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Please consider this website is continuously evolving and still under development
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| Column | Value |
|---|---|
| Trial registration number | NCT04621071 |
|
Full text link
Last imported at : Nov. 10, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : Nov. 1, 2021, noon Source : ClinicalTrials.gov |
|
|
Contact
Last imported at : Nov. 1, 2021, noon Source : ClinicalTrials.gov |
Audrey Hamel-Thibault, audrey.hamel-thibault@usherbrooke.ca (PI email not reported) |
|
Registration date
Last imported at : Nov. 10, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2020-11-09 |
|
Recruitment status
Last imported at : Nov. 1, 2021, noon Source : ClinicalTrials.gov |
Completed |
|
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 |
Parallel |
|
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. 10, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
inclusion criteria: - first positive test for covid-19 in the last 5 days; - having symptoms of the covid-19 at enrollment; - self-caring at home; - living in quebec for the next 60 days; - able to take medication alone; - with access to a phone or to the internet; - able to give informed consent. |
|
Exclusion criteria
Last imported at : Nov. 10, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
- taking probiotic supplements at enrollment; - taking antibiotics for a reason other than covid-19 at enrollment; - allergies to soy, lactose, yeast, maltodextrin, vitamin c, potato starch, magnesium stearate, hypromellose or titanium dioxide; - has a chronically weakened immune system (aids, lymphoma, chemo-radio- corticosteroid therapy, immunosuppressive pathology); - was treated with chemo-radio-corticosteroid therapy in the last 6 months; - has active cancer; - taking immunosuppressive drugs (e.g. anti-rejection treatment after organ transplant); - already participating in another clinical trial; - is pregnant, expects to become pregnant in the next few months or is breastfeeding; - has any other condition that would prevent safe participation in the study. |
|
Number of arms
Last imported at : Nov. 10, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2 |
|
Funding
Last imported at : Nov. 10, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Centre de recherche du Centre hospitalier universitaire de Sherbrooke |
|
Inclusion age min
Last imported at : Nov. 10, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : Nov. 10, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
100 |
|
Countries
Last imported at : Nov. 10, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Canada |
|
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 : Nov. 1, 2021, noon Source : ClinicalTrials.gov |
17 |
|
primary outcome
Last imported at : Nov. 10, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Duration of symptoms of the COVID-19 |
|
Notes
Last imported at : Nov. 10, 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 : Nov. 10, 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"}] |