Covid19pSePNCT04904523
Blood Markers for Identifying & Investigating Infection With COVID19 & Sepsis in Children.
An observational study of Covid19 and Sepsis, run by Cardiff University at 1 site in United Kingdom.
Trial summary
Corona Virus Disease or COVID-19 is caused by SARS-CoV-2 virus. There have been reports of serious COVID-19 illness in children. In addition it has been linked to clusters of children presenting with high fevers and inflammation. Read more about this study
- Who is it for?
- Ages 1 day to 17 years
- What is being tested?
- Diagnostic Test:Blood test
- How many people
- 300 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Dec 2020to 30 Jun 2023
- 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 1 day to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Cases: 1. Children and young people up to age 18 years, admitted to PCCU with probable or confirmed COVID-19, irrespective of severity of illness. This includes patients transferred from other hospitals as well as those admitted from Accident and Emergency department. Controls: 1. Children proven to have a non COVID infectious illness on laboratory testing. 2. Children with sepsis or septic shock due to non-COVID infectious illness. 3. Children or young people admitted to PCCU following accidental trauma.
Who may be able to join
None listed.
Who cannot join
- Admitted to hospital for social reasons Or Declined consent by Parents or carers with legal responsibility or competent child Or Admitted to PCCU following a planned surgical procedure without an acute illness Or Direct clinical care team not able to provide research information in a language appropriate for non-English/Welsh speaking participants
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Cardiff University
Cardiff, CF 14 4XN
Peter Ghazal, PhD, 07977099046, GhazalP@Cardiff.ac.uk
About this study
Official title: Project Sepsis: Blood Markers Including Molecular and Cellular Profiling for Identifying and Investigating Severe CoronaVirus Disease 2019 and Sepsis in Children and Young People (pSEP/COVID-ChYP)
Corona Virus Disease or COVID-19 is caused by SARS-CoV-2 virus. There have been reports of serious COVID-19 illness in children. In addition it has been linked to clusters of children presenting with high fevers and inflammation.
Sepsis, also called blood poisoning, is an abnormal response of the body to some infections. We aim to conduct research in children under 18 admitted to intensive care unit.
Using a systems approach towards mapping the body's immune and metabolic responses to COVID-19 or related illnesses and compare with other sepsis like illnesses.
Read the detailed description
Corona Virus Disease or COVID-19 is caused by SARS-CoV-2 virus. There have been reports of serious COVID-19 illness in children. In addition it has been linked to clusters of children presenting with high fevers and inflammation.
Sepsis, also called blood poisoning, is an abnormal response of the body to some infections. We aim to conduct research in children under 18 admitted to intensive care unit and wards using blood samples. Blood samples as small as a quarter of a teaspoon, will be collected only alongside other routine blood tests. By analysing the blood samples, we aim to identify unique signals of information from the child or young person's genetic code as well as other chemical markers. This is to map the body's immune and metabolic response to COVID-19 or related illness and compare with other illnesses like sepsis. It will help us better understand COVID-19 illness and its association with the abnormal inflammatory response. The research will not delay emergency treatment for children or young people. Appropriate procedures for consent such as deferred consent will be used in children or young people with serious illness. Young people of 16 and 17 years of age will be assessed for capacity to consent. The study results will not influence the clinical care of patients. The research would not be identifying any other genetic disorders. Even though the data obtained includes some unique genetic information, the research only uses anonymised details from patients and there is no risk to confidentiality. Remaining blood following analysis will be stored in Biobank for an agreed duration. Specific consent will be obtained from parents or legal guardians, or young people with capacity for analysis and collection of unique genetic data, clinical information, sample storage and use of anonymous but unique genetic data for other research.
- Being tested
- Diagnostic Test:Blood test
- Medical subject headings
- COVID-19, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic Test:Blood testDiagnostic test
Drop of blood for RNA and metabolic analysis
| Study group | Role | What they receive |
|---|---|---|
| Cases | Cases:
1. Children and young people up to age 18 years, admitted to PCCU with probable or confirmed COVID-19, irrespective of severity of illness. This includes patients transferred from other hospitals as well as those admitted from Accident and Emergency department. Receives: Diagnostic Test: Diagnostic Test:Blood test | |
| Controls | Controls:
1. Children proven to have a non COVID infectious illness on laboratory testing.
2. Children with sepsis or septic shock due to non-COVID infectious illness.
3. Children or young people admitted to PCCU following accidental trauma. Receives: Diagnostic Test: Diagnostic Test:Blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Outcome 1
To evaluate known blood molecular and genomic markers of infection in children and young persons with confirmed or probable COVID19 and compare with non COVID19 illnesses.
Measured: 3 years
Secondary outcomes (1)
Outcome 2
To investigate systemic pathway biology of SARS-CoV-2 infection and by comparison with other viral and bacterial sepsis cases identify new signatures associated with COVID-19 in patients up to 18 years of age.
To profile molecular analytes (proteins, lipids and nucleic acids) and blood cell phenotypes in children with sepsis
Measured: 3 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2021
- Study start16 Dec 2020
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
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 Covid19Studies of the same condition, open and under way.
- 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cardiff University
- Sponsor type
- University, hospital or other
- Collaborators
- Cardiff and Vale University Health Board
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04904523
- Sponsor's protocol ID
- pSEP-COVID ChYP 263530
- Acronym
- pSeP
- Status last verified
- May 2021
- First submitted
- 26 May 2021
- Last updated
- 27 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Oruganti S, Rodrigues PRS, White D, Watkins WJ, Shapey S, Barrow A, Al Samsam R, Ali S, Gajraj M, Skone R, Jardine M, Evans J, Struik S, Song JE, Abood L, Paquete B, Foulkes S, Saunders B, Strang A, Kotecha SJ, Phillips B, Evans A, Buchanan I, Bowes S, Ali B, Gore M, Thomas-Turner R, Andrews R, Zaher S, Sharma S, Chakraborty M, Parkinson E, Liberatore F, Woolley T, Edkins S, Davies LC, Moet L, McLaren JE, Watson GL, O'Donnell V, Hood K, Ghazal P. Immune and metabolic markers for identifying and investigating severe Coronavirus disease and Sepsis in children and young people (pSeP/COVID ChYP study): protocol for a prospective cohort study. BMJ Open. 2023 Mar 27;13(3):e067002. doi: 10.1136/bmjopen-2022-067002.
PubMed 36972964
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project Sepsis: Blood Markers Including Molecular and Cellular Profiling for Identifying and Investigating Severe CoronaVirus Disease 2019 and Sepsis in Children and Young People (pSEP/COVID-ChYP)
- ClinicalTrials.gov ID
- NCT04904523
- Acronym / sponsor ID
- pSeP / pSEP-COVID ChYP 263530
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Cardiff UniversityUniversity, hospital or other
- Collaborators
- Cardiff and Vale University Health Board
- Study start
- 16 Dec 2020 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 27 May 2021 (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.
Corona Virus Disease or COVID-19 is caused by SARS-CoV-2 virus. There have been reports of serious COVID-19 illness in children. In addition it has been linked to clusters of children presenting with high fevers and inflammation.
Sepsis, also called blood poisoning, is an abnormal response of the body to some infections. We aim to conduct research in children under 18 admitted to intensive care unit.
Using a systems approach towards mapping the body's immune and metabolic responses to COVID-19 or related illnesses and compare with other sepsis like illnesses.
Detailed description
Corona Virus Disease or COVID-19 is caused by SARS-CoV-2 virus. There have been reports of serious COVID-19 illness in children. In addition it has been linked to clusters of children presenting with high fevers and inflammation.
Sepsis, also called blood poisoning, is an abnormal response of the body to some infections. We aim to conduct research in children under 18 admitted to intensive care unit and wards using blood samples. Blood samples as small as a quarter of a teaspoon, will be collected only alongside other routine blood tests. By analysing the blood samples, we aim to identify unique signals of information from the child or young person's genetic code as well as other chemical markers. This is to map the body's immune and metabolic response to COVID-19 or related illness and compare with other illnesses like sepsis. It will help us better understand COVID-19 illness and its association with the abnormal inflammatory response. The research will not delay emergency treatment for children or young people. Appropriate procedures for consent such as deferred consent will be used in children or young people with serious illness. Young people of 16 and 17 years of age will be assessed for capacity to consent. The study results will not influence the clinical care of patients. The research would not be identifying any other genetic disorders. Even though the data obtained includes some unique genetic information, the research only uses anonymised details from patients and there is no risk to confidentiality. Remaining blood following analysis will be stored in Biobank for an agreed duration. Specific consent will be obtained from parents or legal guardians, or young people with capacity for analysis and collection of unique genetic data, clinical information, sample storage and use of anonymous but unique genetic data for other research.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Diagnostic Test: Diagnostic Test:Blood testCases: 1. Children and young people up to age 18 years, admitted to PCCU with probable or confirmed COVID-19, irrespective of severity of illness. This includes patients transferred from other hospitals as well as those admitted from Accident and Emergency department. |
| Controls | – | Diagnostic Test: Diagnostic Test:Blood testControls: 1. Children proven to have a non COVID infectious illness on laboratory testing. 2. Children with sepsis or septic shock due to non-COVID infectious illness. 3. Children or young people admitted to PCCU following accidental trauma. |
Who may qualify
- Ages
- 1 day to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Cases: 1. Children and young people up to age 18 years, admitted to PCCU with probable or confirmed COVID-19, irrespective of severity of illness. This includes patients transferred from other hospitals as well as those admitted from Accident and Emergency department. Controls: 1. Children proven to have a non COVID infectious illness on laboratory testing. 2. Children with sepsis or septic shock due to non-COVID infectious illness. 3. Children or young people admitted to PCCU following accidental trauma.
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Admitted to hospital for social reasons Or Declined consent by Parents or carers with legal responsibility or competent child Or Admitted to PCCU following a planned surgical procedure without an acute illness Or Direct clinical care team not able to provide research information in a language appropriate for non-English/Welsh speaking participants
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 |
|---|---|---|
| Diagnostic Test:Blood testDrop of blood for RNA and metabolic analysis | Diagnostic test | Cases, Controls |
Primary outcome
Outcome 1
Time frame: 3 years
To evaluate known blood molecular and genomic markers of infection in children and young persons with confirmed or probable COVID19 and compare with non COVID19 illnesses.
1 secondary outcome
Outcome 2
Time frame: 3 Years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2021.
- Derived from this study: PubMed 36972964Oruganti S, Rodrigues PRS, White D, Watkins WJ, Shapey S, Barrow A, Al Samsam R, Ali S, Gajraj M, Skone R, Jardine M, Evans J, Struik S, Song JE, Abood L, Paquete B, Foulkes S, Saunders B, Strang A, Kotecha SJ, Phillips B, Evans A, Buchanan I, Bowes S, Ali B, Gore M, Thomas-Turner R, Andrews R, Zaher S, Sharma S, Chakraborty M, Parkinson E, Liberatore F, Woolley T, Edkins S, Davies LC, Moet L, McLaren JE, Watson GL, O'Donnell V, Hood K, Ghazal P. Immune and metabolic markers for identifying and investigating severe Coronavirus disease and Sepsis in children and young people (pSeP/COVID ChYP study): protocol for a prospective cohort study. BMJ Open. 2023 Mar 27;13(3):e067002. doi: 10.1136/bmjopen-2022-067002.
- Individual participant dataSharing planned: Undecided
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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.
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 Covid19 and Sepsis, run by Cardiff University at 1 site in United Kingdom.
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 0 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: status not confirmed, as of the sponsor's last update on 27 May 2021. 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 United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peter Ghazal, PhD (07977099046, GhazalP@Cardiff.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Outcome 1 (time frame: 3 years). 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 NCT04904523, 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 27 May 2021.