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

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.

Study Overview

• Status: Unknown
• Conditions: COVID; Infection; Immune Deficiency; Immune Suppression; Children, Adult
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 1500

Contacts and Locations

Study Locations

• United Kingdom
  • Hampshire
    • Southampton, Hampshire, United Kingdom, SO16 6YD
      • University Hospital Southampton NHS FT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Children and adults vulnerable for infection due to a condition or to medication they are using.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of children/adults tested positive for COVID19	Patient/parent reported positive tests for COVID19	1 year
Number of children/adults admitted in hospital because of COVID19	Patient/parent reported admissions in hospital because of COVID19	1 year
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

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Shaunak M, Patel R, Driessens C, Mills L, Leahy A, Gbesemete D, Owens DR, Lucas JS, Faust SN, de Graaf H; ImmunoCOVID19 study group. COVID-19 symptom surveillance in immunocompromised children and young people in the UK: a prospective observational cohort study. BMJ Open. 2021 Mar 17;11(3):e044899. doi: 10.1136/bmjopen-2020-044899.

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2020
• Primary Completion (Anticipated): March 21, 2021
• Study Completion (Anticipated): March 21, 2021

Study Registration Dates

• First Submitted: May 6, 2020
• First Submitted That Met QC Criteria: May 6, 2020
• First Posted (Actual): May 11, 2020

Study Record Updates

• Last Update Posted (Actual): May 20, 2020
• Last Update Submitted That Met QC Criteria: May 18, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Immune System Diseases; Disease Attributes; Coronavirus Infections; Infections; Communicable Diseases; Immunologic Deficiency Syndromes
• Other Study ID Numbers: RHM CHI1061

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No