Participants
|
|
Baseline Long COVID symptoms Mean (SD)
feeling sad or depressed
|
39.8 scores on a scale
STANDARD_DEVIATION 25.8 • n=66 Participants
|
29.9 scores on a scale
STANDARD_DEVIATION 26.1 • n=71 Participants
|
39.8 scores on a scale
STANDARD_DEVIATION 25.9 • n=137 Participants
|
|
Baseline Long COVID symptoms Mean (SD)
feeling fatigued
|
82.9 scores on a scale
STANDARD_DEVIATION 15.6 • n=66 Participants
|
79.4 scores on a scale
STANDARD_DEVIATION 17.9 • n=71 Participants
|
81.1 scores on a scale
STANDARD_DEVIATION 16.9 • n=137 Participants
|
|
Baseline Long COVID symptoms Mean (SD)
total (of all 4) symptoms
|
247.3 scores on a scale
STANDARD_DEVIATION 57.4 • n=66 Participants
|
241.0 scores on a scale
STANDARD_DEVIATION 57.0 • n=71 Participants
|
244.0 scores on a scale
STANDARD_DEVIATION 57.1 • n=137 Participants
|
|
Received treatment with oxygen due to COVID-19 or related problems?
Yes
|
7 Participants
n=66 Participants
|
6 Participants
n=71 Participants
|
13 Participants
n=137 Participants
|
|
Received treatment with oxygen due to COVID-19 or related problems?
No
|
59 Participants
n=66 Participants
|
65 Participants
n=71 Participants
|
124 Participants
n=137 Participants
|
|
Visited emergency room or urgent care due to COVID-19?
Yes
|
34 Participants
n=66 Participants
|
26 Participants
n=71 Participants
|
60 Participants
n=137 Participants
|
|
Visited emergency room or urgent care due to COVID-19?
No
|
32 Participants
n=66 Participants
|
45 Participants
n=71 Participants
|
77 Participants
n=137 Participants
|
|
Hospitalized due to COVID-19 or relate problems?
Yes
|
11 Participants
n=66 Participants
|
16 Participants
n=71 Participants
|
27 Participants
n=137 Participants
|
|
Hospitalized due to COVID-19 or relate problems?
No
|
55 Participants
n=66 Participants
|
55 Participants
n=71 Participants
|
110 Participants
n=137 Participants
|
|
Percentage recovered at baseline mean (SD) [range]
|
49 %
STANDARD_DEVIATION 23.0 • n=66 Participants
|
51 %
STANDARD_DEVIATION 21.7 • n=71 Participants
|
50 %
STANDARD_DEVIATION 22.2 • n=137 Participants
|
PRIMARY outcome
Timeframe: Assessed at Baseline (2 weeks prior to randomization) and Endpoint (last 4 weeks of randomized period)Participants completed a self-report twice-daily questionnaire which asks about trouble concentrating, anxiety, depression and fatigue. Respondents rate how much of a problem the symptom is "right now" on a scale of 0 (no problem) to 100 (severe problem). Results compare the change in average total scores (of the four symptoms) from baseline and endpoint.
Outcome measures
| Measure |
Fluvoxamine
n=66 Participants
Participants are randomized to an individually tailored course of fluvoxamine, vs. a matched placebo, for 16 weeks.
|
Placebo
n=71 Participants
Participants are randomized to an individually tailored course of fluvoxamine, vs. a matched placebo, for 16 weeks.
|
|---|---|---|
|
Change in Total Symptom Scores
|
-47.3 change in score
Standard Error 8.1
|
-31.1 change in score
Standard Error 7.0
|
Adverse Events
Fluvoxamine
Serious events: 5 serious events
Other events: 25 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Fluvoxamine
n=66 participants at risk
Participants are randomized to an individually tailored course of fluvoxamine, vs. a matched placebo, for 16 weeks.
|
Placebo
n=71 participants at risk
Participants are randomized to an individually tailored course of fluvoxamine, vs. a matched placebo, for 16 weeks.
|
|---|---|---|
|
General disorders
appendicitis
|
1.5%
1/66 • 16 weeks
EMA surveys administered during lead-in phase were in regard to Long COVID symptoms (disease under study) and not adverse events. The open label use option after the randomized period provided each participant the chance to try fluvoxamine for Long COVID symptoms. No data was collected during this period.
|
0.00%
0/71 • 16 weeks
EMA surveys administered during lead-in phase were in regard to Long COVID symptoms (disease under study) and not adverse events. The open label use option after the randomized period provided each participant the chance to try fluvoxamine for Long COVID symptoms. No data was collected during this period.
|
|
General disorders
cerebrovascular accident
|
0.00%
0/66 • 16 weeks
EMA surveys administered during lead-in phase were in regard to Long COVID symptoms (disease under study) and not adverse events. The open label use option after the randomized period provided each participant the chance to try fluvoxamine for Long COVID symptoms. No data was collected during this period.
|
1.4%
1/71 • 16 weeks
EMA surveys administered during lead-in phase were in regard to Long COVID symptoms (disease under study) and not adverse events. The open label use option after the randomized period provided each participant the chance to try fluvoxamine for Long COVID symptoms. No data was collected during this period.
|
|
General disorders
pulmonary embolism
|
0.00%
0/66 • 16 weeks
EMA surveys administered during lead-in phase were in regard to Long COVID symptoms (disease under study) and not adverse events. The open label use option after the randomized period provided each participant the chance to try fluvoxamine for Long COVID symptoms. No data was collected during this period.
|
1.4%
1/71 • 16 weeks
EMA surveys administered during lead-in phase were in regard to Long COVID symptoms (disease under study) and not adverse events. The open label use option after the randomized period provided each participant the chance to try fluvoxamine for Long COVID symptoms. No data was collected during this period.
|
|
Blood and lymphatic system disorders
leukocytosis
|
1.5%
1/66 • 16 weeks
EMA surveys administered during lead-in phase were in regard to Long COVID symptoms (disease under study) and not adverse events. The open label use option after the randomized period provided each participant the chance to try fluvoxamine for Long COVID symptoms. No data was collected during this period.
|
0.00%
0/71 • 16 weeks
EMA surveys administered during lead-in phase were in regard to Long COVID symptoms (disease under study) and not adverse events. The open label use option after the randomized period provided each participant the chance to try fluvoxamine for Long COVID symptoms. No data was collected during this period.
|
|
Cardiac disorders
atrial fibrillation
|
1.5%
1/66 • 16 weeks
EMA surveys administered during lead-in phase were in regard to Long COVID symptoms (disease under study) and not adverse events. The open label use option after the randomized period provided each participant the chance to try fluvoxamine for Long COVID symptoms. No data was collected during this period.
|
0.00%
0/71 • 16 weeks
EMA surveys administered during lead-in phase were in regard to Long COVID symptoms (disease under study) and not adverse events. The open label use option after the randomized period provided each participant the chance to try fluvoxamine for Long COVID symptoms. No data was collected during this period.
|
|
Gastrointestinal disorders
bowel perforation
|
1.5%
1/66 • 16 weeks
EMA surveys administered during lead-in phase were in regard to Long COVID symptoms (disease under study) and not adverse events. The open label use option after the randomized period provided each participant the chance to try fluvoxamine for Long COVID symptoms. No data was collected during this period.
|
0.00%
0/71 • 16 weeks
EMA surveys administered during lead-in phase were in regard to Long COVID symptoms (disease under study) and not adverse events. The open label use option after the randomized period provided each participant the chance to try fluvoxamine for Long COVID symptoms. No data was collected during this period.
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
1.5%
1/66 • 16 weeks
EMA surveys administered during lead-in phase were in regard to Long COVID symptoms (disease under study) and not adverse events. The open label use option after the randomized period provided each participant the chance to try fluvoxamine for Long COVID symptoms. No data was collected during this period.
|
0.00%
0/71 • 16 weeks
EMA surveys administered during lead-in phase were in regard to Long COVID symptoms (disease under study) and not adverse events. The open label use option after the randomized period provided each participant the chance to try fluvoxamine for Long COVID symptoms. No data was collected during this period.
|
Other adverse events
| Measure |
Fluvoxamine
n=66 participants at risk
Participants are randomized to an individually tailored course of fluvoxamine, vs. a matched placebo, for 16 weeks.
|
Placebo
n=71 participants at risk
Participants are randomized to an individually tailored course of fluvoxamine, vs. a matched placebo, for 16 weeks.
|
|---|---|---|
|
General disorders
agitation
|
6.1%
4/66 • Number of events 4 • 16 weeks
EMA surveys administered during lead-in phase were in regard to Long COVID symptoms (disease under study) and not adverse events. The open label use option after the randomized period provided each participant the chance to try fluvoxamine for Long COVID symptoms. No data was collected during this period.
|
1.4%
1/71 • Number of events 1 • 16 weeks
EMA surveys administered during lead-in phase were in regard to Long COVID symptoms (disease under study) and not adverse events. The open label use option after the randomized period provided each participant the chance to try fluvoxamine for Long COVID symptoms. No data was collected during this period.
|
|
Infections and infestations
COVID-19 infection (acute)
|
12.1%
8/66 • Number of events 8 • 16 weeks
EMA surveys administered during lead-in phase were in regard to Long COVID symptoms (disease under study) and not adverse events. The open label use option after the randomized period provided each participant the chance to try fluvoxamine for Long COVID symptoms. No data was collected during this period.
|
7.0%
5/71 • Number of events 5 • 16 weeks
EMA surveys administered during lead-in phase were in regard to Long COVID symptoms (disease under study) and not adverse events. The open label use option after the randomized period provided each participant the chance to try fluvoxamine for Long COVID symptoms. No data was collected during this period.
|
|
Gastrointestinal disorders
dyspepsia
|
3.0%
2/66 • Number of events 2 • 16 weeks
EMA surveys administered during lead-in phase were in regard to Long COVID symptoms (disease under study) and not adverse events. The open label use option after the randomized period provided each participant the chance to try fluvoxamine for Long COVID symptoms. No data was collected during this period.
|
5.6%
4/71 • Number of events 4 • 16 weeks
EMA surveys administered during lead-in phase were in regard to Long COVID symptoms (disease under study) and not adverse events. The open label use option after the randomized period provided each participant the chance to try fluvoxamine for Long COVID symptoms. No data was collected during this period.
|
|
General disorders
headache
|
6.1%
4/66 • Number of events 4 • 16 weeks
EMA surveys administered during lead-in phase were in regard to Long COVID symptoms (disease under study) and not adverse events. The open label use option after the randomized period provided each participant the chance to try fluvoxamine for Long COVID symptoms. No data was collected during this period.
|
2.8%
2/71 • Number of events 2 • 16 weeks
EMA surveys administered during lead-in phase were in regard to Long COVID symptoms (disease under study) and not adverse events. The open label use option after the randomized period provided each participant the chance to try fluvoxamine for Long COVID symptoms. No data was collected during this period.
|
|
General disorders
insomnia
|
10.6%
7/66 • Number of events 7 • 16 weeks
EMA surveys administered during lead-in phase were in regard to Long COVID symptoms (disease under study) and not adverse events. The open label use option after the randomized period provided each participant the chance to try fluvoxamine for Long COVID symptoms. No data was collected during this period.
|
4.2%
3/71 • Number of events 4 • 16 weeks
EMA surveys administered during lead-in phase were in regard to Long COVID symptoms (disease under study) and not adverse events. The open label use option after the randomized period provided each participant the chance to try fluvoxamine for Long COVID symptoms. No data was collected during this period.
|
|
General disorders
jittery
|
7.6%
5/66 • Number of events 5 • 16 weeks
EMA surveys administered during lead-in phase were in regard to Long COVID symptoms (disease under study) and not adverse events. The open label use option after the randomized period provided each participant the chance to try fluvoxamine for Long COVID symptoms. No data was collected during this period.
|
1.4%
1/71 • Number of events 1 • 16 weeks
EMA surveys administered during lead-in phase were in regard to Long COVID symptoms (disease under study) and not adverse events. The open label use option after the randomized period provided each participant the chance to try fluvoxamine for Long COVID symptoms. No data was collected during this period.
|
Additional Information
Eric J Lenze, MD
Washington University School of Medicine
Phone: 314-362-5154
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place