Clinical trial NCT04382508: Coronavirus Infection in Primary or Secondary Immunosuppressed Children and Adults.
Official title: Coronavirus Infection in Primary or Secondary Immunosuppressed Children and Adults.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Immune Suppression
Immune Deficiency
Infection
COVID
Children, Adult
Lead sponsor: University Hospital Southampton NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Cambridge University Hospitals NHS Foundation Trust
name: Alder Hey Children's Hospital
name: Birmingham Children's Hospital
name: Bradford Royal Infirmary
name: Bristol Royal Hospital for Children
name: Cardiff and Vale University Health Board
name: Great North Children's Hospital
name: Great Ormond Street Hospital for Children NHS Foundation Trust
name: Oxford University Hospitals NHS Trust
name: Leeds Teaching Hospitals NHS Trust
name: Norfolk and Norwich University Hospitals NHS Foundation Trust
name: Nottingham Children's Hospital
name: Royal Alexandra Children's Hospital
name: Royal Hospital for Sick Children, Glasgow
name: Royal Manchester Children's Hospital
name: Royal Marsden NHS Foundation Trust
name: Northern Care Alliance NHS Group
name: Royal Sussex County Hospital
name: Sheffield Children's NHS Foundation Trust
name: St George's University Hospital National Health Service Foundation Trust
name: Swansea Bay University Health Board
name: University College London Hospitals
name: University Hospitals Coventry and Warwickshire National Health Service Trust
name: East Lancashire Hospitals National Health Service Trust
name: Imperial College Healthcare National Health Service Trust
name: National Heatlh Service Ayrshire and Arran
First posted: 2020-05-11
Enrollment: 1500
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children and adults vulnerable for infection due to a condition or to medication they are using.

Brief summary: A weekly questionnaire is sent to patients and parents of patients who are vulnerable for infections. Possible symptoms of COVID19 are asked for and use of healthcare services and testing for COVID19. Weekly reports are being send to the national institutions to update advice given to this group.

Detailed description: This study is designed to allow immunosuppressed children, their parents or adult patients to self-record their experiences of COVID-19 and other viral respiratory illnesses. Patients, parents and of immunosuppressed patients and patients aged 16-17 yrs will be provided with online information and asked to fill in online questionnaires at baseline and weekly thereafter. Information collected includes 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. This study is complementary to, and not overlapping with, the global ISARIC World Health Organisation protocol that will be studying COVID-19 cases admitted to all National Health Service (NHS) Trusts, including all children.

Eligibility criteria: Inclusion Criteria:

* Children part: Parent of immunosuppressed patient aged \<16 years or immunosuppressed patient aged 16-17 years
* Adult part: Immunosuppressed patient aged \>17 years
* Family or themselves able to complete the questionnaire which will be in English (due to current resources available translation will not be possible)
* Reliable access to the internet

Exclusion Criteria:

* Unable to understand English

Primary outcomes:
measure: To describe COVID19 infection in children/adults who are vulnerable for infection in an outpatients setting
timeFrame: 1 year
Secondary outcomes:
measure: Number of children/adults tested positive for COVID19
timeFrame: 1 year
measure: Number of children/adults admitted in hospital because of COVID19
timeFrame: 1 year
measure: To assess the impact of COVID19 infection on the daily activities of immunosuppressed adults and children
timeFrame: 1 year
Other outcomes:
Locations:
city: Southampton
country: United Kingdom
facility: University Hospital Southampton NHS FT
state: Hampshire
Study officials:
affiliation: University Hospital Southampton NHS Foundation Trust
name: Hans de Graaf, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shaunak M, Patel R, Driessens C, Mills L, Leahy A, Gbesemete D, Owens DR, Lucas JS, Faust SN, de Graaf H; ImmunoCOVID19 study group. COVID-19 symptom surveillance in immunocompromised children and young people in the UK: a prospective observational cohort study. BMJ Open. 2021 Mar 17;11(3):e044899. doi: 10.1136/bmjopen-2020-044899.