SARS-CoV2 Infection, COVID-19NCT05240183
Viral Dynamics of Omicron in Children
An observational study of SARS-CoV2 Infection, COVID-19, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
SARS-CoV-2 transmission is dependent on multiple factors, which may be related to either host-virus interaction or the environment. While there have been several studies evaluation viral dynamics and transmission risk in adults, there is limited pediatric data available. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- SARS-CoV2 Infection, COVID-19
- What is being tested?
- Daily SARS-CoV-2 PCR Testing for 10 days
- How many people
- 107 participants
- Where
- 1 siteCanada
- Study dates
- 4 Feb 2022to 31 Aug 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 Up to 18 years
- All sexes
- Child, Adult
Study population: All children less than 19 years of age with acute SARS-CoV-2 infection
To be included in the study, the participant must be:
- Less than 19 years of age
- Have a positive molecular or rapid antigen test in the previous 48 hours
- If symptomatic, onset of any COVID-19 symptom within last 72 hours.
- If asymptomatic, evidence to support acute infection (e.g. negative PCR in the last 5 days, known household exposure where index case is clear)
- Able to collect daily samples
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Viral Dynamics of the SARS-CoV-2 Omicron Variant in Paediatric Patients
SARS-CoV-2 transmission is dependent on multiple factors, which may be related to either host-virus interaction or the environment. While there have been several studies evaluation viral dynamics and transmission risk in adults, there is limited pediatric data available. The objective of this study is to characterize the period of communicability for children less than 19 years of age with SARS-CoV-2 infection with the Omicron variant.
Read the detailed description
The goal of our study is to assess the viral dynamics of SARS-CoV-2 infection in children < 19 years with acute infection to inform public health practice.
Specific Aims:
- Describe the kinetics of SARS-CoV-2 viral load in children with acute SARS-CoV-2 infection
- Assess the impact of various host factors on viral dynamics, including age (<1 year, 1-4 years, 5-11 years, 12-18 years), symptoms, clinical severity (hospitalization vs. outpatient), comorbidities (immunocompromised vs. not immunocompromised), vaccination (none, 1 dose, 2 doses)
- Estimate the time point at which children are less likely to be infectious
- Assess the sensitivity of self-collected rapid antigen testing (RAT) in children, compared to PCR (e.g. assess RAT test performance in children)
- Conditions
- SARS-CoV2 Infection, COVID-19
- Being tested
- Daily SARS-CoV-2 PCR Testing for 10 days
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily SARS-CoV-2 PCR Testing for 10 daysDiagnostic test
Each participant will undergo daily SARS-CoV-2 PCR testing to assess viral dynamics
What is being measured
The primary outcome is the main question the study is designed to answer.
SARS-CoV-2 Viral Load
We will use prospective longitudinal quantitative reverse transcription PCR testing to measure the viral RNA trajectories for individuals in the study.
Measured: 10 days
Secondary outcomes (1)
Rapid antigen test sensitivity
We will describe the RAT positivity on Days 1 to 10 and evaluate the performance of RAT compared to PCR
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2022
- Study start4 Feb 2022
- Primary completion31 Mar 2022
- Study completion31 Aug 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 SARS-CoV2 Infection, COVID-19Studies 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
- 107 participants (actual)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05240183
- Sponsor's protocol ID
- 1000079263
- Status last verified
- Nov 2022
- First submitted
- 4 Feb 2022
- Last updated
- 28 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Science M, Orkin J, Maguire B, Bitnun A, Bourns L, Corbeil A, Johnstone J, Macdonald L, Schwartz KL, Bruce Barrett C, Reinprecht J, Heisey A, Nasso S, Juni P, Campigotto A. Viral Dynamics of the SARS-CoV-2 Omicron Variant in Pediatric Patients: A Prospective Cohort Study. Clin Infect Dis. 2024 Jun 14;78(6):1506-1513. doi: 10.1093/cid/ciad740.
PubMed 38084906
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Viral Dynamics of the SARS-CoV-2 Omicron Variant in Paediatric Patients
- ClinicalTrials.gov ID
- NCT05240183
- Acronym / sponsor ID
- 1000079263
- Conditions
- SARS-CoV2 Infection, COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- 4 Feb 2022 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 15 Feb 2022 (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.
SARS-CoV-2 transmission is dependent on multiple factors, which may be related to either host-virus interaction or the environment. While there have been several studies evaluation viral dynamics and transmission risk in adults, there is limited pediatric data available. The objective of this study is to characterize the period of communicability for children less than 19 years of age with SARS-CoV-2 infection with the Omicron variant.
Detailed description
The goal of our study is to assess the viral dynamics of SARS-CoV-2 infection in children < 19 years with acute infection to inform public health practice.
Specific Aims:
- Describe the kinetics of SARS-CoV-2 viral load in children with acute SARS-CoV-2 infection
- Assess the impact of various host factors on viral dynamics, including age (<1 year, 1-4 years, 5-11 years, 12-18 years), symptoms, clinical severity (hospitalization vs. outpatient), comorbidities (immunocompromised vs. not immunocompromised), vaccination (none, 1 dose, 2 doses)
- Estimate the time point at which children are less likely to be infectious
- Assess the sensitivity of self-collected rapid antigen testing (RAT) in children, compared to PCR (e.g. assess RAT test performance in children)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- All children less than 19 years of age with acute SARS-CoV-2 infection
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 SARS-CoV-2 PCR Testing for 10 daysEach participant will undergo daily SARS-CoV-2 PCR testing to assess viral dynamics | Diagnostic test | – |
Primary outcome
SARS-CoV-2 Viral Load
Time frame: 10 days
We will use prospective longitudinal quantitative reverse transcription PCR testing to measure the viral RNA trajectories for individuals in the study.
1 secondary outcome
Rapid antigen test sensitivity
Time frame: 10 days
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 28 Nov 2022.
- Derived from this study: PubMed 38084906Science M, Orkin J, Maguire B, Bitnun A, Bourns L, Corbeil A, Johnstone J, Macdonald L, Schwartz KL, Bruce Barrett C, Reinprecht J, Heisey A, Nasso S, Juni P, Campigotto A. Viral Dynamics of the SARS-CoV-2 Omicron Variant in Pediatric Patients: A Prospective Cohort Study. Clin Infect Dis. 2024 Jun 14;78(6):1506-1513. doi: 10.1093/cid/ciad740.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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-CoV2 Infection, COVID-19, 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?
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 28 Nov 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?
SARS-CoV-2 Viral Load (time frame: 10 days). 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 NCT05240183, 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 28 Nov 2022.