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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
Swansae 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

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
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.

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Study Type : Observational
Estimated 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 : March 22, 2020
Estimated Primary Completion Date : March 21, 2021
Estimated Study Completion Date : March 21, 2021

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: Questionnaire
    A weekly questionnaire will be filled in


Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Number of children/adults tested positive for COVID19 [ Time Frame: 1 year ]
    Patient/parent reported positive tests for COVID19

  2. Number of children/adults admitted in hospital because of COVID19 [ Time Frame: 1 year ]
    Patient/parent reported admissions in hospital because of COVID19

  3. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sampling Method:   Non-Probability Sample
Study Population
Children and adults vulnerable for infection due to a condition or to medication they are using.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04382508


Locations
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United Kingdom
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
Swansae 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
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Principal Investigator: Hans de Graaf, MD University Hospital Southampton NHS Foundation Trust
Additional Information:
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Responsible Party: University Hospital Southampton NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT04382508    
Other Study ID Numbers: RHM CHI1061
First Posted: May 11, 2020    Key Record Dates
Last Update Posted: May 20, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Coronavirus Infections
Severe Acute Respiratory Syndrome
Immunologic Deficiency Syndromes
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Immune System Diseases