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Please consider this website is continuously evolving and still under development
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| Column | Value |
|---|---|
| Trial registration number | NCT05216614 |
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Full text link
Last imported at : Feb. 2, 2022, 1 p.m. Source : ClinicalTrials.gov |
|
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First author
Last imported at : March 13, 2022, midnight Source : ClinicalTrials.gov |
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Contact
Last imported at : March 13, 2022, midnight Source : ClinicalTrials.gov |
piccirij@wustl.edu |
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Registration date
Last imported at : Feb. 2, 2022, 1 p.m. Source : ClinicalTrials.gov |
2022-01-31 |
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Recruitment status
Last imported at : March 13, 2022, midnight Source : ClinicalTrials.gov |
Withdrawn |
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Study design
Last imported at : Feb. 2, 2022, 1 p.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : Feb. 2, 2022, 1 p.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : Feb. 2, 2022, 1 p.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : Feb. 2, 2022, 1 p.m. Source : ClinicalTrials.gov |
Blind label |
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Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
single-center |
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Study aim
Last imported at : Feb. 2, 2022, 1 p.m. Source : ClinicalTrials.gov |
Long covid |
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Inclusion criteria
Last imported at : Feb. 2, 2022, 1 p.m. Source : ClinicalTrials.gov |
inclusion criteria: men and women between the ages 18 to 70 years residing within the states of missouri or illinois complaints of odors of certain things or everything are distorted olfactory dysfunction that has persisted for >2 months after suspected covid-19 infection ability to read, write, and understand english |
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Exclusion criteria
Last imported at : Feb. 2, 2022, 1 p.m. Source : ClinicalTrials.gov |
history of olfactory dysfunction prior to covid-19 infection any use of concomitant therapies specifically for the treatment of olfactory dysfunction history of olfactory dysfunction of longer than 12 months history of bipolar disorder as ssris can theoretically destabilize bipolar disorder participants with symptoms of depression as evidenced by a score of 10 or greater on the patient health questionnaire-9 (phq-9).95 the phq-9 is a nine-item questionnaire designed to assess and aid in diagnosing patients with depression in clinical and community settings. history of neurodegenerative disease (i.e., alzheimer's dementia, parkinson's disease, lewy body dementia, frontotemporal dementia) history of chronic rhinosinusitis or sinus surgery pregnant or breastfeeding mothers. already enrolled in another covid 19 medication trial or receipt of monoclonal antibody infusion. taking donepezil or fluoxetine (rationale: these drugs are s1r agonists) or sertraline (a s1r antagonist). participants taking theophylline, tizanidine, clozapine, or olanzapine (drugs with a narrow therapeutic index that are primarily metabolized by cyp 1a2, which is inhibited by fluvoxamine. taking another ssri, unless at a low dose (e.g., escitalopram 5mg) such that adding fluvoxamine would not put patient at risk for serotonin syndrome. taking coumadin based on theoretical risk of increased bleeding with fluvoxamine. unable to provide informed consent. unable to perform the study procedures. |
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Number of arms
Last imported at : Feb. 2, 2022, 1 p.m. Source : ClinicalTrials.gov |
2 |
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Funding
Last imported at : Feb. 2, 2022, 1 p.m. Source : ClinicalTrials.gov |
Washington University School of Medicine |
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Inclusion age min
Last imported at : Feb. 2, 2022, 1 p.m. Source : ClinicalTrials.gov |
18 |
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Inclusion age max
Last imported at : Feb. 2, 2022, 1 p.m. Source : ClinicalTrials.gov |
70 |
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Countries
Last imported at : Feb. 2, 2022, 1 p.m. Source : ClinicalTrials.gov |
United States |
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Type of patients
Last imported at : Feb. 2, 2022, 1 p.m. Source : ClinicalTrials.gov |
Patients recovered from covid |
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Severity scale
Last imported at : Feb. 2, 2022, 1 p.m. Source : ClinicalTrials.gov |
N/A |
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Total sample size
Last imported at : March 13, 2022, midnight Source : ClinicalTrials.gov |
0 |
|
primary outcome
Last imported at : Feb. 2, 2022, 1 p.m. Source : ClinicalTrials.gov |
Clinical Global Impression Scale (CGI) |
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Notes
Last imported at : Feb. 2, 2022, 1 p.m. Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : Feb. 2, 2022, 1 p.m. Source : ClinicalTrials.gov |
Phase 2 |
|
Arms
Last imported at : Feb. 2, 2022, 1 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 522, "treatment_name": "Fluvoxamine", "treatment_type": "Central nervous system agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |