Evaluation of Novel Diagnostic Tests for COVID-19 (COVIDx)
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|ClinicalTrials.gov Identifier: NCT04326387|
Recruitment Status : Recruiting
First Posted : March 30, 2020
Last Update Posted : May 18, 2020
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.
|Condition or disease||Intervention/treatment|
|Acute Disease Coronavirus Respiratory Viral Infection||Diagnostic Test: SAMBA II (Diagnostic for the Real World) Diagnostic Test: Public Health England Gold Standard Diagnostic Test: Cambridge Validated Viral Detection Method Diagnostic Test: Radiological Detection|
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Evaluation of Novel Diagnostic Tests for 2019-nCOV|
|Actual Study Start Date :||April 6, 2020|
|Estimated Primary Completion Date :||April 7, 2021|
|Estimated Study Completion Date :||October 7, 2021|
Research Participants (Patients)
Inpatients symptomatic of suspected COVID-19 Baseline swab of nose/throat, nasopharyx, or endotracheal tube aspirate. SAMBA II point of care test on this swab.
Standard of care bloods taken for PHE and additional confirmatory diagnostic PCR assessment.
Serum antibody tests on any excess blood tests during inpatient stay for immune response monitoring.
Outcome assessment at 1 month
Diagnostic Test: SAMBA II (Diagnostic for the Real World)
Point of care Isothermal-PCR Viral RNA Amplication for virus detection
Diagnostic Test: Public Health England Gold Standard
Reverse Transcription PCR
Diagnostic Test: Cambridge Validated Viral Detection Method
Reverse Transcription PCR
Diagnostic Test: Radiological Detection
Chest X-ray & CT Scan detection of viral infection in the lungs
Other Name: Chest X-ray, CT Scan
- SAMBA COVID-19 POC PCR Test [ Time Frame: 28 days ]Measuring the diagnostic accuracy of the SAMBA II POC-sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) tested against a dual composite reference standard
- Patient acceptability [ Time Frame: 28 days ]Evaluating the participant acceptability of the SAMBA swab intervention using a participant reported discomfort scale
- Immune Response Positivity [ Time Frame: 40 days ]Time to positive IgM/IgG test positivity
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04326387
|Contact: Richard D. Skells, BSc.||01223 349707 ext firstname.lastname@example.org|
|Contact: CCTU Cancer||01223 216038 ext email@example.com|
|Cambridge University Hospitals NHS Foundation Trust||Recruiting|
|Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ|
|Contact: Ravi K Gupta, PhD 07500792984 firstname.lastname@example.org|
|Contact: Dami Collier, MBBS 07888707113 email@example.com|
|Principal Investigator: Ravi Gupta, PhD|
|Sub-Investigator: Dami Collier, MBBS|
|Principal Investigator:||Ravindra Prof. Gupta, BMBCh||University of Cambridge & Cambridge University Hospitals NHS Foundation Trust|