COVID-19 trials registries data warehouse

 Return to trial list

Trial - NCT04409873


Column Value
Trial registration number NCT04409873
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04409873

First author
Last imported at : Oct. 1, 2022, 6:30 a.m.
Source : ClinicalTrials.gov

None

Contact
Last imported at : Oct. 1, 2022, 6:30 a.m.
Source : ClinicalTrials.gov

None

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

2020-06-01

Recruitment status
Last imported at : Nov. 19, 2023, noon
Source : ClinicalTrials.gov

Terminated

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 : May 8, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

inclusion criteria: - tested positive for covid-19 with a sample collected in the prior 7 days - ability to read and speak english or spanish - ability to participate in the study for 4 weeks - being asymptomatic or having mild or moderate symptoms (for example, sore throat, coughing, fever, fatigue) - ability to rinse/gargle - not having any condition that might worsen with gargling solutions - not having a history of mouthwash sensitivity - not having an allergy to any mouthwash that has been used before - not using another mouthwash/gargling solution since the most recent positive test - not taking antimicrobial medications (antibacterial, antiviral, antibiotics including off-label fda-approved medications such as hydroxychloroquine) - anticipated ability to participate in the study for 4 weeks - have a cellphone and agree to receive text messages for reminders to use mouthwash during the day and for follow-up visits, and can videoconference (like zoom) on a cellphone, tablet, or computer for sample collection instructions

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

- people who because of their symptoms intend to receive antiviral medications that could potentially affect viral load in their saliva samples - pregnant or lactating women due to potential aversions to mouthwash solution taste/smell.

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

5

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

University of California, San Francisco

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

No restriction on type of patients

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

0: No restriction on type of patients

Total sample size
Last imported at : Oct. 1, 2022, 6:30 a.m.
Source : ClinicalTrials.gov

54

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

Change in SARS-Cov-2 viral load

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 2

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

[{"arm_notes": "", "treatment_id": 277, "treatment_name": "Chlorine dioxide", "treatment_type": "Mouthwash", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 268, "treatment_name": "Cetylpyridinium chloride", "treatment_type": "Mouthwash", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 606, "treatment_name": "Hydrogen peroxide", "treatment_type": "Mouthwash", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1865, "treatment_name": "Listerine zero", "treatment_type": "Mouthwash", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]