There are 2 clinical trials
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.
Description: whether the subject is hospitalized for COVID-19 symptomsMeasure: Hospitalizations Time: 2 months
Description: whether the subject is intubated for COVID-19 symptomsMeasure: Intubation Time: 2 months
Description: whether the subject dies of COVID-19 symptomsMeasure: Death Time: 2 months
Description: depressionMeasure: PHQ-9 score for depressive symptoms, Time: 2 months
Description: anxietyMeasure: generalized anxiety Disorder-7 scale Time: 2 months
The current research is a pilot study to determine the feasibility of recruiting and retaining 40 participants diagnosed with COVID-19. The purpose is to observe the early use of fluoxetine (commonly known as Prozac) to reduce the severity of the COVID-19 illness. Fluoxetine is a drug that has been approved by the U.S. Food and Drug Administration (FDA) since 1987 for various mental health disorders.
Description: Measures number of subjects hospitalized for COVID-19 symptomsMeasure: Rate of hospitalization Time: 8 weeks
Description: The 23-item daily symptom checklist measures the presence or absence of COVID-related symptoms (e.g. shortness of breath, fever, chills) and other possible symptoms (e.g. ear pain, vomit, seizures).Measure: Physical symptoms assessed through daily checklist Time: 8 weeks
Description: Measures number of subjects intubated for COVID-19 symptomsMeasure: Rate of intubation Time: 8 weeks
Description: Measures number of subjects who die from COVID-19 symptomsMeasure: Rate of death Time: 8 weeks
Description: Measured using the 9-item Patient Health Questionnaire (PHQ-9) each item rated on a scale of 0-3, where 0=no depressive symptoms and 3=depressive symptoms present nearly every day. A high score indicates severe depression.Measure: Depressive symptoms assessed weekly Time: 8 weeks
Description: Measured using the 4-item SPAN assessment rated on a scale from 0-4 where 0=not at all distressing and 4=extremely distressing. A score greater than 5 indicates the presence of PTSD.Measure: Post traumatic stress disorder symptoms assessed weekly Time: 8 weeks
Description: Measured using the 7-item General Anxiety Disorder Scale (GAD-7) rated from 0-3, where 0=no anxiety symptoms and 3=anxiety symptoms present nearly ever day. A high score indicates severe anxiety.Measure: Anxiety symptoms assessed weekly Time: 8 weeks
Description: Measured using the 6-item Columbia-Suicide Severity Rating Scale (C-SSRS), a semi-structured interview on the presence or absence of suicidal ideation.Measure: Suicidality assessed daily Time: 8 weeks
Data processed on January 01, 2021.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.Drug Reports MeSH Reports HPO Reports