NCT04621071

Brief Summary

COVID-19 disease caused by a new coronavirus (SARS-CoV-2) has received worldwide attention. No specific antiviral treatment is recommended for COVID-19 and no vaccine is currently available. Probiotics may be considered as an option of treatment since they have anti-viral effect, trigger immunomodulation and have low side-effects. This randomized controlled trial aims to evaluate the efficacy of probiotics to reduce the duration and symptoms of COVID-19 in a symptomatic population tested positive to SARS-CoV-2, self-caring at home.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable covid19

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 5, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 9, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

January 12, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 19, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 12, 2021

Completed
Last Updated

October 29, 2021

Status Verified

October 1, 2021

Enrollment Period

7 months

First QC Date

November 5, 2020

Last Update Submit

October 28, 2021

Conditions

COVID-19

Keywords

covidsars-cov-2coronavirus

Outcome Measures

Primary Outcomes (1)

  • Duration of symptoms of the COVID-19

    Number of days before symptoms disappear

    During the period of the treatment (from Day 1 to Day 25)

Secondary Outcomes (2)

  • Severity of the COVID-19

    During the period of the study, first day in (at randomization) to last day in (last follow-up 30 days after the end of treatment) (from Day 1 to Day 55)

  • Evolution of oral and fecal microbiota

    At Day 1 (baseline) and Day 10 of the treatment

Study Arms (2)

Probiotics

EXPERIMENTAL

Two probiotic strains will constitute the experimental arm (Probiotics). Patients will take two capsules a day (one closed capsule to swallow and one open capsule mixed with maple syrup) from Day 1 to Day 10 and one closed capsule to swallow from Day 11 to Day 25.They will stop the treatment if they are admitted to the hospital. The treatment will last a maximum of 25 days.

Dietary Supplement: Probiotics (2 strains 10x10^9 UFC)

Placebo

PLACEBO COMPARATOR

Potato starch and magnesium stearate will constitute the comparator arm (Placebo). Patients will take two capsules a day (one closed capsule to swallow and one open capsule mixed with maple syrup) from Day 1 to Day 10 and one closed capsule to swallow from Day 11 to Day 25.They will stop the treatment if they are admitted to the hospital. The treatment will last a maximum of 25 days.

Dietary Supplement: Placebo (potato starch and magnesium stearate)

Interventions

Probiotics (2 strains 10x10^9 UFC)DIETARY_SUPPLEMENT

Probiotic vs Placebo (1:1)

Probiotics
Placebo (potato starch and magnesium stearate)DIETARY_SUPPLEMENT

Probiotic vs Placebo (1:1)

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CIUSSS de L'Estrie-CHUS Hospital

Sherbrooke, Quebec, J1H 5N4, Canada

Location

MeSH Terms

Conditions

COVID-19Coronavirus Infections

Interventions

Probioticsstearic acid

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Jean-Charles Pasquier, Dr

    CIUSSSE-CHUS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2020

First Posted

November 9, 2020

Study Start

January 12, 2021

Primary Completion

August 19, 2021

Study Completion

October 12, 2021

Last Updated

October 29, 2021

Record last verified: 2021-10

Locations

CA(1)