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Trial - NCT04610801


Column Value
Trial registration number NCT04610801
Full text link
Last imported at : Nov. 3, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04610801

First author
Last imported at : Oct. 8, 2021, 12:30 p.m.
Source : ClinicalTrials.gov

Roboam R Aguirre, MD, DBA

Contact
Last imported at : Oct. 8, 2021, 12:30 p.m.
Source : ClinicalTrials.gov

raguirre@larkinhospital.com

Registration date
Last imported at : Nov. 3, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2020-11-02

Recruitment status
Last imported at : Oct. 8, 2021, 12:30 p.m.
Source : ClinicalTrials.gov

Not recruiting

Study design
Last imported at : Nov. 3, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Nov. 3, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Nov. 3, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Crossover

Masking
Last imported at : Nov. 3, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Blind label

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

multi-center

Study aim
Last imported at : Nov. 3, 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: adults of ages 18 to 90 years of both sexes with positive sars-cov-2 carriage confirmed by nasopharyngeal pcr signed informed consent 1- mild symptoms: minimum respiratory symptoms or asymptomatic plus positive test 2- moderate symptoms: respiratory symptoms such as cough, mild shortness of breath with mild oxygen desaturation(room air spo2 <92% and >88% or <88% corrected to >92% with 2lt of oxygen)

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

patient with very low viral load (threshold cycle [ct] > 25 per pcr). known hypersensitivity to one of the constituents, particularly to xylitol or gse under 18 years of age women of childbearing age who are pregnant, breastfeeding mothers, and intend to become pregnant during the study period; unwilling/unable to take a pregnancy test. unable to provide informed consent or decline to consent or unwillingness to adhere to the standard of care protocol. patients with severe symptoms -hypoxia (spo2 <88% not corrected by 2 liter non-concentrated oxygen) plus severe shortness of breath history of immunodeficiency or are currently receiving immunosuppressive therapy. have had a planned surgical procedure within the past 12 weeks. already part of this trial, recruited at a different hospital. patient unable to perform oro-nasopharyngeal decolonization patients with acute exacerbation of severe comorbidities like heart disorders chronic obstructive pulmonary disease (copd), heart failure new york heart association (nyha) class 3 and 4 and/or diseases with severe oxygenation problems patients on remdesivir and/or other clinical trials.

Number of arms
Last imported at : Nov. 3, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

3

Funding
Last imported at : Nov. 3, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Larkin Community Hospital

Inclusion age min
Last imported at : Nov. 3, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Nov. 3, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

90

Countries
Last imported at : Nov. 3, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

United States

Type of patients
Last imported at : Nov. 3, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Moderate/severe disease at enrollment

Severity scale
Last imported at : Nov. 3, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

4: Moderate/severe disease at enrollment

Total sample size
Last imported at : Nov. 3, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

200

primary outcome
Last imported at : Nov. 3, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Change from baseline reactive to non-reactive on COVID 19 RT PCR in 7 days

Notes
Last imported at : Nov. 3, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

None

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

Phase 3

Arms
Last imported at : Nov. 3, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 1394, "treatment_name": "Xylitol", "treatment_type": "Nutrition", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]