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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 |
|
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"}] |