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Trial - NCT05184192


Column Value
Trial registration number NCT05184192
Full text link
Last imported at : Jan. 12, 2022, 9 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT05184192

First author
Last imported at : June 21, 2022, 7:30 p.m.
Source : ClinicalTrials.gov

Jay F Piccirillo

Contact
Last imported at : June 21, 2022, 7:30 p.m.
Source : ClinicalTrials.gov

Not reported

Registration date
Last imported at : Jan. 12, 2022, 9 a.m.
Source : ClinicalTrials.gov

2022-01-11

Recruitment status
Last imported at : April 6, 2024, 4 p.m.
Source : ClinicalTrials.gov

Completed

Study design
Last imported at : Jan. 12, 2022, 9 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Jan. 12, 2022, 9 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Jan. 12, 2022, 9 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Jan. 12, 2022, 9 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 : Jan. 12, 2022, 9 a.m.
Source : ClinicalTrials.gov

Long covid

Inclusion criteria
Last imported at : Jan. 12, 2022, 9 a.m.
Source : ClinicalTrials.gov

inclusion criteria: men and women between the ages of 18 and 65 years residing within the states of missouri or illinois clinically diagnosed or subjective olfactory dysfunction (anosmia, hyposmia, or parosmia) of 3 months duration or longer diagnosed within 2 weeks of covid-19 infection upsit score consistent with diminished olfactory function (score ≤ 33 in men and ≤ 34 in women). willing to respond daily to study surveys, preferably through smartphone with unlimited texting plan in possession of all 7 household items: soap, burnt candle, peanut butter, herb, garlic, lemon, and coffee

Exclusion criteria
Last imported at : Jan. 12, 2022, 9 a.m.
Source : ClinicalTrials.gov

clinically diagnosed olfactory dysfunction secondary to genetic abnormalities or congenital dysfunction, trauma, non-covid-19 viral infection, nasal polyps, neurodegenerative disorders current use of: azelastine, bromperidol, orophenadrine, oxomemazine, kratom, paraldehyde, or thalidomide history of addiction to alcohol, cocaine, or opioids impaired renal function, myasthenia gravis, or myoclonus severe allergy to peanuts pregnancy or attempting pregnancy during study participation inability to participate in virtual trial due to lack of access to the internet or unlimited text messaging; inability to comprehend or use english language availability less than 6 months from time of enrollment residency in states other than missouri or illinois.

Number of arms
Last imported at : Jan. 12, 2022, 9 a.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Jan. 12, 2022, 9 a.m.
Source : ClinicalTrials.gov

Washington University School of Medicine

Inclusion age min
Last imported at : Jan. 12, 2022, 9 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Jan. 12, 2022, 9 a.m.
Source : ClinicalTrials.gov

65

Countries
Last imported at : Jan. 12, 2022, 9 a.m.
Source : ClinicalTrials.gov

United States

Type of patients
Last imported at : Jan. 12, 2022, 9 a.m.
Source : ClinicalTrials.gov

Patients recovered from covid

Severity scale
Last imported at : Jan. 12, 2022, 9 a.m.
Source : ClinicalTrials.gov

N/A

Total sample size
Last imported at : April 6, 2024, 4 p.m.
Source : ClinicalTrials.gov

76

primary outcome
Last imported at : Jan. 12, 2022, 9 a.m.
Source : ClinicalTrials.gov

Clinical Global Impression of Improvement Scale (CGI-I)

Notes
Last imported at : Jan. 12, 2022, 9 a.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Jan. 12, 2022, 9 a.m.
Source : ClinicalTrials.gov

Phase 2

Arms
Last imported at : Jan. 12, 2022, 9 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 2040, "treatment_name": "Gabapentin", "treatment_type": "Central nervous system agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]