Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
200 participants
OBSERVATIONAL
2020-04-06
2021-10-07
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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
SAMBA II (Diagnostic for the Real World)
Point of care Isothermal-PCR Viral RNA Amplication for virus detection
Public Health England Gold Standard
Reverse Transcription PCR
Cambridge Validated Viral Detection Method
Reverse Transcription PCR
Radiological Detection
Chest X-ray \& CT Scan detection of viral infection in the lungs
Interventions
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SAMBA II (Diagnostic for the Real World)
Point of care Isothermal-PCR Viral RNA Amplication for virus detection
Public Health England Gold Standard
Reverse Transcription PCR
Cambridge Validated Viral Detection Method
Reverse Transcription PCR
Radiological Detection
Chest X-ray \& CT Scan detection of viral infection in the lungs
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient requiring hospital admission AND AT LEAST ONE OF
* Clinical or Radiological evidence of pneumonia
* Acute respiratory distress syndrome
* Influenza like illness (defined as fever \>37.8oC and at least one of the following respiratory symptoms, which much be of acute onset: persistent cough (with or without sputum), hoarseness, nasal discharge or congestion, shortness of breath, sore throat, wheezing, sneezing)
Exclusion Criteria
* Unwilling or unable to comply with research swab of nose \& throat or tracheal fluid
16 Years
ALL
No
Sponsors
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CCTU- Cancer Theme
OTHER
Responsible Party
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CCTU- Cancer Theme
Prof. Ravindra Gupta
Principal Investigators
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Ravindra Prof. Gupta, BMBCh
Role: PRINCIPAL_INVESTIGATOR
University of Cambridge & Cambridge University Hospitals NHS Foundation Trust
Locations
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Cambridge University Hospitals NHS Foundation Trust
Cambridge, Cambridgeshire, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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COVIDx
Identifier Type: -
Identifier Source: org_study_id
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