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Coronavirus Infection in Primary or Secondary Immunosuppressed Children and Adults.

Coronavirus Infection in Primary or Secondary Immunosuppressed Children and Adults.

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04382508
Acronym
ImmunoCOVID
Enrollment
1500
Registered
2020-05-11
Start date
2020-03-22
Completion date
2021-03-21
Last updated
2020-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Children, Adult, COVID, Immune Deficiency, Immune Suppression, Infection

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.

Interventions

OTHERQuestionnaire

A weekly questionnaire will be filled in

Sponsors

Cambridge University Hospitals NHS Foundation Trust
CollaboratorOTHER
Alder Hey Children's Hospital
CollaboratorUNKNOWN
Birmingham Children's Hospital
CollaboratorOTHER
Bradford Royal Infirmary
CollaboratorOTHER
Bristol Royal Hospital for Children
CollaboratorOTHER
Cardiff and Vale University Health Board
CollaboratorOTHER_GOV
Great North Children's Hospital
CollaboratorUNKNOWN
Great Ormond Street Hospital for Children NHS Foundation Trust
CollaboratorOTHER
Oxford University Hospitals NHS Trust
CollaboratorOTHER
Leeds Teaching Hospitals NHS Trust
CollaboratorUNKNOWN
Norfolk and Norwich University Hospitals NHS Foundation Trust
CollaboratorOTHER
Nottingham Children's Hospital
CollaboratorUNKNOWN
Royal Alexandra Children's Hospital
CollaboratorOTHER
Royal Hospital for Sick Children, Glasgow
CollaboratorUNKNOWN
Royal Manchester Children's Hospital
CollaboratorUNKNOWN
Royal Marsden NHS Foundation Trust
CollaboratorOTHER
Northern Care Alliance NHS Group
CollaboratorOTHER
Royal Sussex County Hospital
CollaboratorOTHER
Sheffield Children's NHS Foundation Trust
CollaboratorOTHER
St George's University Hospital National Health Service Foundation Trust
CollaboratorUNKNOWN
Swansea Bay University Health Board
CollaboratorOTHER
University College London Hospitals
CollaboratorOTHER
University Hospitals Coventry and Warwickshire National Health Service Trust
CollaboratorUNKNOWN
East Lancashire Hospitals National Health Service Trust
CollaboratorUNKNOWN
Imperial College Healthcare National Health Service Trust
CollaboratorUNKNOWN
National Heatlh Service Ayrshire and Arran
CollaboratorOTHER_GOV
University Hospital Southampton NHS Foundation Trust
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

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

Design outcomes

Primary

MeasureTime frameDescription
To describe COVID19 infection in children/adults who are vulnerable for infection in an outpatients setting1 yearTo describe frequency of cough, fever, diarrhoea, shortness of breath, sore throat, blocked nose, red eyes, headache, joint pain, muscle pain, fatigue, chills, nausea, vomiting, diarrhoea over a year

Secondary

MeasureTime frameDescription
Number of children/adults tested positive for COVID191 yearPatient/parent reported positive tests for COVID19
Number of children/adults admitted in hospital because of COVID191 yearPatient/parent reported admissions in hospital because of COVID19
To assess the impact of COVID19 infection on the daily activities of immunosuppressed adults and children1 yearPatient/parent reported effect of COVID19 on daily activities

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026