Immune SuppressionImmunoCOVIDNCT04382508
Coronavirus Infection in Primary or Secondary Immunosuppressed Children and Adults.
An observational study of Immune Suppression and Immune Deficiency, run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Immune Suppression, Immune Deficiency, Infection
- What is being tested?
- Questionnaire
- How many people
- 1,500 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 Mar 2020to 21 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Child, Adult, Older adult
Study population: Children and adults vulnerable for infection due to a condition or to medication they are using.
Who may be able to join
- 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
Who cannot join
- Unable to understand English
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospital Southampton NHS FT
Southampton, Hampshire, SO16 6YD
About this study
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.
Read the 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.
- Conditions
- Immune Suppression, Immune Deficiency, Infection, COVID, Children, Adult
- Being tested
- Questionnaire
- Medical subject headings
- Immunologic Deficiency Syndromes, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
A weekly questionnaire will be filled in
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (3)
Number of children/adults tested positive for COVID19
Patient/parent reported positive tests for COVID19
Measured: 1 year
Number of children/adults admitted in hospital because of COVID19
Patient/parent reported admissions in hospital because of COVID19
Measured: 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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2020
- Study start22 Mar 2020
- Primary completion21 Mar 2021 (estimated)
- Study completion21 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Immune SuppressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Southampton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Cambridge University Hospitals NHS Foundation Trust, Alder Hey Children's NHS Foundation Trust, 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, 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 Hospitals NHS 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
- Responsible party
- Sponsor
- Investigators
- Hans de Graaf, MD, Principal investigator, University Hospital Southampton NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04382508
- Sponsor's protocol ID
- RHM CHI1061
- Acronym
- ImmunoCOVID
- Status last verified
- Mar 2020
- First submitted
- 6 May 2020
- Last updated
- 20 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 33737439
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronavirus Infection in Primary or Secondary Immunosuppressed Children and Adults.
- ClinicalTrials.gov ID
- NCT04382508
- Acronym / sponsor ID
- ImmunoCOVID / RHM CHI1061
- Conditions
- Immune Suppression, Immune Deficiency, Infection, COVID, Children, Adult
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- University Hospital Southampton NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Cambridge University Hospitals NHS Foundation Trust, Alder Hey Children's NHS Foundation Trust, 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, 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 Hospitals NHS 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
- Study start
- 22 Mar 2020 (actual)
- Primary completion
- 21 Mar 2021 (estimated)
- Study completion
- 21 Mar 2021 (estimated)
- First posted
- 11 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Age groups
- Child, Adult, Older adult
- Study population
- Children and adults vulnerable for infection due to a condition or to medication they are using.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Unable to understand English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireA weekly questionnaire will be filled in | Other | – |
Primary outcome
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
3 secondary outcomes
Number of children/adults tested positive for COVID19
Time frame: 1 year
Number of children/adults admitted in hospital because of COVID19
Time frame: 1 year
To assess the impact of COVID19 infection on the daily activities of immunosuppressed adults and children
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2020.
- Derived from this study: PubMed 33737439Shaunak 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hans de Graaf, MD principal investigator
University Hospital Southampton NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Immune Suppression and Immune Deficiency, run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To describe COVID19 infection in children/adults who are vulnerable for infection in an outpatients setting (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04382508, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2020.