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Probiotics
Probiotics for Coronavirus (PROVID-LD Trial)
N/A
Waitlist Available
Led By Jean-Charles Pasquier, MD, PhD
Research Sponsored by Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14,30 and 90 days after the covid-19 diagnosis.
Awards & highlights
PROVID-LD Trial Summary
This trial aims to see if probiotics can help reduce the number of patients with long COVID by 25% 90 days after diagnosis.
Eligible Conditions
- Coronavirus
- COVID-19
PROVID-LD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 14,30 and 90 days after the covid-19 diagnosis.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14,30 and 90 days after the covid-19 diagnosis.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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
Secondary outcome measures
Compare the proportion of patients presenting COVID-19 symptoms and severity of symptoms at D14, D30 and D90 by taking probiotics during the acute phase of COVID-19.
Describe the symptoms severity and evolution by study group and baseline characteristics.
Determine/identify prognostic factors measured at baseline (inclusion) associated with LONG-COV (sociodemographic, clinical factors).
PROVID-LD Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ProbioticsExperimental Treatment1 Intervention
Two probiotic strains will constitute the experimental arm (Probiotics). Participants will take two capsules per day (one closed capsule to swallow and one open capsule mixed with maple syrup) for 10 days and one closed capsule per day to swallow for the following 15 days. They will stop the treatment if they are admitted to the hospital. The treatment will last a maximum of 25 days.
Group II: PlaceboPlacebo Group1 Intervention
Potato starch and magnesium stearate will constitute the comparator arm (Placebo). Participants will take two capsules per day (one closed capsule to swallow and one open capsule mixed with maple syrup) for 10 days and one closed capsule per day to swallow for the following 15 days. They will stop the treatment if they are admitted to the hospital. The treatment will last a maximum of 25 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Probiotics
2017
Completed Phase 4
~3350
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Who is running the clinical trial?
Centre de recherche du Centre hospitalier universitaire de SherbrookeLead Sponsor
58 Previous Clinical Trials
30,547 Total Patients Enrolled
Lallemand Health SolutionsIndustry Sponsor
39 Previous Clinical Trials
3,101 Total Patients Enrolled
Jean-Charles Pasquier, MD, PhDPrincipal InvestigatorCIUSSSE-CHUS
8 Previous Clinical Trials
734 Total Patients Enrolled
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