IPCO: Identification of Microbial Factors to Modulate Immune Dysregulation and Treat Post-COVID-19 Syndrome
The objective of this substudy is to identify microbial communities and/or metabolites that can be used to improve immune dysregulation and treat complications associated with OSC/PCS.
This objective will be attain by completing the following Specific Aims:
* Aim 1: Identify intestinal microbiome and metabolomic signatures that distinguish patients with and without long COVID.
* Aim 2: Determine whether intestinal microbial translocation into systemic circulation can distinguish patients with long COVID.
* Aim 3: Evaluate systemic inflammation and immune dysregulation in patients with and without long COVID
Identification of the Microbial Factors to Modulate Immune Dysregulation and Treat Post-COVID Syndrome is a substudy of the IPCO project whose primary objectives are to evaluate the short- and long-term end-organ complications post-COVID-19 in relation to the severity of the acute COVID-19 infection and establish a post-COVID-19 biobank.
Overview
- Acronym
- IPCO-MF
- Website
- IPCO-MF
- Investigators
-
- Contacts
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General Design
- Study design
- Cohort
- Start - End Year
- 2021 - 2025
- General Information on Follow Up (profile, frequency)
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Stool from the COVID positive group and the COVID negative group was collected at inclusion visit, 12 month-visit and 24 month-visit.
- Recruitment Target
-
- Individuals
- Number of Participants
- 570
Access
Availability of data and biosamples
| Possible Access to Data | |
| Possible Access to Biosamples | |
| Other |
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Supplementary Information
Hypothesis: acute SARS-CoV2 infection induces intestinal dysbiosis which leads to intestinal barrier dysfunction resulting in microbial and/or metabolite translocation from the intestine into systemic circulation. Translocated microbes and/or their metabolites impact systemic inflammation and immune regulation, thereby protecting against or leading to end-organ complications associated with long COVID.
Timeline
Populations
IPCO-MF - COVID-19 positive
The population is composed of individuals who had previous asymptomatic or mild COVID-19 (ie.never required supplemental oxygen during the acute phase of the infection), individuals who had previous moderate or severe COVID-19 (moderate: required supplemental oxygen by nasal cannula during the acute phase of the infection; severe: required supplemental oxygen by either high-flow nasal cannula, non-invasive positive pressure ventilation or intubation) and individuals who had COVID-19 but did not have signs or symptoms related to COVID-19 lasting beyond 4 weeks from the date of COVID-19 symptom-onset or diagnosis including essential workers, household members of patients with confirmed COVID-19, patients followed at IRCM clinic or by collaborative physicians, patients hospitalized at CHUM on a COVID-19 protocol (i.e. FRQS BioBank), participants enrolled in the Quebec Action for Post-COVID (QAPC) study, and other COVID-19 positive persons who have heard about the study or have seen an advertisement.
Selection Criteria
- Minimum age
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18
- Countries
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- Canada
- Canadian Provinces
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- Quebec
- Health Status
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- Inclusion criteria: COVID-19 positive PCR test or serology. In the absence of a positive COVID-19 test, the patient had symptoms consistent with COVID-19 while living with a person who had a confirmed positive COVID-19 test.
- Other Criteria
- Exclusion criteria: * Known pregnancy, no email address. Inclusion criteria: * Current resident of the province of Quebec.
Sources of Recruitment
- General Population
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- Volunteer enrolment
- Specific Population
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- Clinic patients
- Participants from Existing Studies
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- Quebec Action for Post-COVID (QAPC) study
- Supplementary Information
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Participants were recruited through:
Media or patient informed of the study by his doctor.
Electronic flyer emailed by human ressources (HR); CLSC, CHSLD, collaboration.
Publicity : Social networks, flyer, local journal, etc.
Electronic flyer or informations shared by household member.
Patient will be contacted by their treating physician at IRCM and offered enrollment into IPCO protocol if COVID-19 diagnosis previously confirmed or IRCM patients with immune defects or complex metabolic disorders who tested negative for COVID-19.
Patient will be contacted if they agreed on consent; FRQS network
Patients enrolled in Quebec Action for Post-COVID (QAPC) who accept to be referred for IPCO (this option will be included in the QAPC consent) .
Sample Size
- Number of Participants
- 520
- Supplementary information about number of participants
-
* Patients who had previous asymptomatic or mild COVID-19 (mild=never required supplemental oxygen during the acute phase of the infection) = 320 Participants * Patients who had previous moderate or severe COVID-19 (moderate=required supplemental oxygen by nasal cannula during the acute phase of the infection; severe=required supplemental oxygen by either high-flow nasal cannula, non-invasive positive pressure ventilation or intubation = 100 Participants * Patients who had COVID-19 but did not have signs or symptoms related to COVID-19 lasting beyond 4 weeks from the date of COVID-19 symptom-onset or diagnosis =100 Participants
Data Collection Events
| # | Name | Data sources | Data sources - Biosamples | Start | End |
|---|---|---|---|---|---|
| 0 | IPCO-MF - COVID-19 positive - Baseline |
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2021 (January) | Ongoing |
| 2 | IPCO-MF - COVID-19 positive - 12 months |
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|
2022 (January) | Ongoing |
| 4 | IPCO-MF - COVID-19 positive - 24 months |
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|
2023 (January) | Ongoing |
IPCO-MF - COVID-19 negative
The population is composed of individuals who have not had COVID-19 (i.e. patients who tested negative for COVID-19 and who never had symptoms consistent with COVID-19).
Selection Criteria
- Minimum age
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18
- Countries
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- Canada
- Canadian Provinces
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- Quebec
- Other Criteria
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Inclusion criteria: individual who tested negative for COVID-19 while living with a household member who tested positive for COVID-19 or individual who don’t have any COVID-19 related symptoms actually, never had tested positive and had at least one negative test.
Sources of Recruitment
- General Population
-
- Volunteer enrolment
- Specific Population
-
- Clinic patients
- Supplementary Information
-
Participants were recruited through: * Media or patient informed of the study by his doctor * Electronic flyer emailed by human ressources (HR); CLSC, CHSLD, collaboration * Publicity : Social networks, flyer, local journal, etc * Electronic flyer or informations shared by household member * Patient will be contacted if they agreed on consent; FRQS network
Sample Size
- Number of Participants
- 50
Data Collection Events
| # | Name | Data sources | Data sources - Biosamples | Start | End |
|---|---|---|---|---|---|
| 0 | IPCO-MF - COVID-19 negative - Baseline |
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2021 (January) | Ongoing |
| 1 | IPCO-MF - COVID-19 negative - 12 months |
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2022 (January) | Ongoing |
| 2 | IPCO-MF - COVID-19 negative - 24 months |
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2023 (January) | Ongoing |
Participating Studies
| Acronym | Name | Study design | Countries |
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Harmonization Initiatives Included
| Acronym | Name |
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Datasets
| Name | Data Collection Events | Variables |
|---|
Areas of Information Collected
- Socio-demographic and economic characteristics
- Death
- Lifestyle and behaviours
- Physical measures and assessments
- Birth, pregnancy and reproductive health history
- Laboratory measures
- Perception of health, quality of life, development and functional limitations
- Cognition, personality and psychological measures and assessments
- Diseases
- Life events, life plans, beliefs and values
- Symptoms and signs
- Preschool, school and work life
- Medication and supplements
- Social environment and relationships
- Non-pharmacological interventions
- Physical environment
- Health and community care services utilization
- Administrative information
Variables Content Summary
Areas of Information Collected
No Areas of Information Collected
No Scales Collected
Areas of Information Collected per per Population and Data Collection Event
No Areas of Information Collected
No Scales Collected
Networks
| Acronym | Name | Harmonization Initiatives | Individual Studies |
|---|
Last Update: 2024-02-27T14:30:02.737