Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05080244 |
| Other study ID # |
2021-3700-ECR |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 28, 2021 |
| Est. completion date |
December 4, 2022 |
Study information
| Verified date |
November 2023 |
| Source |
Centre de recherche du Centre hospitalier universitaire de Sherbrooke |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Probiotics may be considered as an option of treatment for long COVID since they have
anti-viral effect, trigger immunomodulation and have low side-effects. This randomized
controlled trial aims to reduce the number of patients with long COVID by 25% 90 days after
the COVID-19 diagnosis by taking probiotics in a symptomatic population, self-caring at home.
During the acute phase of the disease, participants will take two capsules (probiotics or
placebo) per day for 10 days and one capsule (probiotics or placebo) per day for the
following 15 days. A follow-up will be done twice during the acute phase, 14 days and 28 days
after starting to take the investigational product (compliance to treatment, side effects,
etc.). At inclusion and at Day14, Day30 and Day90 after the COVID-19 diagnosis, a
questionnaire will be administered (COVID-19 symptoms, anxiety, functioning difficulties,
etc.) and 2 saliva and 2 stool (viral and microbiota analyzes) self-samples will be
performed.
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.
