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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

CCTU Cancer 01223 216038
cctu.cancer@addenbrookes.nhs.uk


Richard D. Skells, BSc. 01223 349707
richard.skells@addenbrookes.nhs.uk


Study Location:

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Be Part of Research - Trial Details - Evaluation of Novel Diagnostic Tests for COVID-19

Evaluation of Novel Diagnostic Tests for COVID-19

Not Recruiting

Open to: ALL

Age: 16.0 - N/A

Medical Conditions

Acute Disease
Coronavirus
Respiratory Viral Infection


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


COVID-19 (also known as Coronavirus) originated in the Wuhan China and has since spread to at least 159 countries around the world. It was declared a pandemic by the World health organisation on the 11th of March 2020. The cases in the United Kingdom continue to increase exponentially with up to 5 683 people diagnosed as on the 22nd of March 2020. It is estimated that 1 in 5 people diagnosed will require hospital admission and 1 in 20 intensive care treatment. By developing and improving diagnostic testing, we can accurately diagnose infected cases to triage appropriate treatments, identify individuals for quarantine in order to prevent transmission and obtain information regarding patient's immune systems.

At present, the diagnostic test is a highly specific method of genetic amplification called 'Reverse Transcription - Polymerase Chain Reaction' or RT-PCR, which allows detection of very small amounts of genetic mutations caused by the COVID-19 virus. However, this method must be completed in highly specialised facilities, which are few and far between, increasing time to diagnosis (currently 48-72 hours), increasing exposure to non-infected individuals, and overburdening the analysing facilities. The ideal solution is a point of care (POC) test that can give results immediately. This study aims to harness the point of care technology of the SAMBA II device (Diagnostics for the Real World Ltd.), which is a CE-marked device that has been used with success in the identification of Human Immunodeficiency Virus (HIV), by amplifying genetic material without the need to increase and decrease temperatures during the amplification process.

In the COVIDx study, 200 patients meeting the Public Health England's (PHE) inpatient definition of having suspected COVID-19 will be approached, consented and a sample from throat and nasal swab (combined) or tracheal fluid taken and tested using the SAMBA II method. A combination of the standard PHE RT-PCR and an additional validated laboratory PCR technique will be used as a control in line with standard clinical practice. Patients will undergo an additional serum tests on existing samples as made available after routine clinical assessments to monitor antibody response. Patients will be followed for clinical outcomes at 28 days post-admission.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Apr 2020 Apr 2021

OBSERVATIONAL

Intervention Type : DIAGNOSTIC_TEST
Intervention Description : Point of care Isothermal-PCR Viral RNA Amplication for virus detection

Intervention Arm Group : Research Participants (Patients);

Intervention Type : DIAGNOSTIC_TEST
Intervention Description : Reverse Transcription PCR

Intervention Arm Group : Research Participants (Patients);

Intervention Type : DIAGNOSTIC_TEST
Intervention Description : Reverse Transcription PCR

Intervention Arm Group : Research Participants (Patients);

Intervention Type : DIAGNOSTIC_TEST
Intervention Description : Chest X-ray \& CT Scan detection of viral infection in the lungs

Intervention Arm Group : Research Participants (Patients);



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Cambridge University Hospitals NHS Foundation Trust
    Cambridge
    Cambridgeshire
    CB2 0QQ

Unfortunately, this study is not recruiting public volunteers at this time. This is because the research isn’t ready for volunteers yet or the researchers are directly identifying volunteers in certain areas or hospitals. Please do not contact the research team as they will not be able to respond. For more information about research in general, visit the Be Part of Research homepage.  


The study is sponsored by CCTU- Cancer Theme




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Read full details for Trial ID: NCT04326387
Last updated 15 May 2020

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