Coronavirus Infection in Primary or Secondary Immunosuppressed Children and Adults.

• Conditions: COVID; Immune Suppression; Infection; Children, Adult; Immune Deficiency

• Registration Number: NCT04382508
• Lead Sponsor: University Hospital Southampton NHS Foundation Trust

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.

Study Timeline

• Status Verified: 2020-03
• Study Start: 2020-03-22
• Study First Submitted: 2020-05-06
• Study First Submitted QC: 2020-05-06
• Study First Posted: 2020-05-11
• Last Update Submitted: 2020-05-18
• Last Update Posted: 2020-05-20
• Primary Completion: 2021-03-21
• Study Completion: 2021-03-21

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Not specified
• Target Recruitment: 1500

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To describe COVID19 infection in children/adults who are vulnerable for infection in an outpatients setting	1 year	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

Secondary Outcome Measures

Name	Time	Method
Number of children/adults tested positive for COVID19	1 year	Patient/parent reported positive tests for COVID19
Number of children/adults admitted in hospital because of COVID19	1 year	Patient/parent reported admissions in hospital because of COVID19
To assess the impact of COVID19 infection on the daily activities of immunosuppressed adults and children	1 year	Patient/parent reported effect of COVID19 on daily activities

Trial Locations

Locations (1)

University Hospital Southampton NHS FT; 🇬🇧 Southampton, Hampshire, United Kingdom