COVID-19PERN-COVID-19NCT04330261
Clinical Characteristics and Outcomes of Pediatric COVID-19
An observational study of COVID-19 and SARS-CoV-2 Infection, run by University of Calgary at 1 site in Canada.
Trial summary
Rationale: The clinical manifestations of SARS-CoV-2 infection in children are poorly characterized. Preliminary findings indicate that they may be atypical. There is a need to identify the spectrum of clinical presentations, predictors of severe disease (COVID-19) outcomes, and successful treatment strategies in this… Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- COVID-19, SARS-CoV-2 Infection, Pediatric ALL
- What is being tested?
- Exposure (not intervention) - SARS-CoV-2 infection
- How many people
- 10,610 participants
- Where
- 1 siteCanada
- Study dates
- 18 Mar 2020to 5 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: All children presenting to a participating ED who are screened (i.e. tested) for SARS-CoV-2 during the duration of the study. Children will be mainly from urban areas across Canada, United States of America, Italy, Spain, Australia, New Zealand, Argentina, Singapore, and other countries.
Who may be able to join
- < 18 years-old, and
- Present to a participating ED for care, and
- Undergo SARS-CoV-2 testing.
Who cannot join
- 1) Refusal to participate (no informed consent)
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of Calgary/Alberta Children's Hospital
Calgary, Alberta, T3B 6A8
About this study
Official title: Clinical Characteristics and Outcomes of Children Potentially Infected by Severe Acute Respiratory Distress Syndrome (SARS)-CoV-2 Presenting to Pediatric Emergency Departments
Rationale: The clinical manifestations of SARS-CoV-2 infection in children are poorly characterized. Preliminary findings indicate that they may be atypical. There is a need to identify the spectrum of clinical presentations, predictors of severe disease (COVID-19) outcomes, and successful treatment strategies in this population.
Goals:
Read more
Primary - Describe and compare characteristics of confirmed SARS-CoV-2 infected children with symptomatic test-negative children.
Secondary - 1) Describe and compare confirmed SARS-CoV-2 infected children with mild versus severe COVID-19 outcomes; 2) Describe healthcare resource utilization for, and outcomes of, screening and care of pediatric COVID-19 internationally, alongside regional public health policy changes.
Methods: This prospective observational study will occur in 50 emergency departments across 11 countries. We will enroll 12,500 children who meet institutional screening guidelines and undergo SARS-CoV-2 testing. Data collection focuses on epidemiological risk factors, demographics, signs, symptoms, interventions, laboratory testing, imaging, and outcomes. Collection will occur at enrollment, 14 days, and 90 days.
Timeline: Recruitment will last for 12 months (worst-case model) and will begin within 7-14 days of funding notification after ongoing expedited review of ethics and data sharing agreements.
Impact: Results will be shared in real-time with key policymakers, enabling rapid evidence-based adaptations to pediatric case screening and management.
Read the detailed description
Pediatric COVID-19: The characteristics of pediatric 2019 novel coronavirus disease (COVID-19) are not yet well understood. Preliminary findings indicate that atypical presentations of COVID-19 occur in children. Thus, there is an urgent need to identify risk factors for pediatric COVID-19 infection, the range of clinical manifestations, predictors of severe outcomes, and successful treatment strategies.
Objectives: Primary: To contribute to the optimization of medical countermeasures to pediatric COVID-19 through describing and comparing the clinical characteristics of SARS-CoV-2 infected children (i.e. test positive) with children who were screened for SARS-CoV-2 but tested negative. We will also describe and compare SARS-CoV-2 infected children with mild versus those with severe outcomes. This study will also describe the health care resources utilized for screening, isolation, and care of pediatric COVID-19, examined alongside relevant public health policies.
Methods: This is a two-year prospective observational study that will take place at 50 EDs across 19 countries. We will enroll children (<18 years old) presenting to participating study EDs who meet institutional screening guidelines and undergo testing for COVID-19. Data collection is aligned with WHO templates and focuses on epidemiological factors, demographics, signs, symptoms, exposures, interventions, and test results. Collection will occur at the time of enrolment, during the course of illness, at hospital discharge (if admitted), and at two weeks and three months following enrolment. Over a period of 18 months (starting March 31st, 2020) we aim to enroll and complete follow-up for a total of 5000 children with screened for suspected SARS-CoV-2 infection. Data will be entered into a centralized database, and analyzed using simple and multiple ordinal logistic regression models. Data will be interpreted alongside detailed, prospectively collected, information on the changes to case isolation, screening, and management policies that occur throughout the epidemic in each institution and study region.
Feasibility: The Pediatric Emergency Research Networks (PERN) represents the largest international acute pediatric care collaboration in the world, including more than 200 hospitals across 35 countries. Currently, PERN is carrying out the PERN-Pneumonia prospective cohort study, designed to identify predictors of severe pneumonia at 70 hospitals around the globe, including at eight Canadian pediatric emergency departments (ED). This study will build onto the PERN-Pneumonia study infrastructure (e.g. ethics approvals, data sharing agreements, research teams) in order to facilitate a unique, rapid, and global response to the COVID-19 epidemic. Feasibility is enhanced by our design - we will not interfere with the existing COVID-19 screening and management procedures in-place in study EDs; we will not collect any biological specimens, and will not prescribe any interventions.
Project Team: This international multidisciplinary team includes pediatric emergency medicine and infectious disease clinicians, epidemiologists, statisticians, and public health leaders from around the globe. Team members have led many landmark trials in pediatric emergency medicine, and lead large pediatric research networks and studies including the PERN-Pneumonia study. They also came together to study the H1N1 pandemic and identified predictors of severe outcomes. Team members also have expertise in pediatric lower respiratory tract infections, biostatistics, and epidemiology (including the CDC lead on the MERS-CoV outbreak). This study team also includes the Public Health Agency of Canada's senior medical/technical expert on COVID-19.
Impact of the research: The results of this study, which will be shared in real-time with appropriate national and international authorities, will enable policymakers to make rapid evidence-based adaptations to case screening and management procedures that will then allow for the earlier identification of children likely to have confirmed infection with COVID-19 as well as to prioritize those children likely to have severe outcomes. Finally, the establishment of this global multi-site study will be the first trial of a rapid PERN networks response to a pandemic novel respiratory virus, which, applying lessons-learned, can be urgently reactivated for future public health emergencies.
- Being tested
- Exposure (not intervention) - SARS-CoV-2 infection
- Medical subject headings
- COVID-19, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Pneumonia, Viral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure (not intervention) - SARS-CoV-2 infectionOther
Exposure is infection with the virus. There is no intervention
| Study group | Role | What they receive |
|---|---|---|
| SARS-CoV-2 Positive Children | All children screened for SARS-CoV-2 and presenting to participating sites will be enrolled in this study. Children who are eventually test-positive for SARS-CoV-2 will be considered the exposed group in this study. These children will have exactly the same prospective follow-up as the other group. Receives: Other: Exposure (not intervention) - SARS-CoV-2 infection | |
| SARS-CoV-2 Negative Children | All children screened for SARS-CoV-2 and presenting to participating sites will be enrolled in this study. Children who are eventually test-negative for SARS-CoV-2 will be considered the unexposed (control) group in this study. These children will have exactly the same prospective follow-up as the other group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical characteristics of children with SARS-CoV-2
Clinical characteristics among children presenting to a participating hospital's EDs who meet each site's local SARS-CoV-2 screening criteria, will be described and compared between children with confirmed SARS-CoV-2 (i.e. test-positive) versus suspected (i.e. test-negative) infections.
Measured: 18 months
Factors associated with severe COVID-19 outcomes
Factors associated with severe outcomes [i.e. positive pressure ventilation (invasive or noninvasive) OR intensive care unit admission with ventilatory or inotropic support OR death; other outcomes may be added as the understanding of the epidemic evolves) will be identified in confirmed paediatric COVID-19 cases.
Measured: 18 months
Secondary outcomes (2)
Health care resource utilization for COVID-19 patient management
Health care resource utilization for patient management (e.g. frequencies of isolation, laboratory testing, imaging, and supportive care, with associated costs) of both suspected and confirmed SARS-CoV-2 infected children according to changes in national and regional policies.
Measured: 18 months
Sensitivity and specificity of COVID-19 case screening policies
The sensitivity and specificity of various case screening policies for the detection of confirmed symptomatic SARS-CoV-2 infection (i.e. COVID-19) in children (e.g. addition of vomiting/diarrhoea).
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2020
- Study start18 Mar 2020
- Primary completion15 Jun 2021
- Study completion5 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,610 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen Freedman, MD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04330261
- Sponsor's protocol ID
- REB18-0107
- Acronym
- PERN-COVID-19
- Status last verified
- May 2022
- First submitted
- 30 Mar 2020
- Last updated
- 17 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: In keeping with the joint statement on sharing research data and findings relevant to the novel coronavirus (nCoV) outbreak, this study will share data rapidly with local governments as well as international stakeholders.
Publications
Funk AL, Florin TA, Dalziel SR, Mintegi S, Salvadori MI, Tancredi DJ, Neuman MI, Payne DC, Plint AC, Klassen TP, Malley R, Ambroggio L, Kim K, Kuppermann N, Freedman SB. Prospective cohort study of children with suspected SARS-CoV-2 infection presenting to paediatric emergency departments: a Paediatric Emergency Research Networks (PERN) Study Protocol. BMJ Open. 2021 Jan 15;11(1):e042121. doi: 10.1136/bmjopen-2020-042121.
PubMed 33452195
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Characteristics and Outcomes of Children Potentially Infected by Severe Acute Respiratory Distress Syndrome (SARS)-CoV-2 Presenting to Pediatric Emergency Departments
- ClinicalTrials.gov ID
- NCT04330261
- Acronym / sponsor ID
- PERN-COVID-19 / REB18-0107
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10,610 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 18 Mar 2020 (actual)
- Primary completion
- 15 Jun 2021 (actual)
- Study completion
- 5 Apr 2022 (actual)
- First posted
- 1 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Rationale: The clinical manifestations of SARS-CoV-2 infection in children are poorly characterized. Preliminary findings indicate that they may be atypical. There is a need to identify the spectrum of clinical presentations, predictors of severe disease (COVID-19) outcomes, and successful treatment strategies in this population.
Goals:
Primary - Describe and compare characteristics of confirmed SARS-CoV-2 infected children with symptomatic test-negative children.
Secondary - 1) Describe and compare confirmed SARS-CoV-2 infected children with mild versus severe COVID-19 outcomes; 2) Describe healthcare resource utilization for, and outcomes of, screening and care of pediatric COVID-19 internationally, alongside regional public health policy changes.
Methods: This prospective observational study will occur in 50 emergency departments across 11 countries. We will enroll 12,500 children who meet institutional screening guidelines and undergo SARS-CoV-2 testing. Data collection focuses on epidemiological risk factors, demographics, signs, symptoms, interventions, laboratory testing, imaging, and outcomes. Collection will occur at enrollment, 14 days, and 90 days.
Timeline: Recruitment will last for 12 months (worst-case model) and will begin within 7-14 days of funding notification after ongoing expedited review of ethics and data sharing agreements.
Impact: Results will be shared in real-time with key policymakers, enabling rapid evidence-based adaptations to pediatric case screening and management.
Detailed description
Pediatric COVID-19: The characteristics of pediatric 2019 novel coronavirus disease (COVID-19) are not yet well understood. Preliminary findings indicate that atypical presentations of COVID-19 occur in children. Thus, there is an urgent need to identify risk factors for pediatric COVID-19 infection, the range of clinical manifestations, predictors of severe outcomes, and successful treatment strategies.
Objectives: Primary: To contribute to the optimization of medical countermeasures to pediatric COVID-19 through describing and comparing the clinical characteristics of SARS-CoV-2 infected children (i.e. test positive) with children who were screened for SARS-CoV-2 but tested negative. We will also describe and compare SARS-CoV-2 infected children with mild versus those with severe outcomes. This study will also describe the health care resources utilized for screening, isolation, and care of pediatric COVID-19, examined alongside relevant public health policies.
Methods: This is a two-year prospective observational study that will take place at 50 EDs across 19 countries. We will enroll children (<18 years old) presenting to participating study EDs who meet institutional screening guidelines and undergo testing for COVID-19. Data collection is aligned with WHO templates and focuses on epidemiological factors, demographics, signs, symptoms, exposures, interventions, and test results. Collection will occur at the time of enrolment, during the course of illness, at hospital discharge (if admitted), and at two weeks and three months following enrolment. Over a period of 18 months (starting March 31st, 2020) we aim to enroll and complete follow-up for a total of 5000 children with screened for suspected SARS-CoV-2 infection. Data will be entered into a centralized database, and analyzed using simple and multiple ordinal logistic regression models. Data will be interpreted alongside detailed, prospectively collected, information on the changes to case isolation, screening, and management policies that occur throughout the epidemic in each institution and study region.
Feasibility: The Pediatric Emergency Research Networks (PERN) represents the largest international acute pediatric care collaboration in the world, including more than 200 hospitals across 35 countries. Currently, PERN is carrying out the PERN-Pneumonia prospective cohort study, designed to identify predictors of severe pneumonia at 70 hospitals around the globe, including at eight Canadian pediatric emergency departments (ED). This study will build onto the PERN-Pneumonia study infrastructure (e.g. ethics approvals, data sharing agreements, research teams) in order to facilitate a unique, rapid, and global response to the COVID-19 epidemic. Feasibility is enhanced by our design - we will not interfere with the existing COVID-19 screening and management procedures in-place in study EDs; we will not collect any biological specimens, and will not prescribe any interventions.
Project Team: This international multidisciplinary team includes pediatric emergency medicine and infectious disease clinicians, epidemiologists, statisticians, and public health leaders from around the globe. Team members have led many landmark trials in pediatric emergency medicine, and lead large pediatric research networks and studies including the PERN-Pneumonia study. They also came together to study the H1N1 pandemic and identified predictors of severe outcomes. Team members also have expertise in pediatric lower respiratory tract infections, biostatistics, and epidemiology (including the CDC lead on the MERS-CoV outbreak). This study team also includes the Public Health Agency of Canada's senior medical/technical expert on COVID-19.
Impact of the research: The results of this study, which will be shared in real-time with appropriate national and international authorities, will enable policymakers to make rapid evidence-based adaptations to case screening and management procedures that will then allow for the earlier identification of children likely to have confirmed infection with COVID-19 as well as to prioritize those children likely to have severe outcomes. Finally, the establishment of this global multi-site study will be the first trial of a rapid PERN networks response to a pandemic novel respiratory virus, which, applying lessons-learned, can be urgently reactivated for future public health emergencies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SARS-CoV-2 Positive Children | – | Other: Exposure (not intervention) - SARS-CoV-2 infectionAll children screened for SARS-CoV-2 and presenting to participating sites will be enrolled in this study. Children who are eventually test-positive for SARS-CoV-2 will be considered the exposed group in this study. These children will have exactly the same prospective follow-up as the other group. |
| SARS-CoV-2 Negative Children | – | –All children screened for SARS-CoV-2 and presenting to participating sites will be enrolled in this study. Children who are eventually test-negative for SARS-CoV-2 will be considered the unexposed (control) group in this study. These children will have exactly the same prospective follow-up as the other group. |
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All children presenting to a participating ED who are screened (i.e. tested) for SARS-CoV-2 during the duration of the study. Children will be mainly from urban areas across Canada, United States of America, Italy, Spain, Australia, New Zealand, Argentina, Singapore, and other countries.
Key inclusion criteria (3 listed)
- < 18 years-old, and
- Present to a participating ED for care, and
- Undergo SARS-CoV-2 testing.
Key exclusion criteria (1 listed)
- 1) Refusal to participate (no informed consent)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exposure (not intervention) - SARS-CoV-2 infectionExposure is infection with the virus. There is no intervention | Other | SARS-CoV-2 Positive Children |
Primary outcome
Clinical characteristics of children with SARS-CoV-2
Time frame: 18 months
Clinical characteristics among children presenting to a participating hospital's EDs who meet each site's local SARS-CoV-2 screening criteria, will be described and compared between children with confirmed SARS-CoV-2 (i.e. test-positive) versus suspected (i.e. test-negative) infections.
Factors associated with severe COVID-19 outcomes
Time frame: 18 months
Factors associated with severe outcomes [i.e. positive pressure ventilation (invasive or noninvasive) OR intensive care unit admission with ventilatory or inotropic support OR death; other outcomes may be added as the understanding of the epidemic evolves) will be identified in confirmed paediatric COVID-19 cases.
2 secondary outcomes
Health care resource utilization for COVID-19 patient management
Time frame: 18 months
Sensitivity and specificity of COVID-19 case screening policies
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
- Derived from this study: PubMed 33452195Funk AL, Florin TA, Dalziel SR, Mintegi S, Salvadori MI, Tancredi DJ, Neuman MI, Payne DC, Plint AC, Klassen TP, Malley R, Ambroggio L, Kim K, Kuppermann N, Freedman SB. Prospective cohort study of children with suspected SARS-CoV-2 infection presenting to paediatric emergency departments: a Paediatric Emergency Research Networks (PERN) Study Protocol. BMJ Open. 2021 Jan 15;11(1):e042121. doi: 10.1136/bmjopen-2020-042121.
- Individual participant dataSharing planned: Yes. In keeping with the joint statement on sharing research data and findings relevant to the novel coronavirus (nCoV) outbreak, this study will share data rapidly with local governments as well as international stakeholders.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Freedman, MD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and SARS-CoV-2 Infection, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical characteristics of children with SARS-CoV-2 (time frame: 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04330261, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2022.