POPCORN: COVID-19 Platform Prospective Cohort Study
This overarching study aims to follow children across their entire healthcare trajectory to advance our understanding of children that present to the emergency department (ED) and/or are admitted to the hospital for severe acute SARS-CoV-2 infections, multisystem inflammatory syndrome (MIS-C), myocarditis, and pericarditis and detect signals of emerging syndromes in children.
The specific aims of this study are;
* To evaluate the short and long-term clinical outcomes and health consequences among children diagnosed with acute COVID-19 illness and their families, compared to SARS-CoV-2 negative controls and their families.
* To evaluate the predictors (or risk factors) for severe disease and poor outcomes (hospitalization, critical illness, and mortality), from COVID-19 by comparing characteristics of children with/without COVID-19 who do and do not experience severe outcomes.
* To compare the short- and long-term outcomes and health consequences among children with myocarditis, pericarditis and MIS-C occurring as a) adverse events following SARS-CoV-2 immunization (AEFIs) and b) as complications of SARS-CoV-2 infection and to assess consequences for their families.
* To examine equity considerations in COVID-19 acute disease, events following vaccination, and long-term outcomes by applying social and structural determinants of health lens including but not limited to analyses based on race/ethnicity/Indigenous identity, immigration status, gender, LGBTQIA2S+ identity, language, disabilities, and household income level.
* To collect biological samples from patients with confirmed MIS-C, myocarditis, and pericarditis following SARS-CoV-2 vaccination or infection and appropriate, matched controls for biobanking and later inclusion in national and international studies into the causes and risk factors of AEFIs and MIS-C (Translational sub-study). Additionally, samples will be collected from unmatched controls.
Overview
- Acronym
- POPCORN-COVID-19
- Website
- POPCORN-COVID-19
- Investigators
-
- Contacts
General Design
- Study design
- Cohort
- Start - End Year
- 2023 - 2024
- General Information on Follow Up (profile, frequency)
-
* All the participants are followed up at 1 week, 2 months, 6 months and 12 months after baseline. * The follow-up "date" varies depending on the date the patient became eligible for the study.
- Recruitment Target
-
- Individuals
- Number of Participants
- No Limit
- Number of Participants with Biological Samples
- No Limit
- Supplementary information about number of participants
-
Recruitment is ongoing.
Access
Availability of data and biosamples
| Possible Access to Data | |
| Possible Access to Biosamples | |
| Other |
|
Timeline
Populations
POPCORN-COVID-19 - SARS-CoV-2 positive - Case
The population is composed of children under 18 years of age who tested positive for SARS-CoV-2 infection by reverse transcription-polymerase chain reaction (RT-PCR Test) or equivalent and presenting with acute COVID-19-like symptoms.
Selection Criteria
- Maximum age
-
17
- Countries
-
- Canada
- Canadian Provinces
-
- Alberta
- British Columbia
- Manitoba
- Newfoundland and Labrador
- Nova Scotia
- Ontario
- Quebec
- Saskatchewan
- Health Status
-
- Paricipants are included in the the study if they; * Presented or admitted to a participating pediatric ED, inpatient ward, or Pediatric Intensive Care Unit. * Presented with one or more COVID-19 compatible symptoms (respiratory, febrile young infant <60 days, gastrointestinal, other). * If they tested for SARS-CoV-2 infection.
- Supplementary Information about selection criteria
-
Participants may consent to the biobank as a biobank control.
Sources of Recruitment
- Specific Population
-
- Clinic patients
- Supplementary Information
-
Paricipants are recruited across 16 academic pediatric institutions which are BC Children’s Hospital (Vancouver), Stollery Children’s Hospital (Edmonton), Alberta Children’s Hospital (Calgary), Jim Pattison Children’s Hospital (Saskatoon), The Children’s Hospital of Winnipeg (Winnipeg), McMaster Children’s Hospital (Hamilton), The Hospital for Sick Children (Toronto), Kingston Health Sciences Centre (Kingston), Children’s Hospital of Eastern Ontario (Ottawa), Children's Hospital London Health Sciences Centre (London), Montreal Children’s Hospital (Montreal), CHU Sainte-Justine (Montreal), CHU de Sherbrooke (Sherbrooke), CHU de Quebec l‘Université de Laval (Quebec City), Janeway Children’s Health and Rehabilitation Centre (St. John’s), and IWK Health Centre (Halifax).
Sample Size
- Number of Participants
- 2,000
Data Collection Events
| # | Name | Data sources | Data sources - Biosamples | Start | End |
|---|---|---|---|---|---|
| 0 | POPCORN-COVID-19 - SARS-CoV-2 positive Case - Baseline |
|
2023 (January) | 2024 (March) | |
| 1 | POPCORN-COVID-19 - SARS-CoV-2 positive Case - First follow-up (0 to 9 days) |
|
2023 (January) | 2024 (March) | |
| 2 | POPCORN-COVID-19 - SARS-CoV-2 positive Case - Second follow-up (2 months) |
|
2023 (March) | 2024 (March) | |
| 4 | POPCORN-COVID-19 - SARS-CoV-2 positive Case - Third follow-up (6 months) |
|
2023 (July) | 2024 (March) | |
| 5 | POPCORN-COVID-19 - SARS-CoV-2 positive Case - Fourth follow-up (12 months) |
|
2024 (January) | 2024 (March) |
POPCORN-COVID-19 - SARS-CoV-2 positive incidental - Case
The population is composed of children under 18 years of age who tested positive for SARS-CoV-2 infection by reverse transcription-polymerase chain reaction (RT-PCR Test) or equivalent and did not present with acute COVID-19-like symptoms.
Selection Criteria
- Maximum age
-
17
- Countries
-
- Canada
- Canadian Provinces
-
- Alberta
- British Columbia
- Manitoba
- Newfoundland and Labrador
- Nova Scotia
- Ontario
- Quebec
- Saskatchewan
- Health Status
-
- Paricipants are included in the the study if they; * Presented or admitted to a participating pediatric ED, inpatient ward, or Pediatric Intensive Care Unit. * If they tested for SARS-CoV-2 infection.
- Supplementary Information about selection criteria
-
Participants were enrolled but not matched to controls.
Sources of Recruitment
- Specific Population
-
- Clinic patients
- Supplementary Information
-
Paricipants are recruited across 16 academic pediatric institutions which are BC Children’s Hospital (Vancouver), Stollery Children’s Hospital (Edmonton), Alberta Children’s Hospital (Calgary), Jim Pattison Children’s Hospital (Saskatoon), The Children’s Hospital of Winnipeg (Winnipeg), McMaster Children’s Hospital (Hamilton), The Hospital for Sick Children (Toronto), Kingston Health Sciences Centre (Kingston), Children’s Hospital of Eastern Ontario (Ottawa), Children's Hospital London Health Sciences Centre (London), Montreal Children’s Hospital (Montreal), CHU Sainte-Justine (Montreal), CHU de Sherbrooke (Sherbrooke), CHU de Quebec l‘Université de Laval (Quebec City), Janeway Children’s Health and Rehabilitation Centre (St. John’s), and IWK Health Centre (Halifax).
Sample Size
- Number of Participants
- No Limit
- Supplementary information about number of participants
-
As of September 2023, the total number of participants is 9. There is no limit to the number of participants that can be recruited for this population.
Data Collection Events
| # | Name | Data sources | Data sources - Biosamples | Start | End |
|---|---|---|---|---|---|
| 0 | POPCORN-COVID-19 - SARS-CoV-2 positive incidental Case - Baseline |
|
2023 (January) | 2024 (March) | |
| 1 | POPCORN-COVID-19 - SARS-CoV-2 positive incidental Case - First follow-up (0 to 9 days) |
|
2023 (January) | 2024 (March) | |
| 2 | POPCORN-COVID-19 - SARS-CoV-2 positive incidental Case - Second follow-up (2 months) |
|
2023 (March) | 2024 (March) | |
| 3 | POPCORN-COVID-19 - SARS-CoV-2 positive incidental Case - Third follow-up (6 months) |
|
2023 (July) | 2024 (March) | |
| 4 | POPCORN-COVID-19 - SARS-CoV-2 positive incidental Case - Fourth follow-up (12 months) |
|
2024 (January) | 2024 (March) |
POPCORN-COVID-19 - SARS-CoV-2 negative - Control
The population is composed of children under 18 years of age who are pediatric ED patients or inpatient ward units with acute non-febrile or mild febrile illness, accidental injury, or outpatients requiring bloodwork for other reasons and who tested negative for SARS-CoV-2 infection by reverse transcription-polymerase chain reaction (RT-PCR) or equivalent and presenting with acute COVID-19-like symptoms.
Selection Criteria
- Maximum age
-
17
- Countries
-
- Canada
- Canadian Provinces
-
- Alberta
- British Columbia
- Manitoba
- Newfoundland and Labrador
- Nova Scotia
- Ontario
- Quebec
- Saskatchewan
- Health Status
-
- Participants are included if they tested for SARS-CoV-2 infection. Presented symptoms related other respiratory infectious syndromes (e.g., respiratory syncytial virus, influenza), febrile young infant < 60 days, gastrointestinal symptoms – including hepatitis, and others (e.g., neurological)).
- Supplementary Information about selection criteria
-
Participants consented to the biobank only as a biobank control.
Sources of Recruitment
- Specific Population
-
- Clinic patients
- Supplementary Information
-
* Paricipants are recruited across 16 academic pediatric institutions which are BC Children’s Hospital (Vancouver), Stollery Children’s Hospital (Edmonton), Alberta Children’s Hospital (Calgary), Jim Pattison Children’s Hospital (Saskatoon), The Children’s Hospital of Winnipeg (Winnipeg), McMaster Children’s Hospital (Hamilton), The Hospital for Sick Children (Toronto), Kingston Health Sciences Centre (Kingston), Children’s Hospital of Eastern Ontario (Ottawa), Children's Hospital London Health Sciences Centre (London), Montreal Children’s Hospital (Montreal), CHU Sainte-Justine (Montreal), CHU de Sherbrooke (Sherbrooke), CHU de Quebec l‘Université de Laval (Quebec City), Janeway Children’s Health and Rehabilitation Centre (St. John’s), and IWK Health Centre (Halifax).
Sample Size
- Number of Participants
- 4,000
Data Collection Events
| # | Name | Data sources | Data sources - Biosamples | Start | End |
|---|---|---|---|---|---|
| 0 | POPCORN-COVID-19 - SARS-CoV-2 negative Control - Baseline |
|
2023 (January) | 2024 (March) | |
| 1 | POPCORN-COVID-19 - SARS-CoV-2 negative Control - First follow-up (0 to 9 days) |
|
2023 (January) | 2024 (March) | |
| 2 | POPCORN-COVID-19 - SARS-CoV-2 negative Control - Second follow-up (2 months) |
|
2023 (March) | 2024 (March) | |
| 4 | POPCORN-COVID-19 - SARS-CoV-2 negative Control - Third follow-up (6 months) |
|
2023 (July) | 2024 (March) | |
| 5 | POPCORN-COVID-19 - SARS-CoV-2 negative Control - Fourth follow-up (12 months) |
|
2024 (January) | 2024 (March) |
POPCORN-COVID-19 - Myocarditis and Pericarditis - Case
The population is composed of children under 18 years of age with clinical criteria consistent with myocarditis or pericarditis presenting to the ED or participating pediatric institution to be assessed by a physician.
Selection Criteria
- Maximum age
-
17
- Countries
-
- Canada
- Canadian Provinces
-
- Alberta
- British Columbia
- Manitoba
- Newfoundland and Labrador
- Nova Scotia
- Ontario
- Quebec
- Saskatchewan
- Health Status
-
- Paricipants are included in the the study if they; * Presented or admitted to a participating pediatric ED, inpatient ward, or Pediatric Intensive Care Unit. * Diagnostic bloodwork for Myocarditis and Pericarditis was ordered or expected to be ordered based on assessment by triage or admitting teams. * Activation of a myocarditis or pericarditis clinical pathway * Another known cause for the child’s presentation determined prior to blood draw
- Supplementary Information about selection criteria
-
Participants may consent to the biobank as a biobank case.
Sources of Recruitment
- Specific Population
-
- Clinic patients
- Supplementary Information
-
Paricipants are recruited across 16 academic pediatric institutions which are BC Children’s Hospital (Vancouver), Stollery Children’s Hospital (Edmonton), Alberta Children’s Hospital (Calgary), Jim Pattison Children’s Hospital (Saskatoon), The Children’s Hospital of Winnipeg (Winnipeg), McMaster Children’s Hospital (Hamilton), The Hospital for Sick Children (Toronto), Kingston Health Sciences Centre (Kingston), Children’s Hospital of Eastern Ontario (Ottawa), Children's Hospital London Health Sciences Centre (London), Montreal Children’s Hospital (Montreal), CHU Sainte-Justine (Montreal), CHU de Sherbrooke (Sherbrooke), CHU de Quebec l‘Université de Laval (Quebec City), Janeway Children’s Health and Rehabilitation Centre (St. John’s), and IWK Health Centre (Halifax).
Sample Size
- Number of Participants
- 100
- Number of Participants with Biological Samples
- 50
Data Collection Events
| # | Name | Data sources | Data sources - Biosamples | Start | End |
|---|---|---|---|---|---|
| 0 | POPCORN-COVID-19 - Myocarditis and Pericarditis Case - Baseline |
|
|
2023 (January) | 2024 (March) |
| 1 | POPCORN-COVID-19 - Myocarditis and Pericarditis Case - First follow-up (0 to 9 days) |
|
2023 (January) | 2024 (March) | |
| 2 | POPCORN-COVID-19 - Myocarditis and Pericarditis Case - Second follow-up (2 months) |
|
|
2023 (March) | 2024 (March) |
| 4 | POPCORN-COVID-19 - Myocarditis and Pericarditis Case - Third follow-up (6 months) |
|
|
2023 (July) | 2024 (March) |
| 5 | POPCORN-COVID-19 - Myocarditis and Pericarditis Case - Fourth follow-up (12 months) |
|
2024 (January) | 2024 (March) |
POPCORN-COVID-19 - Myocarditis and Pericarditis - Control
The population is composed of children under 18 years of age who are pediatric ED patients or inpatient ward units with acute non-febrile or mild febrile illness, accidental injury, or outpatients requiring bloodwork for other reasons and who have a recent history of COVID-19 vaccination (past 30 days) or with clinical criteria consistent with myocarditis or pericarditis cases but, upon assessment by a physician, did not receive the diagnosis.
Selection Criteria
- Maximum age
-
17
- Countries
-
- Canada
- Canadian Provinces
-
- Alberta
- British Columbia
- Manitoba
- Newfoundland and Labrador
- Nova Scotia
- Ontario
- Quebec
- Saskatchewan
- Health Status
-
- Paricipants are included in the the study if they; * Presented or admitted to a participating pediatric ED, inpatient ward, or Pediatric Intensive Care Unit. * Diagnostic bloodwork for Myocarditis and pericarditis was ordered or expected to be ordered based on assessment by triage or admitting teams however, an alternate diagnosis was determined, or investigations were normal.
- Supplementary Information about selection criteria
-
Participants consented to the biobank only as a biobank control.
Sources of Recruitment
- Specific Population
-
- Clinic patients
- Supplementary Information
-
Paricipants are recruited across 16 academic pediatric institutions which are BC Children’s Hospital (Vancouver), Stollery Children’s Hospital (Edmonton), Alberta Children’s Hospital (Calgary), Jim Pattison Children’s Hospital (Saskatoon), The Children’s Hospital of Winnipeg (Winnipeg), McMaster Children’s Hospital (Hamilton), The Hospital for Sick Children (Toronto), Kingston Health Sciences Centre (Kingston), Children’s Hospital of Eastern Ontario (Ottawa), Children's Hospital London Health Sciences Centre (London), Montreal Children’s Hospital (Montreal), CHU Sainte-Justine (Montreal), CHU de Sherbrooke (Sherbrooke), CHU de Quebec l‘Université de Laval (Quebec City), Janeway Children’s Health and Rehabilitation Centre (St. John’s), and IWK Health Centre (Halifax).
Sample Size
- Number of Participants
- 100
- Number of Participants with Biological Samples
- 200
Data Collection Events
| # | Name | Data sources | Data sources - Biosamples | Start | End |
|---|---|---|---|---|---|
| 0 | POPCORN-COVID-19 - Myocarditis and Pericarditis Control - Baseline |
|
|
2023 (January) | 2024 (March) |
| 1 | POPCORN-COVID-19 - Myocarditis and Pericarditis Control - First follow-up (0 to 9 days) |
|
2023 (January) | 2024 (March) | |
| 2 | POPCORN-COVID-19 - Myocarditis and Pericarditis Control - Second follow-up (2 months) |
|
|
2023 (March) | 2024 (March) |
| 4 | POPCORN-COVID-19 - Myocarditis and Pericarditis Control - Third follow-up (6 months) |
|
|
2023 (July) | 2024 (March) |
| 5 | POPCORN-COVID-19 - Myocarditis and Pericarditis Control - Fourth follow-up (12 months) |
|
2024 (January) | 2024 (March) |
POPCORN-COVID-19 - MIS-C - Case
The population is composed of children under 18 years of age with clinical criteria consistent with MIS-C presenting to the ED or participating pediatric institution to be assessed by a physician.
Selection Criteria
- Countries
-
- Canada
- Canadian Provinces
-
- Alberta
- British Columbia
- Manitoba
- Newfoundland and Labrador
- Nova Scotia
- Ontario
- Quebec
- Saskatchewan
- Health Status
-
- Paricipants are included in the the study if they; * Presented or admitted to a participating pediatric ED, inpatient ward, or PICU * Fever in last 24 hours * Activation of a MIS-C clinical pathway * Another known cause for the child’s presentation determined prior to blood draw * Diagnostic bloodwork for MIS-C was ordered or expected to be ordered based on assessment by triage or admitting teams
- Supplementary Information about selection criteria
-
Participants may consent to the biobank as a biobank case.
Sources of Recruitment
- Specific Population
-
- Clinic patients
- Supplementary Information
-
Paricipants are recruited across 16 academic pediatric institutions which are BC Children’s Hospital (Vancouver), Stollery Children’s Hospital (Edmonton), Alberta Children’s Hospital (Calgary), Jim Pattison Children’s Hospital (Saskatoon), The Children’s Hospital of Winnipeg (Winnipeg), McMaster Children’s Hospital (Hamilton), The Hospital for Sick Children (Toronto), Kingston Health Sciences Centre (Kingston), Children’s Hospital of Eastern Ontario (Ottawa), Children's Hospital London Health Sciences Centre (London), Montreal Children’s Hospital (Montreal), CHU Sainte-Justine (Montreal), CHU de Sherbrooke (Sherbrooke), CHU de Quebec l‘Université de Laval (Quebec City), Janeway Children’s Health and Rehabilitation Centre (St. John’s), and IWK Health Centre (Halifax).
Sample Size
- Number of Participants
- 300
- Number of Participants with Biological Samples
- 150
Data Collection Events
| # | Name | Data sources | Data sources - Biosamples | Start | End |
|---|---|---|---|---|---|
| 0 | POPCORN-COVID-19 - MIS-C Case - Baseline |
|
|
2023 (January) | 2024 (March) |
| 1 | POPCORN-COVID-19 - MIS-C Case - First follow-up (0 to 9 days) |
|
2023 (January) | 2024 (March) | |
| 2 | POPCORN-COVID-19 - MIS-C Case - Second follow-up (2 months) |
|
|
2023 (March) | 2024 (March) |
| 4 | POPCORN-COVID-19 - MIS-C Case - Third follow-up (6 months) |
|
|
2023 (July) | 2024 (March) |
| 5 | POPCORN-COVID-19 - MIS-C Case - Fourth follow-up (12 months) |
|
2024 (January) | 2024 (March) |
POPCORN-COVID-19 - MIS-C - Control
The population is composed of children under 18 years of age who are pediatric ED patients or inpatient ward units with acute non-febrile or mild febrile illness, accidental injury, or outpatients requiring bloodwork for other reasons and who have a recent history of COVID-19 vaccination (past 30 days) or with clinical criteria consistent with MIS-C cases but, upon assessment by a physician, did not receive the diagnosis.
Selection Criteria
- Maximum age
-
17
- Countries
-
- Canada
- Canadian Provinces
-
- Alberta
- British Columbia
- Manitoba
- Nova Scotia
- Ontario
- Quebec
- Saskatchewan
- Health Status
-
- Paricipants are included in the the study if they; * Presented or admitted to a participating pediatric ED, inpatient ward, or PICU * Fever in last 24 hours * Diagnostic bloodwork for MIS-C was ordered or expected to be ordered based on assessment by triage or admitting teams however, an alternate diagnosis was determined, or investigations were normal. * Another known cause for the child’s presentation determined prior to blood draw
- Supplementary Information about selection criteria
-
Participants consented to the biobank only as a biobank control.
Sources of Recruitment
- Specific Population
-
- Clinic patients
- Supplementary Information
-
Paricipants are recruited across 16 academic pediatric institutions which are BC Children’s Hospital (Vancouver), Stollery Children’s Hospital (Edmonton), Alberta Children’s Hospital (Calgary), Jim Pattison Children’s Hospital (Saskatoon), The Children’s Hospital of Winnipeg (Winnipeg), McMaster Children’s Hospital (Hamilton), The Hospital for Sick Children (Toronto), Kingston Health Sciences Centre (Kingston), Children’s Hospital of Eastern Ontario (Ottawa), Children's Hospital London Health Sciences Centre (London), Montreal Children’s Hospital (Montreal), CHU Sainte-Justine (Montreal), CHU de Sherbrooke (Sherbrooke), CHU de Quebec l‘Université de Laval (Quebec City), Janeway Children’s Health and Rehabilitation Centre (St. John’s), and IWK Health Centre (Halifax).
Sample Size
- Number of Participants
- 300
- Number of Participants with Biological Samples
- 200
Data Collection Events
| # | Name | Data sources | Data sources - Biosamples | Start | End |
|---|---|---|---|---|---|
| 0 | POPCORN-COVID-19 - MIS-C Control - Baseline |
|
|
2023 (January) | 2024 (March) |
| 1 | POPCORN-COVID-19 - MIS-C Control - First follow-up (0 to 9 days) |
|
2023 (January) | 2024 (March) | |
| 2 | POPCORN-COVID-19 - MIS-C Control - Second follow-up (2 months) |
|
|
2023 (March) | 2024 (March) |
| 4 | POPCORN-COVID-19 - MIS-C Control - Third follow-up (6 months) |
|
|
2023 (July) | 2024 (March) |
| 5 | POPCORN-COVID-19 - MIS-C Control - Fourth follow-up (12 months) |
|
2024 (January) | 2024 (March) |
Participating Studies
| Acronym | Name | Study design | Countries |
|---|
Harmonization Initiatives Included
| Acronym | Name |
|---|
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: 2024-03-05T13:39:56.559