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Trial - NCT05080244


Column Value
Trial registration number NCT05080244
Full text link
Last imported at : Oct. 16, 2021, 3 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT05080244

First author
Last imported at : Sept. 29, 2022, 6 a.m.
Source : ClinicalTrials.gov

None

Contact
Last imported at : Sept. 29, 2022, 6 a.m.
Source : ClinicalTrials.gov

None

Registration date
Last imported at : Oct. 16, 2021, 3 p.m.
Source : ClinicalTrials.gov

2021-10-15

Recruitment status
Last imported at : Feb. 13, 2023, 8:44 a.m.
Source : ClinicalTrials.gov

Completed

Study design
Last imported at : Oct. 16, 2021, 3 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Oct. 16, 2021, 3 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Oct. 16, 2021, 3 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Oct. 16, 2021, 3 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. 16, 2021, 3 p.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Oct. 16, 2021, 3 p.m.
Source : ClinicalTrials.gov

inclusion criteria: - 18 years and over - ≤ 10 days between the covid-19 diagnosis and the inclusion - having symptoms of the covid-19 at inclusion - living in quebec for the next 90 days - self-caring at home - able to take medication alone - with access to a phone or to the internet - able to give informed consent

Exclusion criteria
Last imported at : Oct. 16, 2021, 3 p.m.
Source : ClinicalTrials.gov

- taking probiotic supplements at inclusion - taking antibiotics for a reason other than covid-19 at inclusion - 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 randomized 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 : Oct. 16, 2021, 3 p.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Oct. 16, 2021, 3 p.m.
Source : ClinicalTrials.gov

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Inclusion age min
Last imported at : Oct. 16, 2021, 3 p.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Oct. 16, 2021, 3 p.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : Oct. 16, 2021, 3 p.m.
Source : ClinicalTrials.gov

Canada

Type of patients
Last imported at : Oct. 16, 2021, 3 p.m.
Source : ClinicalTrials.gov

Mild disease at enrollment

Severity scale
Last imported at : Oct. 16, 2021, 3 p.m.
Source : ClinicalTrials.gov

1: Mild disease at enrollment

Total sample size
Last imported at : Oct. 16, 2021, 3 p.m.
Source : ClinicalTrials.gov

618

primary outcome
Last imported at : Oct. 31, 2023, 4 p.m.
Source : ClinicalTrials.gov

Reduce by 25% the number of patients with LONG-COV during follow-up at D90 by taking probiotics during the acute phase of COVID-19

Notes
Last imported at : Oct. 16, 2021, 3 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. 16, 2021, 3 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"}]