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Trial - NCT04458519


Column Value
Trial registration number NCT04458519
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

First author
Last imported at : June 3, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Martin Y Desrosiers, MD

Contact
Last imported at : June 3, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

desrosiers_martin@hotmail.com

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

2020-07-07

Recruitment status
Last imported at : June 3, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Completed

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 : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

inclusion criteria: - males and females aged 18-59 years - positive diagnosis of covid-19 infection less than 96 hours - characteristic respiratory symptoms present but no more than mild to moderate - no need for oxygen - temperature less than 38.0 ºc - not presently being considered for hospitalisation or icu admission - able to perform nasal irrigation - able to provide consent - able to communicate with the study team by phone, text or email

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

- patients with pre-existing conditions or demographic features placing them at increased risk of complications from covid10 infection will not be included in this study. these will be considered exclusion factors, thus individuals will be questioned as to the presence or these factors during their telephone screening. - respiratory disorders: - asthma, pre-existing copd, bronchiectasis or cystic fibrosis - hypertension - cardiovascular disease: - rhythm disturbances, recent (less than 6 months), angina pectoris cardiac insufficiency - diabetes - immunosuppressed patients (other than covid-19 induced) - primary immune deficiencies such as hypogammaglobulinemia or common variable immune deficiency (cvid) - chemotherapy depressing the immune system - immune suppressing medications such as prednisone, imuran, or tnf inhibitors, or anti-rejection transplant drugs. - solid organ transplant - cancer under treatment or within five years (except basocellular skin cancers) - pregnant or breastfeeding women or women unwilling to practice contraception as outlined in the study protocol for the duration of the study period. - allergy to milk or its derivatives

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

2

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

Centre hospitalier de l'Université de Montréal (CHUM)

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

59

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

Canada

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

Mild disease at enrollment

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

1: Mild disease at enrollment

Total sample size
Last imported at : June 3, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

23

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

Change in severity of COVID-19 infection

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

None

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

Not reported

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

[{"arm_notes": "", "treatment_id": 1022, "treatment_name": "Probiotics", "treatment_type": "Microbiota intervention", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]