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Trial - NCT04621149


Column Value
Trial registration number NCT04621149
Full text link
Last imported at : Nov. 10, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04621149

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 : Nov. 10, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2020-11-09

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

Terminated

Study design
Last imported at : Nov. 10, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Nov. 10, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Nov. 10, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Factorial

Masking
Last imported at : Nov. 10, 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 : Nov. 10, 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: signed and dated informed consent form stated willingness to comply with all study procedures and availability for the duration of the study male or female, aged 20-70 confirmed diagnosis of covid-19 by positive covid-19 test. symptoms of a mild degree such that hospitalization is not required. within 7 days of symptom onset. ability to drink at least 1 liter of water daily and be willing to adhere to the study regimen

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

covid-19 symptoms of a severe enough nature that requires hospitalization pregnancy or lactation diagnosis of diabetes mellitus currently taking paroxetine or digoxin individuals with diabetes mellitus

Number of arms
Last imported at : Nov. 10, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

8

Funding
Last imported at : Nov. 10, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Profact, Inc.

Inclusion age min
Last imported at : Nov. 10, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

20

Inclusion age max
Last imported at : Nov. 10, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

70

Countries
Last imported at : Dec. 30, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

United States

Type of patients
Last imported at : Nov. 10, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Mild disease at enrollment

Severity scale
Last imported at : Nov. 10, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

1: Mild disease at enrollment

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

10

primary outcome
Last imported at : Nov. 10, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Reduction in Participant Symptoms of COVID-19

Notes
Last imported at : Nov. 10, 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 : Nov. 10, 2020, 11:31 p.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": 1398, "treatment_name": "Zinc acetate", "treatment_type": "Vitamins and dietary supplements", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1504, "treatment_name": "Famotidine+green tea extract+lactoferrin", "treatment_type": "Others pharmacological treatment+vitamins and dietary supplements", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1506, "treatment_name": "Famotidine+green tea extract+lactoferrin+zinc acetate", "treatment_type": "Others pharmacological treatment+vitamins and dietary supplements", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1734, "treatment_name": "Chlorine dioxide+zinc acetate", "treatment_type": "Mouthwash+vitamins and dietary supplements", "pharmacological_treatment": "Non pharmacological treatment+pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1505, "treatment_name": "Chlorine dioxide+famotidine+green tea extract+lactoferrin", "treatment_type": "Mouthwash+others pharmacological treatment+vitamins and dietary supplements", "pharmacological_treatment": "Non pharmacological treatment+pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1507, "treatment_name": "Chlorine dioxide+famotidine+green tea extract+lactoferrin+zinc acetate", "treatment_type": "Mouthwash+others pharmacological treatment+vitamins and dietary supplements", "pharmacological_treatment": "Non pharmacological treatment+pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]