Status:
UNKNOWN
Testing the Accuracy of a Digital Test to Diagnose Covid-19
Lead Sponsor:
King's College London
Collaborating Sponsors:
Zoe Global Limited
Department of Health, United Kingdom
Conditions:
Covid-19
Eligibility:
All Genders
18+ years
Brief Summary
The Covid-19 viral pandemic has caused significant global losses and disruption to all aspects of society. One of the major difficulties in controlling the spread of this coronavirus has been the dela...
Detailed Description
The Covid-19 viral pandemic has caused significant global losses and disruption to all aspects of society (including health, education, and business and economic security). One of the major difficulti...
Eligibility Criteria
Inclusion
- Study Inclusion Criteria - app users will be eligible to join the study if they:
- Are based in the UK (are using the UK version of the Covid-19 Symptom Study app, and have listed a UK postcode)
- Are the primary app user (are reporting directly for themselves)
- Are at least 18 years of age
- Have not tested positive for a Covid-19 test before (but may have been tested)
- Study Exclusion Criteria - participants are ineligible for the study if they:
- Do not meet inclusion criteria
- Do not provide informed consent to participate
- Participants will be subject to further screening to identify them as eligible for swab testing during the course of the study.
- Swab inclusion criteria - participants will be eligible for swab testing if they:
- Have reported in the app at least once in the previous 3 days (days -2 to 0), and at least two times in the previous 9 days (days -8 to 0). All reports must be healthy (i.e. not experiencing any symptoms).
- On the previous day (day 1), have reported that they are experiencing at least one symptom described in the app. Symptoms in the app are updated when deemed appropriate by study investigators using evidence based reports in the scientific and medical field.
- Have answered the phenotype fields required for the prediction model with physiologically plausible values.
- Swab exclusion criteria - participants are ineligible for swab testing if they:
- Are asymptomatic
- Do not satisfy the inclusion criteria for testing.
- Insufficient testing capacity:
- If insufficient testing capacity is available for the study population as described, then recruitment will be prioritised according to:
- Firstly, most recent final healthy report before reporting symptoms
- Secondly, highest number of healthy reports during the previous 9 days before reporting symptoms
- Thirdly, randomised selection to stratify between participants of equal priority according to the first two rules above.
- Excess testing capacity:
- If excess testing capacity is available beyond the study population as described, then inclusion criteria will be expanded in order to adequately sample across under-represented population groups.
- Specifically, on day 7 of each validation phase, investigators will assess:
- What excess testing capacity is available, if any
- Which subgroups are under-represented compared to their proportion in the UK population (as best as can be established given that some participants may not have completed some phenotype fields):
- (i) Age decade (ii) Sex (iii) Ethnicity (iv) BMI category
- For underrepresented groups, investigators may additionally recruit participants with only one report during the previous 3 days (days -2 to 0) and no other report during the previous 9 days (days -8 to 0).
Exclusion
Key Trial Info
Start Date :
June 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 10 2023
Estimated Enrollment :
1000000 Patients enrolled
Trial Details
Trial ID
NCT04407585
Start Date
June 1 2020
End Date
May 10 2023
Last Update
March 31 2022
Active Locations (1)
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1
King's College London
London, United Kingdom, SE1 9NH