Condition category
Infections and Infestations
Date applied
19/06/2020
Date assigned
22/06/2020
Last edited
22/06/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
COVID-19 is a condition caused by the coronavirus (called SARS-CoV-2) that was first identified in late 2019. This virus can infect the respiratory (breathing) system. Some people do not have symptoms but can carry the virus and pass it on to others. People who have developed the condition may develop a fever and/or a continuous cough among other symptoms. This can develop into pneumonia. Pneumonia is a chest infection where the small air pockets of the lungs, called alveoli, fill with liquid and make it more difficult to breathe.

In 2020, the virus has spread to many countries around the world and neither a vaccine against the virus or specific treatment for COVID-19 has yet been developed. As of March 2020, it is advised that people minimize travel and social contact, and regularly wash their hands to reduce the spread of the virus.

Groups who are at a higher risk from infection with the virus, and therefore of developing COVID-19, include people aged over 70 years, people who have long-term health conditions (such as asthma or diabetes), people who have a weakened immune system and people who are pregnant. People in these groups, and people who might come into contact with them, can reduce this risk by following the up-to-date advice to reduce the spread of the virus.

Antibodies detected by blood tests indicate that a person had an immune response to SARS-CoV-2. Antibody tests are important to confirm prior infection, including in individuals with few or no symptoms.
The Panbio™ COVID-19 IgG/IgM Rapid Test is a rapid test that uses a small drop of blood for the qualitative detection of IgG and IgM antibodies to SARS-CoV-2 in human serum, plasma, venous and capillary whole blood. The test is interpreted 10-20 minutes after sample application.
This study will evaluate the performance of the Panbio COVID-19 IgG/IgM test.

Who can participate?
Adults over 18 years who are known to have been infected with SARS-CoV-2, and participants who have not been infected with SARS-CoV-2.

What does the study involve?
Participants will have several different blood tests performed.

What are the possible benefits and risks of participating?
It is possible that the collection of blood through venipuncture and capillary finger-stick could cause discomfort. However, as these are routine medical procedures and the samples will be obtained by trained medical personnel, the discomfort is likely to be minimized.
COVID-19 transmission is a risk to the participants. However, convalescent patients are not expected to be transmitting virus. There is a risk, albeit low, that a symptomatic patients in the control group will be carrying COVID-19. All operations will be conducted under strict social distancing to minimize the risk of transmission.

Where is the study run from?
The Royal London Hospital (UK)

When is the study starting and how long is it expected to run for?
April 2020 to July 2020

Who is funding the study?
Abbott Rapid Diagnostics (Germany)

Who is the main contact?
Prof. Patrick T. Kennedy, p.kennedy@qmul.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Patrick T. Kennedy

ORCID ID

Contact details

Barts Liver Centre
Immunobiology
Blizard Institute
Barts and The London SMD
QMUL
4 Newark Street
London
E1 2AT
United Kingdom
+44 (0)207 882 6187
p.kennedy@qmul.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

CLDG-0503, IRAS 283040

Study information

Scientific title

Panbio™ COVID-19 IgG/IgM rapid test device matrix equivalence study: evaluating test performance in comparison with a laboratory reference method using venous whole blood, serum and plasma as well as capillary whole blood from adult participants

Acronym

Study hypothesis

The performance of the Panbio COVID-19 IgG/IgM test using the matrices fingerstick whole blood, venous whole blood and serum is similar to the test performance using venous plasma.

Ethics approval

Approved 22/04/2020, South Central - Berkshire Research Ethics Committee (Bristol REC Centre, Whitefriars, BS1 2NT, UK; +44 (0)207 1048046; berkshire.rec@hra.nhs.uk), ref: 20/SC/0191

Study design

Observational case-control study

Primary study design

Observational

Secondary study design

Case-control study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

COVID-19 (SARS-CoV-2 infection) past exposure

Intervention

All participants provided a fingerstick capillary whole blood sample as well as a venous blood sample. All participants had a fingerstick capillary whole blood sample, a venous EDTA whole blood sample, a venous EDTA plasma sample and a venous serum sample tested using the Panbio COVID-19 IgG/IgM Rapid Test Device. The results are evaluated using laboratory based SARS-CoV-2 IgM and IgG reference tests.

Intervention type

Other

Phase

Drug names

Primary outcome measure

User’s test result interpretation of the Panbio™ COVID-19 IgG/IgM rapid test device at 10 minutes and at 20 minutes after sample application, using fingerstick whole blood, venous whole blood and venous serum, in comparison with venous plasma

Secondary outcome measures

1. User’s test result interpretation of the Panbio™ COVID-19 IgG/IgM rapid test device at 10 minutes and at 20 minutes after sample application using fingerstick whole blood, venous whole blood, venous serum and venous plasma, in comparison with laboratory reference tests
2. Prevalence of COVID-19 antibodies in all participants at the time of enrolment, as determined by a laboratory-based test

Overall trial start date

06/04/2020

Overall trial end date

03/07/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged 18 years or older
2. Known to have been infected with SARS-CoV-2, or who have not been infected with SARS-CoV-2
3. Agrees to complete all aspects of the study

Participant type

Mixed

Age group

Adult

Gender

Both

Target number of participants

The intended study population will include at least 103 evaluable participants who are known to have been infected with SARS-CoV-2, and at least 103 evaluable participants who have not been infected with SARS-CoV-2.

Participant exclusion criteria

1. Belongs to a study group that has been filled
2. Has already participated in this study on a previous occasion
3. Is enrolled in a study to evaluate a new drug
4. Unable or unwilling to provide informed consent
5. Is a vulnerable person as deemed unfit for the study by the Principal Investigator

Recruitment start date

15/05/2020

Recruitment end date

10/06/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

The Royal London Hospital
Barts Health NHS Trust Whitechapel Road Whitechapel
London
E1 1BB
United Kingdom

Sponsor information

Organisation

Abbott (Germany)

Sponsor details

Abbott Rapid Diagnostics Jena GmbH
Orlaweg 1
Jena
07743
Germany
+44 7792902244
camilla.forssten@abbott.com

Sponsor type

Industry

Website

http://www.abbott.com/

Funders

Funder type

Not defined

Funder name

Abbott Rapid Diagnostics Jena GmbH

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are not expected to be made available as consent has not been obtained for making de-identified participant data available under GDPR. The data will be clearly explained in a peer-reviewed publication.

Intention to publish date

17/07/2020

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

22/06/2020: Trial’s existence confirmed by HRA.