Paediatric Inflammatory Multisystem Syndrome Temporally Associated With SARS-Cov-2NCT04761913
Paediatric Inflammatory Multisystem Syndrome During COVID-19 Pandemic
An observational study of Paediatric Inflammatory Multisystem Syndrome Temporally Associated With SARS-Cov-2, run by Anglia Ruskin University at 6 sites in United Kingdom.
Trial summary
During the COVID-19 pandemic, a small minority of children have been presenting to acute paediatric services with a new syndrome, Paediatric Inflammatory Multisystem Syndrome temporally associated with SARS-Cov-2 (PIMS-TS). Read more about this study
- Who is it for?
- Ages 3 months to 16 years
- Conditions the study is for
- Paediatric Inflammatory Multisystem Syndrome Temporally Associated With SARS-Cov-2
- How many people
- 40 participants
- Where
- 6 sitesUnited Kingdom
- Study dates
- 22 Jun 2021to 31 Dec 2021
- 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 3 months to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Children (aged 3 months to ≤ 16 years) presenting to acute paediatric services (non-ICU) with symptoms of PIMS during the period of the COVID-19 pandemic
Who may be able to join
- Within the age range of 3 months to ≤16 years
- Presenting clinically to non-ICU paediatric acute services at hospitals in the East of England region with symptoms suggestive of PIMS (e.g. incomplete Kawasaki's disease/Toxic Shock Syndrome) i.e. having: persistent fever (>38.0oC for 5 or more days) AND high CRP (>80) AND with one or more of additional features listed in Appendix 1 of the RCPCH document 'Guidance: paediatric multisystem inflammatory syndrome temporarily associated with COVID-19'
- Having either a positive or negative SARS-Cov-2 PCR test
Who cannot join
- Aged below 3 months old or above 16 years old
- Confirmation of any microbial cause other than SARS-Cov-2 (including bacterial sepsis, staphylococcal or streptococcal shock syndromes, infections associated with myocarditis such as enterovirus). Determination of such microbial causes is by routine testing i.e. blood culture; pneumococcal, meningococcal, group A strep, staph aureus blood PCR; ASOT; EBV, CMV, adenovirus, enterovirus PCR on blood; urine and stool culture; throat swab culture; stool virology.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United Kingdom6 sites
Mid Essex Hospital Trust
Chelmsford, Essex, CM1 7ET
East Suffolk and north Essex NHS Foundation Trust
Colchester, Essex, CO4 5JL
James Paget University Hospitals NHS Foundation Trust
Great Yarmouth, Norfolk, NR31 6LA
The Princess Alexandra Hospital NHS Trust
Harlow, Essex, CM20 1QX
East Suffolk and North Essex Foundation Trust
Ipswich, Suffolk, IP4 5PD
Norfolk and Norwich University Hospitals NHS Foundation Trust
Norwich, Norfolk, NR4 7UY
About this study
Official title: Investigating Cytokine Storm Biomarkers in Children Presenting to Acute Paediatric Services (Non-intensive Care) With Paediatric Inflammatory Multisystem Syndrome During the Covid-19 Pandemic. An Observation Study
During the COVID-19 pandemic, a small minority of children have been presenting to acute paediatric services with a new syndrome, Paediatric Inflammatory Multisystem Syndrome temporally associated with SARS-Cov-2 (PIMS-TS). Children with PIMS-TS present with symptoms of inflammation caused by the immune system going into overdrive - this is likely to be in response to the virus. More severe cases involve inflammation and damage to the heart.
The focus of this project is to identify children with milder forms of PIMS-TS who are at risk of progression to more severe disease. Being able to predict the disease course of PIMS-TS at an early stage is important as it will allow clinicians to decide which patients should be treated with immunosuppressants, which have been shown to reduce the severity of the illness but have side effects.
Early data suggests that children with PIMS-TS have elevated biomarkers associated with an over-reaction of the body's immune system (also known as a 'cytokine storm') reaction. This study will explore whether children presenting with milder PIMS-TS have elevated 'cytokine storm' blood profiles and whether these profiles differ between children who continue to have a mild disease course compared to those who develop severe disease.
Read the detailed description
During the COVID-19 pandemic a minority of children have presented to acute services with clinical features of a new syndrome known as Paediatric Inflammatory Multisystem Syndrome temporally associated with SARS-Cov-2 (PIMS-TS). This high inflammatory state, likely triggered by the virus, has overlapping features of Kawasaki's and Toxic Shock Syndrome.
The focus of this study is to identify which children presenting with mild PIMS-TS symptoms will go on to develop severe disease requiring intensive care unit (ICU) admission. This is important as data suggests that early aggressive treatment with immunosuppression can lead to a relatively quick resolution in symptoms. The results of this study could allow clinicians to be selective in treating patients in whom the benefits of treatment outweigh the risks.
Early data suggests a 'cytokine storm' is involved in the PIMS-TS disease process. This proposed observational study will investigate whether children presenting to the non-ICU setting with features of PIMS-TS have raised cytokine storm biomarkers and whether these may be used to predict which children go onto develop severe disease.
The proposed study will include up to 15 hospitals across East of England. NHS clinical care teams will identify patients meeting the inclusion criteria and upload anonymised data into a secure web-based study database. Data will be retrieved for retrospective cases from 1st March 2020 and prospective data entered up until September 2021.
One hundred children presenting to acute (non-ICU) paediatric services with symptoms of PIMS-TS during the study period will be included.
The primary objective of the study is to describe the 'cytokine storm' biomarker profiles of children aged between 3 months to 16 years presenting with PIMS-TS to the non-ICU setting, focussing on those biomarkers which are readily accessible to district general hospitals (Pro-Beta Natriuretic peptide [BNP], ferritin, and CRP).
The secondary aims of the study are to:
- Compare cytokine storm biomarker profiles of children who have a mild disease course to those who develop severe disease to identify whether there are any differences between these groups
- Evaluate the association between cytokine storm biomarker profiles and severe events
- Compare i) demographic characteristics (including pre-existing disease), and ii) other routine clinical investigations of children who have a mild disease course and those who develop severe disease to identify any differences between these 2 groups
- Evaluate the association between vaccination status and disease severity
- Compare cytokine storm biomarker profiles of children testing positive and those testing negative for SARS-CoV-2 via PCR on 2x nasopharyngeal swabs to identify any differences between these 2 groups.
- Keywords
- cytokine storm, biomarkers, PIMS-TS, children, COVID-19
- Medical subject headings
- Cytokine Release Syndrome, pediatric multisystem inflammatory disease, COVID-19 related, COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood biomarker associated with a cytokine storm - Pro-Beta Natriuretic Peptide (measured in pg/mL).
Pro-Beta Natriuretic Peptide (BNP) measured as part of routine clinical care. NHS care teams will upload anonymised routine clinical measurements into a secure study database.
Measured: From date of admission to date of discharge from hospital assessed up to 18 months
Blood biomarker associated with a cytokine storm - Ferritin (measured in µg/L)
Ferritin measured as part of routine clinical care. NHS care teams will upload anonymised routine clinical measurements into a secure study database.
Measured: From date of admission to date of discharge from hospital assessed up to 18 months
Blood Biomarker associated with a cytokine storm - C-Reactive Protein (measured in mg/L)
C-Reactive Protein measured as part of routine clinical care. NHS care teams will upload anonymised routine clinical measurements into a secure study database.
Measured: From date of admission to date of discharge from hospital assessed up to 18 months
Secondary outcomes (33)
Demographic characteristics including age, sex, ethnicity and pre-existing morbidities
Information collected as part of routine clinical care. NHS clinical care teams will upload anonymous data into a secure study database.
Measured: At admission to hospital
Hospital stay data
Information collected as part of routine clinical care. NHS clinical care teams will upload anonymous data into a secure study database.
Measured: From date of admission to date of discharge from hospital assessed up to 18 months
Cytokine storm biomarker measured in mg/L (CRP)
Clinical investigations (blood biomarkers) collected as part of routine clinical care
Measured: From date of admission to date of discharge from hospital assessed up to 18 months
Cytokine storm biomarkers measured in pg/mL (pro-beta natriuretic peptide, IL-6, IFN-gamma, IL-10, TNF-alpha)
Clinical investigations (blood biomarkers) collected as part of routine clinical care
Measured: From date of admission to date of discharge from hospital assessed up to 18 months
Full blood count measures in 10^9/L (white cell count - neutrophil and lymphocyte count and platelet)
Clinical investigations (blood biomarkers) collected as part of routine clinical care
Measured: From date of admission to date of discharge from hospital assessed up to 18 months
Full blood count measures in L/L (haematocrit)
Clinical investigations (blood biomarkers) collected as part of routine clinical care
Measured: From date of admission to date of discharge from hospital assessed up to 18 months
Haemoglobin in g/L or g/dL (measured as part of full blood count and blood gas analysis)
Clinical investigations (blood biomarkers) collected as part of routine clinical care
Measured: From date of admission to date of discharge from hospital assessed up to 18 months
Blood gas analysis measured in KPa (pCO2, pO2)
Clinical investigations (blood biomarkers) collected as part of routine clinical care
Measured: From date of admission to date of discharge from hospital assessed up to 18 months
Blood gas analysis measured in mmol/l (glucose, lactate, Na, K and Cl)
Clinical investigations (blood biomarkers) collected as part of routine clinical care
Measured: From date of admission to date of discharge from hospital assessed up to 18 months
Blood gas analysis measured in mmol/l or mEq/L (HCO3, BE)
Clinical investigations (blood biomarkers) collected as part of routine clinical care
Measured: From date of admission to date of discharge from hospital assessed up to 18 months
Liver function tests measured in g/L (protein, albumin, globulin)
Clinical investigations (blood biomarkers) collected as part of routine clinical care
Measured: From date of admission to date of discharge from hospital assessed up to 18 months
Liver function tests measured in U/L (ALP/ALT)
Clinical investigations (blood biomarkers) collected as part of routine clinical care
Measured: From date of admission to date of discharge from hospital assessed up to 18 months
Liver function tests measured in µmol/L (bilirubin)
Clinical investigations (blood biomarkers) collected as part of routine clinical care
Measured: From date of admission to date of discharge from hospital assessed up to 18 months
Troponin measured in ng/ml or ng/L
Clinical investigations (blood biomarkers) collected as part of routine clinical care
Measured: From date of admission to date of discharge from hospital assessed up to 18 months
vitamin D measured in nmol/L
Clinical investigations (blood biomarkers) collected as part of routine clinical care
Measured: From date of admission to date of discharge from hospital assessed up to 18 months
Amylase, CK, LDH measured in U/L
Clinical investigations (blood biomarkers) collected as part of routine clinical care
Measured: From date of admission to date of discharge from hospital assessed up to 18 months
Glucose and triglycerides measured in mmol/L
Clinical investigations (blood biomarkers) collected as part of routine clinical care
Measured: From date of admission to date of discharge from hospital assessed up to 18 months
Urea and electrolytes measured in mmol/L (Na, K, urea)
Clinical investigations (blood biomarkers) collected as part of routine clinical care
Measured: From date of admission to date of discharge from hospital assessed up to 18 months
Urea and electrolytes measured in µmol/L (creatinine)
Clinical investigations (blood biomarkers) collected as part of routine clinical care
Measured: From date of admission to date of discharge from hospital assessed up to 18 months
ferritin measured in µg/L
Clinical investigations (blood biomarkers) collected as part of routine clinical care
Measured: From date of admission to date of discharge from hospital assessed up to 18 months
fibrinogen measured in g/L
Clinical investigations (blood biomarkers) collected as part of routine clinical care
Measured: From date of admission to date of discharge from hospital assessed up to 18 months
D-dimer measured in ng/ml
Clinical investigations (blood biomarkers) collected as part of routine clinical care
Measured: From date of admission to date of discharge from hospital assessed up to 18 months
PT and APTT measured in seconds
Clinical investigations (blood biomarkers) collected as part of routine clinical care
Measured: From date of admission to date of discharge from hospital assessed up to 18 months
INR as a ratio (Patient PT/Control PT)
Clinical investigations (blood biomarkers) collected as part of routine clinical care
Measured: From date of admission to date of discharge from hospital assessed up to 18 months
Acute Kidney Injury graded as no AKI or stage of AKI (1-3)
Clinical investigations (blood biomarkers) collected as part of routine clinical care
Measured: From date of admission to date of discharge from hospital assessed up to 18 months
Positive or negative COVID-19 antibody test
Clinical investigations (blood biomarkers) collected as part of routine clinical care
Measured: From date of admission to date of discharge from hospital assessed up to 18 months
Presence or absence of clinical conditions as assessed by ECG/echocardiography
Conditions will include: myocarditis, valvulitis, pericardial effusion, coronary artery dilation, or other conditions.
Measured: From date of admission to date of discharge from hospital assessed up to 18 months
Presence or absence of clinical conditions as assessed by chest x-ray/chest CT
Conditions will include: presence of patchy symmetrical infiltrates, pleural effusion, coronary artery abnormalities (CT with contrast) or other conditions.
Measured: From date of admission to date of discharge from hospital assessed up to 18 months
Presence or absence of clinical conditions as assessed by abdominal ultrasound
Conditions will include: colitis, ileitis, lymphadenopathy, ascites, hepatosplenomegaly or other conditions.
Measured: From date of admission to date of discharge from hospital assessed up to 18 months
Proteinuria as assessed by urinalysis graded as no protein, protein ++ or protein +++
Measured: From date of admission to date of discharge from hospital assessed up to 18 months
Positive or negative COVID swab result as assessed by PCR
Measured: From date of admission to date of discharge from hospital assessed up to 18 months
Positive or negative NPA or throat swab result for respiratory panel as assessed by PCR
Including: pneumococcal, meningococcal, Group A Strep, Staph Aureus, EBV, CMV, Andenovirus, Enterovirus
Measured: From date of admission to date of discharge from hospital assessed up to 18 months
Vaccination status
Information collected as part of routine clinical care. NHS clinical care teams will upload anonymous data into a secure study database.
Measured: At admission to hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start22 Jun 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paediatric Inflammatory Multisystem Syndrome Temporally Associated With SARS-Cov-2Studies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anglia Ruskin University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jo-Anne Johnson, MRCPCH, PhD, Principal investigator, Anglia Ruskin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04761913
- Sponsor's protocol ID
- 19/20/048
- Status last verified
- Oct 2021
- First submitted
- 11 Dec 2020
- Last updated
- 9 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Cytokine Storm Biomarkers in Children Presenting to Acute Paediatric Services (Non-intensive Care) With Paediatric Inflammatory Multisystem Syndrome During the Covid-19 Pandemic. An Observation Study
- ClinicalTrials.gov ID
- NCT04761913
- Acronym / sponsor ID
- 19/20/048
- Keywords
- cytokine storm, biomarkers, PIMS-TS, children, COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Anglia Ruskin UniversityUniversity, hospital or other
- Study start
- 22 Jun 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 21 Feb 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.
During the COVID-19 pandemic, a small minority of children have been presenting to acute paediatric services with a new syndrome, Paediatric Inflammatory Multisystem Syndrome temporally associated with SARS-Cov-2 (PIMS-TS). Children with PIMS-TS present with symptoms of inflammation caused by the immune system going into overdrive - this is likely to be in response to the virus. More severe cases involve inflammation and damage to the heart.
The focus of this project is to identify children with milder forms of PIMS-TS who are at risk of progression to more severe disease. Being able to predict the disease course of PIMS-TS at an early stage is important as it will allow clinicians to decide which patients should be treated with immunosuppressants, which have been shown to reduce the severity of the illness but have side effects.
Early data suggests that children with PIMS-TS have elevated biomarkers associated with an over-reaction of the body's immune system (also known as a 'cytokine storm') reaction. This study will explore whether children presenting with milder PIMS-TS have elevated 'cytokine storm' blood profiles and whether these profiles differ between children who continue to have a mild disease course compared to those who develop severe disease.
Detailed description
During the COVID-19 pandemic a minority of children have presented to acute services with clinical features of a new syndrome known as Paediatric Inflammatory Multisystem Syndrome temporally associated with SARS-Cov-2 (PIMS-TS). This high inflammatory state, likely triggered by the virus, has overlapping features of Kawasaki's and Toxic Shock Syndrome.
The focus of this study is to identify which children presenting with mild PIMS-TS symptoms will go on to develop severe disease requiring intensive care unit (ICU) admission. This is important as data suggests that early aggressive treatment with immunosuppression can lead to a relatively quick resolution in symptoms. The results of this study could allow clinicians to be selective in treating patients in whom the benefits of treatment outweigh the risks.
Early data suggests a 'cytokine storm' is involved in the PIMS-TS disease process. This proposed observational study will investigate whether children presenting to the non-ICU setting with features of PIMS-TS have raised cytokine storm biomarkers and whether these may be used to predict which children go onto develop severe disease.
The proposed study will include up to 15 hospitals across East of England. NHS clinical care teams will identify patients meeting the inclusion criteria and upload anonymised data into a secure web-based study database. Data will be retrieved for retrospective cases from 1st March 2020 and prospective data entered up until September 2021.
One hundred children presenting to acute (non-ICU) paediatric services with symptoms of PIMS-TS during the study period will be included.
The primary objective of the study is to describe the 'cytokine storm' biomarker profiles of children aged between 3 months to 16 years presenting with PIMS-TS to the non-ICU setting, focussing on those biomarkers which are readily accessible to district general hospitals (Pro-Beta Natriuretic peptide [BNP], ferritin, and CRP).
The secondary aims of the study are to:
- Compare cytokine storm biomarker profiles of children who have a mild disease course to those who develop severe disease to identify whether there are any differences between these groups
- Evaluate the association between cytokine storm biomarker profiles and severe events
- Compare i) demographic characteristics (including pre-existing disease), and ii) other routine clinical investigations of children who have a mild disease course and those who develop severe disease to identify any differences between these 2 groups
- Evaluate the association between vaccination status and disease severity
- Compare cytokine storm biomarker profiles of children testing positive and those testing negative for SARS-CoV-2 via PCR on 2x nasopharyngeal swabs to identify any differences between these 2 groups.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 3 months to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children (aged 3 months to ≤ 16 years) presenting to acute paediatric services (non-ICU) with symptoms of PIMS during the period of the COVID-19 pandemic
Key inclusion criteria (3 listed)
- Within the age range of 3 months to ≤16 years
- Presenting clinically to non-ICU paediatric acute services at hospitals in the East of England region with symptoms suggestive of PIMS (e.g. incomplete Kawasaki's disease/Toxic Shock Syndrome) i.e. having: persistent fever (>38.0oC for 5 or more days) AND high CRP (>80) AND with one or more of additional features listed in Appendix 1 of the RCPCH document 'Guidance: paediatric multisystem inflammatory syndrome temporarily associated with COVID-19'
- Having either a positive or negative SARS-Cov-2 PCR test
Key exclusion criteria (2 listed)
- Aged below 3 months old or above 16 years old
- Confirmation of any microbial cause other than SARS-Cov-2 (including bacterial sepsis, staphylococcal or streptococcal shock syndromes, infections associated with myocarditis such as enterovirus). Determination of such microbial causes is by routine testing i.e. blood culture; pneumococcal, meningococcal, group A strep, staph aureus blood PCR; ASOT; EBV, CMV, adenovirus, enterovirus PCR on blood; urine and stool culture; throat swab culture; stool virology.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Blood biomarker associated with a cytokine storm - Pro-Beta Natriuretic Peptide (measured in pg/mL).
Time frame: From date of admission to date of discharge from hospital assessed up to 18 months
Pro-Beta Natriuretic Peptide (BNP) measured as part of routine clinical care. NHS care teams will upload anonymised routine clinical measurements into a secure study database.
Blood biomarker associated with a cytokine storm - Ferritin (measured in µg/L)
Time frame: From date of admission to date of discharge from hospital assessed up to 18 months
Ferritin measured as part of routine clinical care. NHS care teams will upload anonymised routine clinical measurements into a secure study database.
Blood Biomarker associated with a cytokine storm - C-Reactive Protein (measured in mg/L)
Time frame: From date of admission to date of discharge from hospital assessed up to 18 months
C-Reactive Protein measured as part of routine clinical care. NHS care teams will upload anonymised routine clinical measurements into a secure study database.
33 secondary outcomes
Demographic characteristics including age, sex, ethnicity and pre-existing morbidities
Time frame: At admission to hospital
Hospital stay data
Time frame: From date of admission to date of discharge from hospital assessed up to 18 months
Cytokine storm biomarker measured in mg/L (CRP)
Time frame: From date of admission to date of discharge from hospital assessed up to 18 months
Cytokine storm biomarkers measured in pg/mL (pro-beta natriuretic peptide, IL-6, IFN-gamma, IL-10, TNF-alpha)
Time frame: From date of admission to date of discharge from hospital assessed up to 18 months
Full blood count measures in 10^9/L (white cell count - neutrophil and lymphocyte count and platelet)
Time frame: From date of admission to date of discharge from hospital assessed up to 18 months
Full blood count measures in L/L (haematocrit)
Time frame: From date of admission to date of discharge from hospital assessed up to 18 months
Haemoglobin in g/L or g/dL (measured as part of full blood count and blood gas analysis)
Time frame: From date of admission to date of discharge from hospital assessed up to 18 months
Blood gas analysis measured in KPa (pCO2, pO2)
Time frame: From date of admission to date of discharge from hospital assessed up to 18 months
Blood gas analysis measured in mmol/l (glucose, lactate, Na, K and Cl)
Time frame: From date of admission to date of discharge from hospital assessed up to 18 months
Blood gas analysis measured in mmol/l or mEq/L (HCO3, BE)
Time frame: From date of admission to date of discharge from hospital assessed up to 18 months
Liver function tests measured in g/L (protein, albumin, globulin)
Time frame: From date of admission to date of discharge from hospital assessed up to 18 months
Liver function tests measured in U/L (ALP/ALT)
Time frame: From date of admission to date of discharge from hospital assessed up to 18 months
Liver function tests measured in µmol/L (bilirubin)
Time frame: From date of admission to date of discharge from hospital assessed up to 18 months
Troponin measured in ng/ml or ng/L
Time frame: From date of admission to date of discharge from hospital assessed up to 18 months
vitamin D measured in nmol/L
Time frame: From date of admission to date of discharge from hospital assessed up to 18 months
Amylase, CK, LDH measured in U/L
Time frame: From date of admission to date of discharge from hospital assessed up to 18 months
Glucose and triglycerides measured in mmol/L
Time frame: From date of admission to date of discharge from hospital assessed up to 18 months
Urea and electrolytes measured in mmol/L (Na, K, urea)
Time frame: From date of admission to date of discharge from hospital assessed up to 18 months
Urea and electrolytes measured in µmol/L (creatinine)
Time frame: From date of admission to date of discharge from hospital assessed up to 18 months
ferritin measured in µg/L
Time frame: From date of admission to date of discharge from hospital assessed up to 18 months
fibrinogen measured in g/L
Time frame: From date of admission to date of discharge from hospital assessed up to 18 months
D-dimer measured in ng/ml
Time frame: From date of admission to date of discharge from hospital assessed up to 18 months
PT and APTT measured in seconds
Time frame: From date of admission to date of discharge from hospital assessed up to 18 months
INR as a ratio (Patient PT/Control PT)
Time frame: From date of admission to date of discharge from hospital assessed up to 18 months
Acute Kidney Injury graded as no AKI or stage of AKI (1-3)
Time frame: From date of admission to date of discharge from hospital assessed up to 18 months
Positive or negative COVID-19 antibody test
Time frame: From date of admission to date of discharge from hospital assessed up to 18 months
Presence or absence of clinical conditions as assessed by ECG/echocardiography
Time frame: From date of admission to date of discharge from hospital assessed up to 18 months
Presence or absence of clinical conditions as assessed by chest x-ray/chest CT
Time frame: From date of admission to date of discharge from hospital assessed up to 18 months
Presence or absence of clinical conditions as assessed by abdominal ultrasound
Time frame: From date of admission to date of discharge from hospital assessed up to 18 months
Proteinuria as assessed by urinalysis graded as no protein, protein ++ or protein +++
Time frame: From date of admission to date of discharge from hospital assessed up to 18 months
Positive or negative COVID swab result as assessed by PCR
Time frame: From date of admission to date of discharge from hospital assessed up to 18 months
Positive or negative NPA or throat swab result for respiratory panel as assessed by PCR
Time frame: From date of admission to date of discharge from hospital assessed up to 18 months
Vaccination status
Time frame: At admission to hospital
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 9 Feb 2022.
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.
Jo-Anne Johnson, MRCPCH, PhD principal investigator
Anglia Ruskin University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Paediatric Inflammatory Multisystem Syndrome Temporally Associated With SARS-Cov-2, run by Anglia Ruskin University at 6 sites 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 3 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: finished, as of the sponsor's last update on 9 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
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?
Blood biomarker associated with a cytokine storm - Pro-Beta Natriuretic Peptide (measured in pg/mL). (time frame: From date of admission to date of discharge from hospital assessed up to 18 months). The study lists 3 primary outcomes in all. 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 9 Feb 2022; AzTrials last refreshed its copy on 6 Nov 2026.