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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04382508
Other study ID # RHM CHI1061
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date March 22, 2020
Est. completion date March 21, 2021

Study information

Verified date March 2020
Source University Hospital Southampton NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 1500
Est. completion date March 21, 2021
Est. primary completion date March 21, 2021
Accepts healthy volunteers
Gender All
Age group N/A and older
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

Study Design


Intervention

Other:
Questionnaire
A weekly questionnaire will be filled in

Locations

Country Name City State
United Kingdom University Hospital Southampton NHS FT Southampton Hampshire

Sponsors (27)

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

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary To describe COVID19 infection in children/adults who are vulnerable for infection in an outpatients setting To 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 1 year
Secondary Number of children/adults tested positive for COVID19 Patient/parent reported positive tests for COVID19 1 year
Secondary Number of children/adults admitted in hospital because of COVID19 Patient/parent reported admissions in hospital because of COVID19 1 year
Secondary To assess the impact of COVID19 infection on the daily activities of immunosuppressed adults and children Patient/parent reported effect of COVID19 on daily activities 1 year
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