COVID-19PROVID-19NCT04621071
Efficacy of Probiotics in Reducing Duration and Symptoms of COVID-19
A study testing Probiotics (2 strains 10x10^9 UFC) in people with COVID-19, run by Centre de recherche du Centre hospitalier universitaire de Sherbrooke at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Probiotics (2 strains 10x10^9 UFC)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteCanada
- Study dates
- 12 Jan 2021to 12 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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:
- Evaluate the effect of probiotics on the duration of COVID-19 in symptomatic patients, with moderate forms of the disease.
- Evaluate the effect of probiotics on the severity of COVID-19 in symptomatic patients, with moderate forms of the disease.
- 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.
- Conditions
- COVID-19
- Being tested
- Probiotics (2 strains 10x10^9 UFC), Placebo (potato starch and magnesium stearate)
- Keywords
- covid, sars-cov-2, coronavirus
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotics (2 strains 10x10^9 UFC)Dietary supplement
Probiotic vs Placebo (1:1)
Placebo (potato starch and magnesium stearate)Dietary supplement
Probiotic vs Placebo (1:1)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Placebo (potato starch and magnesium stearate) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of symptoms of the COVID-19
Number of days before symptoms disappear
Measured: During the period of the treatment (from Day 1 to Day 25)
Secondary outcomes (2)
Severity of the COVID-19
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
Measured: 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
Metagenomic sequencing
Measured: At Day 1 (baseline) and Day 10 of the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2020
- Study start12 Jan 2021
- Primary completion19 Aug 2021
- Study completion12 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre de recherche du Centre hospitalier universitaire de Sherbrooke
- Sponsor type
- University, hospital or other
- Collaborators
- Lallemand Health Solutions
- Responsible party
- Sponsor
- Investigators
- Jean-Charles Pasquier, Dr, Principal investigator, CIUSSSE-CHUS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04621071
- Sponsor's protocol ID
- 2021-3700
- Acronym
- PROVID-19
- Status last verified
- Oct 2021
- First submitted
- 5 Nov 2020
- Last updated
- 29 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04621071
- Acronym / sponsor ID
- PROVID-19 / 2021-3700
- Conditions
- COVID-19
- Keywords
- covid, sars-cov-2, coronavirus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Centre de recherche du Centre hospitalier universitaire de SherbrookeUniversity, hospital or other
- Collaborators
- Lallemand Health Solutions
- Study start
- 12 Jan 2021 (actual)
- Primary completion
- 19 Aug 2021 (actual)
- Study completion
- 12 Oct 2021 (actual)
- First posted
- 9 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- Evaluate the effect of probiotics on the duration of COVID-19 in symptomatic patients, with moderate forms of the disease.
- Evaluate the effect of probiotics on the severity of COVID-19 in symptomatic patients, with moderate forms of the disease.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotics | Experimental | Dietary Supplement: Probiotics (2 strains 10x10^9 UFC)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. |
| Placebo | Placebo comparator | Dietary Supplement: Placebo (potato starch and magnesium stearate)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotics (2 strains 10x10^9 UFC)Probiotic vs Placebo (1:1) | Dietary supplement | Probiotics |
| Placebo (potato starch and magnesium stearate)Probiotic vs Placebo (1:1) | Dietary supplement | Placebo |
Primary outcome
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
2 secondary outcomes
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)
Evolution of oral and fecal microbiota
Time frame: At Day 1 (baseline) and Day 10 of the treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Charles Pasquier, Dr principal investigator
CIUSSSE-CHUS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotics (2 strains 10x10^9 UFC) in people with COVID-19, run by Centre de recherche du Centre hospitalier universitaire de Sherbrooke at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of symptoms of the COVID-19 (time frame: During the period of the treatment (from Day 1 to Day 25)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2021.