ImmunoCOVID: Coronavirus Infection in Primary or Secondary Immunosuppressed Children and Adults.

Sponsor

University Hospital Southampton NHS Foundation Trust (Other)

Overall Status

Unknown status

CT.gov ID

NCT04382508

Collaborator

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

1,500

Enrollment

Location

Anticipated Duration (Months)

125.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Immune Suppression Immune Deficiency Infection COVID Children, Adult	Other: Questionnaire

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 Design

Study Type:

Observational

Anticipated Enrollment :

1500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Coronavirus Infection in Primary or Secondary Immunosuppressed Children and Adults.

Actual Study Start Date :

Mar 22, 2020

Anticipated Primary Completion Date :

Mar 21, 2021

Anticipated Study Completion Date :

Mar 21, 2021

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Southampton NHS FT	Southampton	Hampshire	United Kingdom	SO16 6YD

Sponsors and Collaborators

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

Investigators

Principal Investigator: Hans de Graaf, MD, University Hospital Southampton NHS Foundation Trust

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital Southampton NHS Foundation Trust

ClinicalTrials.gov Identifier:

NCT04382508

Other Study ID Numbers:

RHM CHI1061

First Posted:

May 11, 2020

Last Update Posted:

May 20, 2020

Last Verified:

Mar 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Infections

Communicable Diseases

Coronavirus Infections

Immunologic Deficiency Syndromes

Study Results

No Results Posted as of May 20, 2020