- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05080244
WHO COVID-19 - Evaluation of the Efficacy of Probiotics to Reduce the Occurrence of Long COVID (PROVID-LD)
Evaluation of the Efficacy of Probiotics Taken During the Acute Phase of COVID-19 to Reduce the Occurrence of Long COVID
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Rational:
COVID-19 disease caused by a new coronavirus (SARS-CoV-2) has received worldwide attention. No effective treatment against COVID-19 is available and the current vaccination appears essential to control the pandemic. However, many questions remain, such as the durability of immunity and the appearance of variants. While the acute phase has been widely studied, the long-term consequences are unknown, and a new burden is emerging: the long COVID. The long COVID is defined by the persistence of symptoms of the disease for more than 4 weeks after diagnosis. 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 and 3) probiotics are affordable and available with low side-effects.
Objectives:
Primary objective: 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 objectives (Obj S):
Objective S1: 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.
Objective S2: Describe the symptoms severity and evolution by study group and baseline characteristics.
Objective S3: Determine/identify prognostic factors measured at baseline (inclusion) associated with LONG-COV (sociodemographic, clinical factors).
Population:
618 men and women, 18 years or older, with a first positive test for COVID-19 in the last 10 days, having symptoms of the COVID-19, self-caring at home, living in Quebec for the next 90 days, able to take medication alone, with access to a phone or to the Internet.
Randomization:
Patients will be randomized in one of the study groups (stratified by age and gender). The randomization is double-blinded and uses a ratio 1:1. Group A: will take probiotics for 25 days / Group B: will take placebo for 25 days.
Intervention:
During the acute phase of the disease, participants will take two capsules (probiotics or placebo) per day (one closed capsule to swallow and one open capsule mixed with maple syrup) for 10 days and one closed capsule (probiotics or placebo) per day to swallow for the following 15 days.
Data collection:
A follow-up will be done twice during the acute phase, 14 days and 28 days after starting to take the investigational product to evaluate compliance to treatment, medication intake, side effects, etc. At inclusion and at Day14, Day30 and Day90 after the COVID-19 diagnosis, the participant will complete a questionnaire that will focus on COVID-19 symptoms, food intake, anxiety, functioning difficulties, quality of life, etc. For those who will be admitted to hospital, data on their admission, complications and treatments will be collected.
Definition of LONG-COV:
The status of FLU-PRO and quality of life indicators before COVID-19 disease was initially unknown. Thus, we have operationalized the WHO's definition to select patients. If at least one of the criteria was met (see SAP for details), the participant would be qualified for an expert's review.
Every diagnosis based on Binomes was reviewed by expert on LONG-COV physicians. Those initially selected who potentially qualified for LONG-COV were called after the study to verify if symptoms were present or not before the positive detection of COVID-19. The final decision was on the expert physician responsibility.
Samples:
At inclusion and at Day14, Day30 and Day90 after the COVID-19 diagnosis, 2 saliva and 2 stool (viral and microbiota analyzes) self-samples will be performed.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Quebec
-
Sherbrooke, Quebec, Canada, J1H 5N4
- CIUSSS de l'Estrie-CHUS Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Probiotics
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.
|
2 strains 10x10^9 UFC/capsule
|
Placebo Comparator: Placebo
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.
|
Potato starch and magnesium stearate
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
Time Frame: 90 days after the COVID-19 diagnosis.
|
COVID-19 symptoms (FLU-PRO), anxiety (GAD-7) and functioning difficulties (WG-SS)
|
90 days after the COVID-19 diagnosis.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
Time Frame: 14,30 and 90 days after the COVID-19 diagnosis.
|
COVID-19 symptoms (FLU-PRO), anxiety (GAD-7) and functioning difficulties (WG-SS)
|
14,30 and 90 days after the COVID-19 diagnosis.
|
Describe the symptoms severity and evolution by study group and baseline characteristics.
Time Frame: Inclusion, Day14, Day30 and Day90 after the COVID-19 diagnosis
|
COVID-19 symptoms (FLU-PRO), baseline characteristics
|
Inclusion, Day14, Day30 and Day90 after the COVID-19 diagnosis
|
Determine/identify prognostic factors measured at baseline (inclusion) associated with LONG-COV (sociodemographic, clinical factors).
Time Frame: Inclusion, Day14, Day30 and Day90 after the COVID-19 diagnosis
|
COVID-19 symptoms (FLU-PRO), anxiety (GAD-7) and functioning difficulties (WG-SS), baseline characteristics
|
Inclusion, Day14, Day30 and Day90 after the COVID-19 diagnosis
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Jean-Charles Pasquier, MD, PhD, Ciussse-Chus
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- Disease Attributes
- Chronic Disease
- Post-Infectious Disorders
- COVID-19
- Post-Acute COVID-19 Syndrome
Other Study ID Numbers
- 2021-3700-ECR
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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