Coronavirus Infection in Primary or Secondary Immunosuppressed Children and Adults.

Infection Clinical Trial

— ImmunoCOVID  

Official title:

Coronavirus Infection in Primary or Secondary Immunosuppressed Children and Adults.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04382508
• Other study ID #: RHM CHI1061
• Status: Enrolling by invitation
• 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
• 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
• 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

Related Conditions & MeSH terms

• Children, Adult
• Communicable Diseases
• Coronavirus Infections
• COVID
• Immune Deficiency
• Immune Suppression
• Immunologic Deficiency Syndromes
• Infection
• Severe Acute Respiratory Syndrome

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

External Links

•   Study website