Coronavirus infection in immunosuppressed children

ISRCTN ISRCTN10175886
DOI https://doi.org/10.1186/ISRCTN10175886
ClinicalTrials.gov number NCT04382508
Secondary identifying numbers CPMS 45332
Submission date
13/07/2020
Registration date
14/07/2020
Last edited
11/03/2022
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
This study is designed to allow families of immunosuppressed children and young people to self-record their experiences of COVID-19 and other viral respiratory illnesses during the COVID-19 epidemic.

Who can participate?
Parents of immunosuppressed patients and young people aged 16-17 years who are immunosuppressed

What does the study involve?
Participants will be provided with online information and asked to fill in online questionnaires at baseline and weekly thereafter. Information collected will include immune-system affecting medication, symptoms, contact with health care providers, test results and impact on daily activities. Data will be collected and analysed weekly to be able to monitor any potential risk factors for severe disease.

What are the possible benefits and risks of participating?
None

Where is the study run from?
Southampton General Hospital (UK)

When is the study starting and how long is it expected to run for?
March 2020 to March 2022 (updated 02/03/2021, previously: June 2021)

Who is funding the study?
British Paediatric Allergy, Immunity and Infection Group

Who is the main contact?
Dr Hans De Graaf, hans.degraaf@uhs.nhs.uk

Study website

Contact information

Dr Hans De Graaf
Scientific

University Hospital Southampton NHS FT
Tremona Road
Southampton
SO16 6YD
United Kingdom

+44 (0)2380 777222
hans.degraaf@uhs.nhs.uk
Prof Saul Faust
Scientific

University Hospital Southampton NHS FT
Tremona Road
Southampton
SO16 6YD
United Kingdom

+44 (0)2380 777222
s.faust@soton.ac.uk

Study information

Study designObservational qualitative study
Primary study designObservational
Secondary study designQualitative research
Study setting(s)Internet/virtual
Study typeOther
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleCoronavirus infection in primary or secondary immunosuppressed children
Study objectivesChildren vulnerable to infections are more frequently and more severely affected by SARS-CoV-2.
Ethics approval(s)Approved 17/03/2020, Yorkshire & The Humber - Leeds West Research Ethics Committee (NHSBT Newcastle Blood Donor Centre, Holland Drive, Newcastle upon Tyne, NE2 4NQ, UK; no telephone number provided; leedswest.rec@hra.nhs.uk), ref: 20/YH/0110
Health condition(s) or problem(s) studiedCOVID-19 (SARS-CoV-2 infection)
InterventionEligible patients will be identified by the team responsible for their clinical care. Patients and/or parents will be contacted NHS clinical methods with a weblink directing them to the study website. This website will provide information about the study, an email address to ask questions if required and links to current NHS, Dept of Health and Social Care, and Public Health England COVID-19 advice.

If the patient and/or parent are willing to participate they will complete an online consent form. Data of enrolled patients will be checked with their health records to confirm eligibility.

Data will be collected via online questionnaires. The first questionnaire will include information about the patient, their disease and the medication they are using. Following this they will be sent a link each week inviting them to fill in an online questionnaire. These weekly questionnaires will monitor possible symptoms of COVID-19 (and other current respiratory tract illnesses), results of COVID-19 testing, contact with people diagnosed with COVID-19, general practitioner (GP) or health care attendance, hospital admission, incidences of self-isolation, the stopping or postponing of immunosuppressive drugs, effects on daily life, possible flare of any auto-immune disease (in relevant patients) and parental anxiety. They will also be provided with up to date information and advice and an email address for any further questions.

It will be clear to families that they should continue to link to and liaise with their paediatric speciality clinical teams as per normal routine and emergency care and not through the study helpline.

All participants will be provided with a lay summary of results when the study is completed.
Intervention typeOther
Primary outcome measureCOVID-19 infection in children/adults assessed by online questionnaire as frequency of: cough, fever, diarrhoea, shortness of breath, sore throat, blocked nose, red eyes, headache, joint pain, muscle pain, fatigue, chills, nausea, vomiting, over a year
Secondary outcome measuresOver the 1 year period:
1. Number of children/adults tested positive for COVID-19 measured using patient records
2. Patient/parent reported positive tests for COVID-19 measured using the online questionnaire
3. Number of children/adults admitted in hospital because of COVID-19 measured using patient records
4. Patient/parent reported admissions in hospital because of COVID-19 measured using the online questionnaire
5. To assess the impact of COVID-19 infection on the daily activities of immunosuppressed adults and children measured using patient records
6. Patient/parent reported effect of COVID-19 on daily activities measured using the online questionnaire
Overall study start date16/03/2020
Completion date17/03/2022

Eligibility

Participant type(s)Patient
Age groupMixed
SexBoth
Target number of participantsPlanned Sample Size: 400; UK Sample Size: 400
Total final enrolment2900
Key inclusion criteria1. Parent of immunosuppressed patient aged <16 years or immunosuppressed patient aged 16-17 years
2. Family able to complete the questionnaire which will be in English (due to current resources available translation will not be possible)
3. Reliable access to the internet
Key exclusion criteriaUnable to understand English
Date of first enrolment17/03/2020
Date of final enrolment15/03/2021

Locations

Countries of recruitment

  • England
  • Scotland
  • United Kingdom
  • Wales

Study participating centres

Southampton General Hospital
University of Southampton and University Hospital Southampton NHS Foundation Trust
Tremona Road
Southampton
SO16 6YD
United Kingdom
Aberdeen Royal Infirmary
Aberdeen
AB25 2ZN
United Kingdom
Addenbrookes Hosital
Hills Road
Cambridge
CB2 0QQ
United Kingdom
Alder Hey Children’s Hosptial
Eaton Road
Liverpool
L12 2AP
United Kingdom
The Royal London Hospital
Barts Health NHS Trust
Whitechapel Road
London
E1 1FR
United Kingdom
Birmingham Women’s and Children’s Hospital
Mindelsohn Way
Birmingham
B15 2TG
United Kingdom
Bradford Royal Infirmary
Bradford Teaching Hospitals NHS Foundation Trust
Duckworth Lane
Bradford
BD9 6RJ
United Kingdom
Bristol Royal Hosptial for Children
University Hospitals Bristol and Weston NHS Foundation Trust
Upper Mauldin Street
Bristol
BS2 8BJ
United Kingdom
University Hospital of Wales
Cardiff and Vale University Health Board
Heath Park
Cardiff
CF14 4XW
United Kingdom
Dumfries & Galloway Royal Infirmary
A75
Cargenbridge
Dumfries
DG2 8RX
United Kingdom
Burnley General Teaching Hospital
East Lancashire Hospitals NHS Trust
Casterton Ave
Burnley
BB10 2PQ
United Kingdom
Great North Children's Hospital
Victoria Wing
Royal Victoria Infirmary
Newcastle Upon Tyne
NE1 4LP
United Kingdom
Great Ormond Street Hospital for Children
Great Ormond Street
London
WC1N 3JH
United Kingdom
Guys & St Thomas NHS Foundation Trust
20 St Thomas St
London
SE1 9RS
United Kingdom
Hull University Teaching Hospital
Anlaby Rd
Hull
HU3 2JZ
United Kingdom
St Mary's Hospital
Imperial College Healthcare Trust
The Bays
S Wharf Rd
Paddington
London
W2 1NY
United Kingdom
James Paget University Hospitals NHS Foundation Trust
Lowestoft Road
Gorleston-on-Sea
Great Yarmouth
NR31 6LA
United Kingdom
Kent Community Health NHS Foundation Trust
The Oast House
Hermitage Ct
Maidstone
ME16 9NT
United Kingdom
Chorley and South Ribble Hospital
Lancashire Teaching Hospitals NHS Foundation Trust
Preston Road
Chorley
PR7 1PP
United Kingdom
Leeds Children's Hospital
Leeds General Infirmary
Great George St
Leeds
LS1 3EX
United Kingdom
Lewisham Hospital
Lewisham High St
London
SE13 6LH
United Kingdom
Crosshouse Hospital
NHS Ayrshire & Arran
Kilmarnock Rd
Crosshouse
Kilmarnock
KA2 0BE
United Kingdom
NHS Forth Valley
Castle Business Park
Stirling
FK9 4SW
United Kingdom
NHS Lanarkshire
14 Beckford St
Hamilton
ML3 0TA
United Kingdom
Ninewells Hospital
NHS Tayside
230 Clepington Rd
Dundee
DD2 1GZ
United Kingdom
Norfolk and Norwich University Hospital
Colney Ln
Norwich
NR4 7UY
United Kingdom
Royal Oldham Hospital
Northern Care Alliance NHS Group
Rochdale Rd
Oldham
OL1 2JH
United Kingdom
Nottingham Children's Hospital
Queen's Medical Centre
Derby Rd
Nottingham
NG7 2UH
United Kingdom
John Radcliffe Hospital
Oxford University Hospitals NHS Trust
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom
Poole Hospital
Poole Hospital NHS Trust
Longfleet Rd
Poole
BH15 2JB
United Kingdom
Princess Alexandra Hospital for Sick Children
Royal Alexandra Children's Hospital
Royal Sussex County Hospital
North Dr
Brighton
BN2 5BE
United Kingdom
Royal Hospital for Children, Glasgow
Queen Elizabeth University Hospital
1345 Govan Rd
Glasgow
G51 4TF
United Kingdom
Royal Hospital for Sick Children, Edinburgh
9 Sciennes Rd
Edinburgh
EH9 1LF
United Kingdom
Royal Manchester Children's Hospital
Oxford Rd
Manchester
M13 9WL
United Kingdom
The Royal Marsden Hospital
Royal Marsden NHS Foundation Trust
Downs Rd
Sutton
SM2 5PT
United Kingdom
Royal Sussex County Hospital
Eastern Rd
Brighton
BN2 5BE
United Kingdom
Royal United Hospital
Combe Park
Bath
BA1 3NG
United Kingdom
Salisbury District Hospital
Salisbury NHS Foundation Trust
Odstock Rd
Salisbury
SP2 8BJ
United Kingdom
Sheffield Children's NHS Foundation Trust
Clarkson St
Broomhall
Sheffield
S10 2TH
United Kingdom
Shrewsbury & Telford Hospital
Mytton Oak Rd
Shrewsbury
SY3 8XQ
United Kingdom
St George's University Hospital
St George's University Hospital NHS Foundation Trust
Blackshaw Rd
London
SW17 0QT
United Kingdom
Swansea Bay University Local Health Board
Port Talbot
SA12 7BR
United Kingdom
University College Hospital
University College London Hospitals NHS FT
235 Euston Rd
Bloomsbury
London
NW1 2BU
United Kingdom
University Hospitals Coventry and Warwickshire National Health Service Trust
Clifford Bridge Rd
Coventry
CV2 2DX
United Kingdom
University Hospitals of North Midlands NHS Trust
Weston Rd
Stafford
ST16 3SA
United Kingdom
Walsall Manor Hospital
Walsall Healthcare NHS Trust
Moat Rd
Walsall
WS2 9PS
United Kingdom

Sponsor information

University Hospital Southampton NHS Foundation Trust
Hospital/treatment centre

Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
England
United Kingdom

+44 (0)23 8120 5424
sharon.davies-dear@uhs.nhs.uk
http://www.uhs.nhs.uk/home.aspx
ROR logo https://ror.org/0485axj58

Funders

Funder type

Research council

British Paediatric Allergy, Immunity and Infection Group

No information available

Results and Publications

Intention to publish date01/06/2022
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryOther
Publication and dissemination planPlanned publication in a high-impact peer-reviewed journal.
IPD sharing planAll data generated or analysed during this study will be included in the subsequent results publication.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 17/03/2021 11/03/2022 Yes No
HRA research summary 26/07/2023 No No

Editorial Notes

11/03/2022: The following changes have been made:
1. The ClinicalTrials.gov number has been added.
2. The overall trial end date has been changed from 18/03/2022 to 17/03/2022.
3. The total final enrolment number has been added.
4. Publication reference added.
02/03/2021: The following changes were made to the trial record:
1. The overall end date was changed from 15/06/2021 to 18/03/2022.
2. The plain English summary was updated to reflect these changes.
04/01/2021: Internal revew.
13/07/2020: Trial’s existence confirmed by the National Institute for Health Research (NIHR).

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