NCT04382508

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 22, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 11, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 21, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 21, 2021

Completed
Last Updated

May 20, 2020

Status Verified

March 1, 2020

Enrollment Period

12 months

First QC Date

May 6, 2020

Last Update Submit

May 18, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Number of children/adults tested positive for COVID19

    1 year

  • Number of children/adults admitted in hospital because of COVID19

    1 year

  • To assess the impact of COVID19 infection on the daily activities of immunosuppressed adults and children

    1 year

Interventions

A weekly questionnaire will be filled in

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Unable to understand English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Southampton NHS FT

Southampton, Hampshire, SO16 6YD, United Kingdom

Location

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

Immunologic Deficiency SyndromesInfections

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Hans de Graaf, MD

    University Hospital Southampton NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2020

First Posted

May 11, 2020

Study Start

March 22, 2020

Primary Completion

March 21, 2021

Study Completion

March 21, 2021

Last Updated

May 20, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations