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NCT04377308 · ClinicalTrials.gov registry record · Phase 4
Fluoxetine to Reduce Intubation and Death After COVID19 Infection
A Phase 4 study, sponsored by University of Toledo Health Science Campus.
- Completed
- Registry status
- Phase 4
- Development phase
- 16
- Enrollment target
NCT04377308: Completed Phase 4 study, sponsored by University of Toledo Health Science Campus.
NCT04377308 is a Phase 4 study that has completed, run by University of Toledo Health Science Campus. The registered enrollment target is 16 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04377308, a Phase 4 study, has completed, sponsored by University of Toledo Health Science Campus.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 16 participants
- Enrollment target
Study Summary
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-
Primary Outcome
whether the subject is hospitalized for COVID-19 symptoms
Interventions
- DRUG Fluoxetine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2020-05-01 |
| Est. Completion | 2021-04-30 |
| Phase | Phase 4 |
What the finished NCT04377308 record still lists
NCT04377308 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which Fluoxetine is the first listed.
NCT04377308 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04377308 about?
NCT04377308 is a clinical study titled "Fluoxetine to Reduce Intubation and Death After COVID19 Infection". 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 si...
What is the current status of trial NCT04377308?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 16 participants. The study started on 2020-05-01. Estimated completion is 2021-04-30.
What interventions are being tested in trial NCT04377308?
The interventions under investigation include: Fluoxetine (DRUG).
Who is sponsoring clinical trial NCT04377308?
This trial is sponsored by University of Toledo Health Science Campus, which has 26 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04377308's enrollment target sits among peer trials
16 1869th of 2000 higher than 121 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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