Coronavirus Clinical Trial
Official title:
Evaluation of Novel Diagnostic Tests for 2019-nCOV
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.
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