A Phase 4 interventional study of Fluoxetine in COVID-19 and Cytokine Storm, sponsored by University of Toledo Health Science Campus. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-07.
Sponsored by University of Toledo Health Science Campus · Phase 4, Interventional, and Treatment
This project will test the efficacy of fluoxetine to prevent serious consequences of COVID-19 infection, especially death. Becoming sick with COVID-19 virus or any other serious respiratory condition is not fun. However, the dramatic effects of the COVID-19 pandemic on human society stem from its significant mortality, not the number of individuals who become sick. This project aims to prevent serious outcomes such as hospitalization, respiratory failure and death during the time it takes to develop vaccinations and other strategies to prevent COVID-19 infectionPoor outcomes with COVID-19 infection such as hospitalization, respiratory failure, organ failure and death are associated with a dysfunctional exaggerated immune response, called a cytokine storm, that is triggered by Interleukin-6 expression (IL-6) and seems to occur around day 5 to 7 of symptoms. Fluoxetine has extraordinarily strong evidence in its action as a blocker of IL-6 and cytokine storms in both animal models of infection and in human illness such as rheumatoid arthritis and others. This action of fluoxetine is an entirely separate pathway than the serotonergic pathway that allows fluoxetine to act as an antidepressant. This pathway has been demonstrated in cell culture, in animal models, in human illness and by novel bioinformatics analyses of protein transcripts to be relatively unique for fluoxetine and appears to be a novel pathway. This project aims to inhibit the increase in IL-6 expression and thereby prevent the cytokine storm that causes poor outcomes. Patients who have tested positive or are presumptively positive for COVID-19 will be entered into the study and given the option to start the medication fluoxetine, which is demonstrated to prevent IL-6 surges in infectious and inflammatory conditions. Participants will be monitored daily for COVID-19 symptoms and weekly for side effects and tolerance of fluoxetine. A subset of patients will have blood drawn weekly and stored to monitor IL-6 and other cytokine levels at a later date.
This project aims to reduce the serious outcomes of COVID-19 infection by preventing or inhibiting the cytokine storm associated with organ failure, respiratory failure and death.
7,638 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 16 is below the median of 100 across 4,098 interventional studies indexed under COVID-19.
Browse COVID-19 studies →University of Toledo Health Science Campus is the lead sponsor of 35 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Overall Study Exclusion Criteria :
Exclusion from Fluoxetine Arm:
Exclusion from Blood Sample Provision:
Participants may choose to not take fluoxetine and remain in the study
Participants will take fluoxetine 20 mg initially, increasing as tolerated to a maximum of 60 mg until symptoms abate, then will be tapered by 20 mg per week off the fluoxetine Participants will be on fluoxetine for 2 weeks to 2 months depending on symptom duration
Drug: Fluoxetine
Fluoxetine 20 mg to 60 mg daily given from 2 weeks to 2 months duration
Also known as: prozac
Number of Outpatient Subject Hospitalizations
whether the subject is hospitalized for COVID-19 symptoms
Time frame: 2 months
Number of Subjects Undergoing Intubation
whether the subject is intubated for COVID-19 symptoms
Time frame: 2 months
Number of Patients Who Died Within 2 Months of Entry Into the Study
Patients who died from any cause within 2 months of entry into the study.
Time frame: 2 months
Participants With 1 or More Symptom Free Day With no COVID Primary Symptoms During 2 Months After Study Entry
Participant who achieved remission from covid with no active covid symptoms (cough, fever, shortness of breath, fatigue, muscle aches, and loss of taste and smell) from study entry
Time frame: 2 months
Participants With Patient Health Questionnaire (PHQ) -9 Score Below 10 After Baseline Assessment
depression score rating from 0 to 27 where higher scores indicate worse depression Scores of 10 or more meet criteria for diagnosis as a mild depressive episode
Time frame: 2 months
Participants With Generalized Anxiety Disorder (GAD) -7 Scale Score Below 10 After Baseline Assessment
anxiety scale with scores ranging from 0 to 21 where higher scores indicate more severe anxiety Scores of 10 or more generally indicate anxiety that might meet criteria for diagnosis as an anxiety disorder
Time frame: 2 months
| Milestone | Treatment As Usual | Fluoxetine |
|---|---|---|
| Started | 4 | 12 |
| Completed | 4 | 11 |
| Not completed | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 |
whether the subject is hospitalized for COVID-19 symptoms
| Participants | Treatment As Usual | Fluoxetine |
|---|---|---|
| Number of Outpatient Subject Hospitalizations | 0 | 0 |
whether the subject is intubated for COVID-19 symptoms
| Participants | Treatment As Usual | Fluoxetine |
|---|---|---|
| Number of Subjects Undergoing Intubation | 1 | 0 |
Patients who died from any cause within 2 months of entry into the study.
| Participants | Treatment As Usual | Fluoxetine |
|---|---|---|
| Number of Patients Who Died Within 2 Months of Entry Into the Study | 1 | 0 |
Participant who achieved remission from covid with no active covid symptoms (cough, fever, shortness of breath, fatigue, muscle aches, and loss of taste and smell) from study entry
| Participants | Treatment As Usual | Fluoxetine |
|---|---|---|
| 1 or more symptom free days | 3 | 7 |
| no symptom free days | 1 | 4 |
depression score rating from 0 to 27 where higher scores indicate worse depression Scores of 10 or more meet criteria for diagnosis as a mild depressive episode
| Participants | Treatment As Usual | Fluoxetine |
|---|---|---|
| Participants With Patient Health Questionnaire (PHQ) -9 Score Below 10 After Baseline Assessment | 4 | 10 |
anxiety scale with scores ranging from 0 to 21 where higher scores indicate more severe anxiety Scores of 10 or more generally indicate anxiety that might meet criteria for diagnosis as an anxiety disorder
| Participants | Treatment As Usual | Fluoxetine |
|---|---|---|
| Participants With Generalized Anxiety Disorder (GAD) -7 Scale Score Below 10 After Baseline Assessment | 4 | 10 |
Collected over Adverse event data was collected over up to 2 months from when each participant was enrolled by the study team.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment As Usual | 1/4 (25%) | 1/4 (25%) | 0/4 (0%) |
| Fluoxetine | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) |
| Event | Treatment As Usual | Fluoxetine |
|---|---|---|
| DeathRespiratory, thoracic and mediastinal disorders | 1/4 | — |
| Age, Continuous(Years) | Treatment As Usual | Fluoxetine | Total |
|---|---|---|---|
| Mean | 52 (44 to 61) | 46.09 (24 to 75) | 47.67 (24 to 75) |
| Sex: Female, Male(Participants) | Treatment As Usual | Fluoxetine | Total |
|---|---|---|---|
| Female | 3 | 7 | 10 |
| Male | 1 | 4 | 5 |
| Race (NIH/OMB)(Participants) | Treatment As Usual | Fluoxetine | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 1 |
| White | 4 | 10 | 14 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Treatment As Usual | Fluoxetine | Total |
|---|---|---|---|
| United States | 4 | 11 | 15 |
| Smoke Cigarettes(Participants) | Treatment As Usual | Fluoxetine | Total |
|---|---|---|---|
| Smokes cigarettes | 1 | 1 | 2 |
| Does not smoke cigarettes | 3 | 10 | 13 |
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University of Toledo Health Science Campus