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Trial - NCT04570449


Column Value
Trial registration number NCT04570449
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04570449

First author
Last imported at : Dec. 26, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Erika Saunders, MD

Contact
Last imported at : Dec. 26, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

esaunders@pennstatehealth.psu.edu

Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2020-09-30

Recruitment status
Last imported at : Dec. 26, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Withdrawn

Study design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

single-center

Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

inclusion criteria: english speaking participant 18 years of age or older able to give informed consent tested positive for active sars-cov-2 infection and it's been less than 10 days since symptoms first appeared; fever persists for longer than 24 hours without the use of fever reducing medications; and experiencing other symptoms of covid-19 as described by the cdc

Exclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

prisoner or institutionalized patient unable to give informed consent less than 18 years of age hospitalization active bleeding requiring blood products in past week diagnosed with bipolar disorder and not on mood stabilizing medication known allergy or hypersensitivity to fluoxetine currently taking a monoamine oxidase inhibitor (maoi) currently taking an selective serotonin reuptake inhibitor (ssri) or selective norepinephrine reuptake inhibitor (snri) outpatient and currently taking hydroxychloroquine known pregnancy breastfeeding known prolonged qtc, such as congenital prolonged qtc syndromes

Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Milton S. Hershey Medical Center

Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

United States

Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Mild disease at enrollment

Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

1: Mild disease at enrollment

Total sample size
Last imported at : Dec. 26, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

0

primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Rate of hospitalization;Physical symptoms assessed through daily checklist

Notes
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov

Phase 1

Arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 520, "treatment_name": "Fluoxetine", "treatment_type": "Central nervous system agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]