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Fluoxetine to Reduce Intubation and Death After COVID19 Infection

Μόνο εγγεγραμμένοι χρήστες μπορούν να μεταφράσουν άρθρα
Σύνδεση εγγραφή
Ο σύνδεσμος αποθηκεύεται στο πρόχειρο
ΚατάστασηΠρόσληψη
Χορηγοί
University of Toledo Health Science Campus

Λέξεις-κλειδιά

Αφηρημένη

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.

Ημερομηνίες

Τελευταία επαλήθευση: 04/30/2020
Πρώτα υποβλήθηκε: 04/17/2020
Υποβλήθηκε εκτιμώμενη εγγραφή: 05/03/2020
Δημοσιεύτηκε για πρώτη φορά: 05/05/2020
Υποβλήθηκε τελευταία ενημέρωση: 05/03/2020
Δημοσιεύτηκε η τελευταία ενημέρωση: 05/05/2020
Ημερομηνία έναρξης της πραγματικής μελέτης: 04/30/2020
Εκτιμώμενη κύρια ημερομηνία ολοκλήρωσης: 04/19/2021
Εκτιμώμενη ημερομηνία ολοκλήρωσης μελέτης: 10/19/2021

Κατάσταση ή ασθένεια

COVID-19
Cytokine Storm

Παρέμβαση / θεραπεία

Drug: Fluoxetine

Φάση

Φάση 4

Ομάδες βραχιόνων

ΜπράτσοΠαρέμβαση / θεραπεία
No Intervention: Treatment As Usual
Participants may choose to not take fluoxetine and remain in the study
Active Comparator: Fluoxetine
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

Κριτήρια καταλληλότητας

Επιλέξιμες ηλικίες για μελέτη 18 Years Προς την 18 Years
Φύλα επιλέξιμα για μελέτηAll
Δέχεται υγιείς εθελοντέςΝαί
Κριτήρια

Inclusion Criteria:

- Patients aged 18 and above, able to give informed consent or with legally authorized representative

- COVID-19 test positive or presumptive positive awaiting COVID testing or results by following criteria: fever, cough and shortness of breath or presumptive positive by one of these 3 criteria (fever, cough or shortness of breath) and known exposure to COVID-19 positive individual in past 2 weeks

Overall Study Exclusion Criteria :

- Unable to give informed consent and no legal representativ

- Prisoner/ institutionalized patient

- Under age 18

Exclusion from Fluoxetine Arm:

- Active bleeding requiring blood products

- Bipolar disorder not on mood stabilizing medication*

- Known allergy or hypersensitivity to fluoxetine

- Currently taking the following medications : MAO I, pimozide, thioridine

- Currently taking hydroxychloroquine

- Pregnant or breastfeeding

- For hospitalized patients : QTc greater than 500 ms

- *Hospitalized patient may be on hydroxychloroquine if QTc<500 and the primary attending approves

Exclusion from Blood Sample Provision:

- Pregnant

- Self-report of under 110 pounds

Αποτέλεσμα

Πρωτεύοντα αποτελέσματα

1. Hospitalizations [2 months]

whether the subject is hospitalized for COVID-19 symptoms

2. Intubation [2 months]

whether the subject is intubated for COVID-19 symptoms

3. Death [2 months]

whether the subject dies of COVID-19 symptoms

Δευτερεύοντα αποτελέσματα

1. Number of days of illness [2 months]

2. PHQ-9 score for depressive symptoms, [2 months]

depression

3. generalized anxiety Disorder-7 scale [2 months]

anxiety

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