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Trial - NCT04789499


Column Value
Trial registration number NCT04789499
Full text link
Last imported at : March 11, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04789499

First author
Last imported at : Feb. 4, 2022, 1:30 p.m.
Source : ClinicalTrials.gov

Jay F Piccirillo

Contact
Last imported at : Feb. 4, 2022, 1:30 p.m.
Source : ClinicalTrials.gov

piccirij@wustl.edu

Registration date
Last imported at : March 11, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

2021-03-09

Recruitment status
Last imported at : Feb. 4, 2022, 1:30 p.m.
Source : ClinicalTrials.gov

Completed

Study design
Last imported at : March 11, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : March 11, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : March 11, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : March 11, 2021, 12:31 a.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 : March 11, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Long covid

Inclusion criteria
Last imported at : March 11, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

inclusion criteria: - olfactory dysfunction that has persisted for >3 months following suspected covid-19 infection - residing within the states of missouri or illinois. - can read, write, and understand english.

Exclusion criteria
Last imported at : March 11, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

- history of olfactory dysfunction prior to covid-19 infection - use of concomitant therapies specifically for the treatment of olfactory dysfunction - history of olfactory dysfunction longer than 12 months - known existence of nasal polyps, prior sinonasal, or anterior skull-based surgery - dependence on theophylline for comorbid conditions such as asthma and copd - history of an allergic reaction to theophylline or other methylxanthines - history of neurodegenerative disease (ie. alzheimer's dementia, parkinson's disease, lewy body dementia, frontotemporal dementia) - pregnant or breastfeeding mothers - current use of medications with significant interactions with theophylline, which include cimetidine, ciprofloxacin, disulfiram, enoxacin, fluvoxamine, interferon-alpha, lithium, mexiletine, phenytoin, propafenone, propranolol, tacrine, thiabendazole, ticlopidine, and troleandomycin. - pre-existing arrhythmias or seizures

Number of arms
Last imported at : March 11, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : March 11, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Washington University School of Medicine

Inclusion age min
Last imported at : March 11, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : March 11, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

70

Countries
Last imported at : March 11, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

United States

Type of patients
Last imported at : March 11, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Patients recovered from covid

Severity scale
Last imported at : March 11, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

N/A

Total sample size
Last imported at : May 30, 2023, 3:29 p.m.
Source : ClinicalTrials.gov

51

primary outcome
Last imported at : May 30, 2023, 3:29 p.m.
Source : ClinicalTrials.gov

UPSIT

Notes
Last imported at : March 11, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : March 11, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Phase 2

Arms
Last imported at : May 30, 2023, 3:29 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 1284, "treatment_name": "Theophylline", "treatment_type": "Respiratory agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]