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Efficacy of Probiotics in Reducing Duration and Symptoms of COVID-19 (PROVID-19)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04621071
Recruitment Status : Recruiting
First Posted : November 9, 2020
Last Update Posted : January 19, 2021
Sponsor:
Collaborator:
Lallemand Health Solutions
Information provided by (Responsible Party):
Centre de recherche du Centre hospitalier universitaire de Sherbrooke

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.


Condition or disease Intervention/treatment Phase
COVID-19 Dietary Supplement: Probiotics (2 strains 10x10^9 UFC) Dietary Supplement: Placebo (potato starch and magnesium stearate) Not Applicable

Detailed Description:

Rational: COVID-19 disease is caused by a new coronavirus (SARS-CoV-2) and has received worldwide attention. No specific antiviral treatment is recommended for COVID-19 and no vaccine is currently available so far. Several strong arguments support the study of probiotics for COVID-19: 1) probiotics act on viruses by various well described mechanisms (reduction of absorption, cellular internalization of the virus, production of metabolites / substances having a direct antiviral effect; and immunomodulation); 2) probiotics are considered with a high level of evidence (meta-analysis) to reduce diarrhea (associated with antibiotics and Clostridium difficile) and for respiratory tract infections; 3) probiotics are affordable and available with low side-effects.

Objectives:

  1. Evaluate the effect of probiotics on the duration of COVID-19 in symptomatic patients, with moderate forms of the disease.
  2. Evaluate the effect of probiotics on the severity of COVID-19 in symptomatic patients, with moderate forms of the disease.
  3. Evaluate the effect of probiotics on the evolution of oral and fecal microbiota in symptomatic patients, with moderate forms of the COVID-19 disease.

Population: Men and women, 18 years or older, with a first positive test for COVID-19 in the last 5 days, having symptoms of the COVID-19, 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.

Material: After providing consent remotely (electronic or recorded by phone), patients will receive by mail at home: : a leaflet explaining the study, the study product (probiotics or placebo) for 25 days, a container of maple syrup and a cup, a thermometer, an oximeter, a logbook, 2 saliva sample self-collection kits, 2 stool sample self-collection kits and instruction sheets.

Randomization: Patients will be randomized in one of the study groups (stratified by age and gender). The randomization is double-blind and uses a ratio 1:1. Group A: will take probiotics for up to 25 days / Group B: will take placebo for up to 25 days.

Follow-up: Upon inclusion in the study, the participant will complete a questionnaire that will focus on socio-demographic (age, marital status), medical (weight, height, general health, current medication, symptoms…), food intake and other relevant information. The participants will fill a daily booklet evaluating their symptoms, compliance to treatment, medication intake, temperature, oxygen saturation value, etc. For those who will be admitted to hospital, data on their admission, complications and treatments will be collected. At 55 days after their enrollment, will fill an end of study questionnaire (symptoms, satisfaction, well-being, etc.).

Samples: The study includes the optional collection of saliva and stool samples twice, on Day 1 (before the first product is taken) and on Day 10.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of the Efficacy of Probiotics to Reduce the Duration and Symptoms of COVID-19 (PROVID-19 Study): a Randomized, Double-blind, Controlled Trial
Estimated Study Start Date : January 5, 2021
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Probiotics
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)
Probiotic vs Placebo (1:1)

Placebo Comparator: Placebo
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)
Probiotic vs Placebo (1:1)




Primary Outcome Measures :
  1. Duration of symptoms of the COVID-19 [ Time Frame: During the period of the treatment (from Day 1 to Day 25) ]
    Number of days before symptoms disappear


Secondary Outcome Measures :
  1. Severity of the COVID-19 [ Time Frame: 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) ]
    Categorical distribution among: 1) at home without symptoms, 2) at home with symptoms, 3) hospitalized without O2 supplementation, 4) hospitalized with O2 supplementation, 5) admitted to intensive care unit, 6) deceased

  2. Evolution of oral and fecal microbiota [ Time Frame: At Day 1 (baseline) and Day 10 of the treatment ]
    Metagenomic sequencing



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04621071


Contacts
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Contact: Audrey Hamel-Thibault, MSc 819-346-1110 ext 12865 audrey.hamel-thibault@usherbrooke.ca
Contact: Blanche Senicourt, PhD Blanche.Senicourt@USherbrooke.ca

Locations
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Canada, Quebec
CIUSSS de L'Estrie-CHUS Hospital Recruiting
Sherbrooke, Quebec, Canada, J1H 5N4
Contact: Audrey Hamel-Thibault, MSc    8193461110 ext 12865    Audrey.Hamel-Thibault@USherbrooke.ca   
Contact: Blanche Senicourt, PhD       Blanche.Senicourt@USherbrooke.ca   
Principal Investigator: Jean-Charles Pasquier, MD, PhD         
Sponsors and Collaborators
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Lallemand Health Solutions
Investigators
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Principal Investigator: Jean-Charles Pasquier, Dr CIUSSSE-CHUS
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Responsible Party: Centre de recherche du Centre hospitalier universitaire de Sherbrooke
ClinicalTrials.gov Identifier: NCT04621071    
Other Study ID Numbers: 2021-3700
First Posted: November 9, 2020    Key Record Dates
Last Update Posted: January 19, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre de recherche du Centre hospitalier universitaire de Sherbrooke:
covid
sars-cov-2
coronavirus