Condition category
Infections and Infestations
Date applied
13/07/2020
Date assigned
14/07/2020
Last edited
14/07/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

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 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

Trial website

https://www.uhs.nhs.uk/ClinicalResearchinSouthampton/Public-and-patients/Featured-research-studies/Featured-research-ImmunoCOVID19-study.aspx

Contact information

Type

Scientific

Primary contact

Dr Hans De Graaf

ORCID ID

Contact details

University Hospital Southampton NHS FT
Tremona Road
Southampton
SO16 6YD
United Kingdom
+44 (0)2380 777222
hans.degraaf@uhs.nhs.uk

Type

Scientific

Additional contact

Prof Saul Faust

ORCID ID

Contact details

University Hospital Southampton NHS FT
Tremona Road
Southampton
SO16 6YD
United Kingdom
+44 (0)2380 777222
s.n.faust@soton.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

CPMS 45332

Study information

Scientific title

Coronavirus infection in primary or secondary immunosuppressed children

Acronym

Study hypothesis

Children vulnerable to infections are more frequently and more severely affected by SARS-CoV-2.

Ethics approval

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

Study design

Observational qualitative study

Primary study design

Observational

Secondary study design

Qualitative research

Trial setting

Internet

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

COVID-19 (SARS-CoV-2 infection)

Intervention

Eligible 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 type

Other

Phase

Drug names

Primary outcome measure

COVID-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 measures

Over 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 trial start date

16/03/2020

Overall trial end date

15/06/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. 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

Participant type

Patient

Age group

Mixed

Gender

Both

Target number of participants

Planned Sample Size: 400; UK Sample Size: 400

Participant exclusion criteria

Unable to understand English

Recruitment start date

17/03/2020

Recruitment end date

15/03/2021

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Southampton General Hospital
University of Southampton and University Hospital Southampton NHS Foundation Trust Tremona Road
Southampton
SO16 6YD
United Kingdom

Trial participating centre

Aberdeen Royal Infirmary
Aberdeen
AB25 2ZN
United Kingdom

Trial participating centre

Addenbrookes Hosital
Hills Road
Cambridge
CB2 0QQ
United Kingdom

Trial participating centre

Alder Hey Children’s Hosptial
Eaton Road
Liverpool
L12 2AP
United Kingdom

Trial participating centre

The Royal London Hospital
Barts Health NHS Trust Whitechapel Road
London
E1 1FR
United Kingdom

Trial participating centre

Birmingham Women’s and Children’s Hospital
Mindelsohn Way
Birmingham
B15 2TG
United Kingdom

Trial participating centre

Bradford Royal Infirmary
Bradford Teaching Hospitals NHS Foundation Trust Duckworth Lane
Bradford
BD9 6RJ
United Kingdom

Trial participating centre

Bristol Royal Hosptial for Children
University Hospitals Bristol and Weston NHS Foundation Trust Upper Mauldin Street
Bristol
BS2 8BJ
United Kingdom

Trial participating centre

University Hospital of Wales
Cardiff and Vale University Health Board Heath Park
Cardiff
CF14 4XW
United Kingdom

Trial participating centre

Dumfries & Galloway Royal Infirmary
A75 Cargenbridge
Dumfries
DG2 8RX
United Kingdom

Trial participating centre

Burnley General Teaching Hospital
East Lancashire Hospitals NHS Trust Casterton Ave
Burnley
BB10 2PQ
United Kingdom

Trial participating centre

Great North Children's Hospital
Victoria Wing Royal Victoria Infirmary
Newcastle Upon Tyne
NE1 4LP
United Kingdom

Trial participating centre

Great Ormond Street Hospital for Children
Great Ormond Street
London
WC1N 3JH
United Kingdom

Trial participating centre

Guys & St Thomas NHS Foundation Trust
20 St Thomas St
London
SE1 9RS
United Kingdom

Trial participating centre

Hull University Teaching Hospital
Anlaby Rd
Hull
HU3 2JZ
United Kingdom

Trial participating centre

St Mary's Hospital
Imperial College Healthcare Trust The Bays S Wharf Rd Paddington
London
W2 1NY
United Kingdom

Trial participating centre

James Paget University Hospitals NHS Foundation Trust
Lowestoft Road Gorleston-on-Sea
Great Yarmouth
NR31 6LA
United Kingdom

Trial participating centre

Kent Community Health NHS Foundation Trust
The Oast House Hermitage Ct
Maidstone
ME16 9NT
United Kingdom

Trial participating centre

Chorley and South Ribble Hospital
Lancashire Teaching Hospitals NHS Foundation Trust Preston Road
Chorley
PR7 1PP
United Kingdom

Trial participating centre

Leeds Children's Hospital
Leeds General Infirmary Great George St
Leeds
LS1 3EX
United Kingdom

Trial participating centre

Lewisham Hospital
Lewisham High St
London
SE13 6LH
United Kingdom

Trial participating centre

Crosshouse Hospital
NHS Ayrshire & Arran Kilmarnock Rd Crosshouse
Kilmarnock
KA2 0BE
United Kingdom

Trial participating centre

NHS Forth Valley
Castle Business Park
Stirling
FK9 4SW
United Kingdom

Trial participating centre

NHS Lanarkshire
14 Beckford St
Hamilton
ML3 0TA
United Kingdom

Trial participating centre

Ninewells Hospital
NHS Tayside 230 Clepington Rd
Dundee
DD2 1GZ
United Kingdom

Trial participating centre

Norfolk and Norwich University Hospital
Colney Ln
Norwich
NR4 7UY
United Kingdom

Trial participating centre

Royal Oldham Hospital
Northern Care Alliance NHS Group Rochdale Rd
Oldham
OL1 2JH
United Kingdom

Trial participating centre

Nottingham Children's Hospital
Queen's Medical Centre Derby Rd
Nottingham
NG7 2UH
United Kingdom

Trial participating centre

John Radcliffe Hospital
Oxford University Hospitals NHS Trust Headley Way Headington
Oxford
OX3 9DU
United Kingdom

Trial participating centre

Poole Hospital
Poole Hospital NHS Trust Longfleet Rd
Poole
BH15 2JB
United Kingdom

Trial participating centre

Princess Alexandra Hospital for Sick Children
Royal Alexandra Children's Hospital Royal Sussex County Hospital North Dr
Brighton
BN2 5BE
United Kingdom

Trial participating centre

Royal Hospital for Children, Glasgow
Queen Elizabeth University Hospital 1345 Govan Rd
Glasgow
G51 4TF
United Kingdom

Trial participating centre

Royal Hospital for Sick Children, Edinburgh
9 Sciennes Rd
Edinburgh
EH9 1LF
United Kingdom

Trial participating centre

Royal Manchester Children's Hospital
Oxford Rd
Manchester
M13 9WL
United Kingdom

Trial participating centre

The Royal Marsden Hospital
Royal Marsden NHS Foundation Trust Downs Rd
Sutton
SM2 5PT
United Kingdom

Trial participating centre

Royal Sussex County Hospital
Eastern Rd
Brighton
BN2 5BE
United Kingdom

Trial participating centre

Royal United Hospital
Combe Park
Bath
BA1 3NG
United Kingdom

Trial participating centre

Salisbury District Hospital
Salisbury NHS Foundation Trust Odstock Rd
Salisbury
SP2 8BJ
United Kingdom

Trial participating centre

Sheffield Children's NHS Foundation Trust
Clarkson St Broomhall
Sheffield
S10 2TH
United Kingdom

Trial participating centre

Shrewsbury & Telford Hospital
Mytton Oak Rd
Shrewsbury
SY3 8XQ
United Kingdom

Trial participating centre

St George's University Hospital
St George's University Hospital NHS Foundation Trust Blackshaw Rd
London
SW17 0QT
United Kingdom

Trial participating centre

Swansea Bay University Local Health Board
Port Talbot
SA12 7BR
United Kingdom

Trial participating centre

University College Hospital
University College London Hospitals NHS FT 235 Euston Rd Bloomsbury
London
NW1 2BU
United Kingdom

Trial participating centre

University Hospitals Coventry and Warwickshire National Health Service Trust
Clifford Bridge Rd
Coventry
CV2 2DX
United Kingdom

Trial participating centre

University Hospitals of North Midlands NHS Trust
Weston Rd
Stafford
ST16 3SA
United Kingdom

Trial participating centre

Walsall Manor Hospital
Walsall Healthcare NHS Trust Moat Rd
Walsall
WS2 9PS
United Kingdom

Sponsor information

Organisation

University Hospital Southampton NHS Foundation Trust

Sponsor details

Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
+44 (0)23 8120 5424
sharon.davies-dear@uhs.nhs.uk

Sponsor type

Hospital/treatment centre

Website

http://www.uhs.nhs.uk/home.aspx

Funders

Funder type

Research council

Funder name

British Paediatric Allergy, Immunity and Infection Group

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement:
All data generated or analysed during this study will be included in the subsequent results publication.

Intention to publish date

01/06/2022

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

13/07/2020: Trial’s existence confirmed by the National Institute for Health Research (NIHR).