SARS CoV 2 InfectionNCT06640387
CARE-ID: Dynamics of Respiratory Infections in Children and Transmission in Households and Schools
An observational study of SARS CoV 2 Infection and RSV Infection, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
Viral respiratory tract infections are very common in children. They contribute to missed time in school, work disruption for caregivers and can also cause severe illness requiring hospitalization and rarely death. Read more about this study
- Who is it for?
- Ages 1 day and older
- Conditions the study is for
- SARS CoV 2 Infection, RSV Infection, Influenza
- What is being tested?
- Daily Influenza, RSV or SARS-CoV-2 PCR testing for 14 days
- How many people
- 500 participants
- Where
- 1 siteCanada
- Study dates
- 10 Oct 2024to 1 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 1 day and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Individuals with acute symptomatic influenza, RSV, SARS-CoV-2, mycoplasma pneumoniae, or bordetella pertussis infection identified through hospital testing (inpatient, outpatient, staff household members) or the school-based take-home saliva testing program.
Who may be able to join
- Viral dynamics (primary outcome):
- The child must be less than 18 years of age
- Have a positive PCR sample for influenza, RSV or SARS-CoV-2,
- Have any one of the symptoms listed to meet testing eligibility: fever, cough, shortness of breath, decreased or loss of taste or smell, muscle aches/joint pains (unusual, long lasting, not related to injury), extreme tiredness (unusual fatigue not otherwise explained), sore throat, runny or stuffy/congested nose, headache (new, unusual, long-lasting), nausea/vomiting and/or diarrhea, and
- Be within 5 days of symptom onset
- Household testing inclusion criteria (secondary outcome):
Show all 9Show fewer
- -Any individual in the same household (i.e. household contacts, defined as residing at the same address) as the individual testing positive by PCR for influenza, RSV, SARS-CoV-2, mycoplasma pneumoniae, or bordetella pertussis
- Classroom testing inclusion criteria (secondary outcome):
- -Any individual in the same classroom (i.e. classroom contacts) as the individual testing positive by PCR for influenza, RSV, SARS-CoV-2, mycoplasma pneumoniae, or bordetella pertussis (i.e. case identified through the THS program)
Who cannot join
- Viral dynamics (primary outcome):
- -Participants will be ineligible if they are more than 5 days from symptom onset
Trial locations and contacts
1 site in 1 country.
Canada1 site
The Hospital for Sick Children (SickKids)
Toronto, Ontario, M5G 1X8
About this study
Viral respiratory tract infections are very common in children. They contribute to missed time in school, work disruption for caregivers and can also cause severe illness requiring hospitalization and rarely death. In the 2022-2023, influenza, RSV and SARS-CoV-2 viruses infected a large number of children which strained the pediatric healthcare system in many jurisdictions. Unfortunately, there continues to be limited data on duration of infectiousness and transmission risk of these viruses to inform public health decisions during times when there is significant circulation of these viruses.
- Conditions
- SARS CoV 2 Infection, RSV Infection, Influenza, Mycoplasma Pneumoniae, Bordetella Pertussis, Whooping Cough
- Being tested
- Daily Influenza, RSV or SARS-CoV-2 PCR testing for 14 days
- Medical subject headings
- COVID-19, Respiratory Syncytial Virus Infections, Influenza, Human, Whooping Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily Influenza, RSV or SARS-CoV-2 PCR testing for 14 daysDiagnostic test
Each participant will undergo daily PCR testing for Influenza, RSV or SARS-CoV-2 to assess viral dynamics
What is being measured
The primary outcome is the main question the study is designed to answer.
To describe the viral dynamics of influenza, RSV and SARS-CoV-2 over time among children <18 years of age.
The correlation between symptom onset and symptom resolution and viral load for each virus will be described.
Measured: 14 days
Secondary outcomes (5)
To assess the impact of various host factors on viral dynamics
The correlation between host factors and viral dynamics will be explored.
Measured: 14 days
To assess the frequency of influenza, RSV, SARS-CoV-2, mycoplasma pneumoniae and bordetella pertussis transmission in households.
The number of household contacts that are tested and test positive for the same respiratory virus (influenza, RSV, SARS-CoV-2, mycoplasma pneumoniae, bordetella pertussis) will be described.
Measured: Within 14 days of case identification
To examine the risk factors for influenza, RSV, SARS-CoV-2, mycoplasma pneumoniae and bordetella pertussis transmission in households
The correlation between household characteristics and transmission of each of the viruses will be explored.
Measured: Within 14 days of case identification
To assess the frequency of influenza, RSV, SARS-CoV-2, mycoplasma pneumoniae and bordetella pertussis transmission in classrooms.
The number of classmates in the classroom that are tested and test positive for the same respiratory virus (influenza, RSV, SARS-CoV-2, mycoplasma pneumoniae, bordetella pertussis) will be described.
Measured: Within 14 days of case identification
To examine the risk factors for influenza, RSV, SARS-CoV-2, mycoplasma pneumoniae and bordetella pertussis transmission in classrooms
The correlation between classroom characteristics and transmission of each virus in classrooms will be explored.
Measured: Within 14 days of case identification
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start10 Oct 2024
- Primary completion2 Apr 2026
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS CoV 2 InfectionStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michelle Science, The Hospital for Sick Children
- Investigators
- Michelle Science, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06640387
- Sponsor's protocol ID
- 1000081729
- Status last verified
- Apr 2026
- First submitted
- 10 Oct 2024
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data elements will be made available by request with appropriate documentation and approvals.
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CARE-ID: Dynamics of Respiratory Infections in Children and Transmission in Households and Schools
- ClinicalTrials.gov ID
- NCT06640387
- Acronym / sponsor ID
- 1000081729
- Conditions
- SARS CoV 2 Infection, RSV Infection, Influenza, Mycoplasma Pneumoniae, Bordetella Pertussis, Whooping Cough
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- 10 Oct 2024 (actual)
- Primary completion
- 2 Apr 2026 (actual)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 15 Oct 2024 (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.
Viral respiratory tract infections are very common in children. They contribute to missed time in school, work disruption for caregivers and can also cause severe illness requiring hospitalization and rarely death. In the 2022-2023, influenza, RSV and SARS-CoV-2 viruses infected a large number of children which strained the pediatric healthcare system in many jurisdictions. Unfortunately, there continues to be limited data on duration of infectiousness and transmission risk of these viruses to inform public health decisions during times when there is significant circulation of these viruses.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Individuals with acute symptomatic influenza, RSV, SARS-CoV-2, mycoplasma pneumoniae, or bordetella pertussis infection identified through hospital testing (inpatient, outpatient, staff household members) or the school-based take-home saliva testing program.
Key inclusion criteria (9 listed)
- The child must be less than 18 years of age
- Have a positive PCR sample for influenza, RSV or SARS-CoV-2,
- Have any one of the symptoms listed to meet testing eligibility: fever, cough, shortness of breath, decreased or loss of taste or smell, muscle aches/joint pains (unusual, long lasting, not related to injury), extreme tiredness (unusual fatigue not otherwise explained), sore throat, runny or stuffy/congested nose, headache (new, unusual, long-lasting), nausea/vomiting and/or diarrhea, and
- Be within 5 days of symptom onset
- -Any individual in the same household (i.e. household contacts, defined as residing at the same address) as the individual testing positive by PCR for influenza, RSV, SARS-CoV-2, mycoplasma pneumoniae, or bordetella pertussis
Key exclusion criteria (2 listed)
- -Participants will be ineligible if they are more than 5 days from symptom onset
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 |
|---|---|---|
| Daily Influenza, RSV or SARS-CoV-2 PCR testing for 14 daysEach participant will undergo daily PCR testing for Influenza, RSV or SARS-CoV-2 to assess viral dynamics | Diagnostic test | – |
Primary outcome
To describe the viral dynamics of influenza, RSV and SARS-CoV-2 over time among children <18 years of age.
Time frame: 14 days
The correlation between symptom onset and symptom resolution and viral load for each virus will be described.
5 secondary outcomes
To assess the impact of various host factors on viral dynamics
Time frame: 14 days
To assess the frequency of influenza, RSV, SARS-CoV-2, mycoplasma pneumoniae and bordetella pertussis transmission in households.
Time frame: Within 14 days of case identification
To examine the risk factors for influenza, RSV, SARS-CoV-2, mycoplasma pneumoniae and bordetella pertussis transmission in households
Time frame: Within 14 days of case identification
To assess the frequency of influenza, RSV, SARS-CoV-2, mycoplasma pneumoniae and bordetella pertussis transmission in classrooms.
Time frame: Within 14 days of case identification
To examine the risk factors for influenza, RSV, SARS-CoV-2, mycoplasma pneumoniae and bordetella pertussis transmission in classrooms
Time frame: Within 14 days of case identification
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: Yes. Data elements will be made available by request with appropriate documentation and approvals.
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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.
Michelle Science principal investigator
The Hospital for Sick Children
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 SARS CoV 2 Infection and RSV Infection, run by The Hospital for Sick Children 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 9 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 1 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
To describe the viral dynamics of influenza, RSV and SARS-CoV-2 over time among children <18 years of age. (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 May 2026.