Fluoxetine to Reduce Intubation and Death After COVID19 Infection
Status:
Recruiting
Trial end date:
2021-10-20
Target enrollment:
Participant gender:
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-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.