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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04382508
Recruitment Status : Enrolling by invitation
First Posted : May 11, 2020
Last Update Posted : May 20, 2020
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
University Hospital Southampton NHS Foundation Trust

Tracking Information
First Submitted Date May 6, 2020
First Posted Date May 11, 2020
Last Update Posted Date May 20, 2020
Actual Study Start Date March 22, 2020
Estimated Primary Completion Date March 21, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 18, 2020)
To describe COVID19 infection in children/adults who are vulnerable for infection in an outpatients setting [ Time Frame: 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
Original Primary Outcome Measures
 (submitted: May 6, 2020)
To describe COVID19 infection in children/adults who are vulnerable for infection in an outpatients setting [ Time Frame: 1 year ]
To describe frequency of cough, fever, diarrhoea, shortness of breath, sore throught, blocked nose, red eyes, headache, joint pain, muscle pain, fatigue, chills, nausea, vomiting, diarrhoea over a year
Change History
Current Secondary Outcome Measures
 (submitted: May 6, 2020)
  • Number of children/adults tested positive for COVID19 [ Time Frame: 1 year ]
    Patient/parent reported positive tests for COVID19
  • Number of children/adults admitted in hospital because of COVID19 [ Time Frame: 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 [ Time Frame: 1 year ]
    Patient/parent reported effect of COVID19 on daily activities
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Coronavirus Infection in Primary or Secondary Immunosuppressed Children and Adults.
Official Title Coronavirus Infection in Primary or Secondary Immunosuppressed Children and Adults.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Children and adults vulnerable for infection due to a condition or to medication they are using.
Condition
  • Immune Suppression
  • Immune Deficiency
  • Infection
  • COVID
  • Children, Adult
Intervention Other: Questionnaire
A weekly questionnaire will be filled in
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: May 6, 2020)
1500
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 21, 2021
Estimated Primary Completion Date March 21, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender Not Provided
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT04382508
Other Study ID Numbers RHM CHI1061
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University Hospital Southampton NHS Foundation Trust
Study Sponsor University Hospital Southampton NHS Foundation Trust
Collaborators
  • 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
PRS Account University Hospital Southampton NHS Foundation Trust
Verification Date March 2020