Acute DiseaseCOVIDxNCT04326387
Evaluation of Novel Diagnostic Tests for COVID-19
An observational study of Acute Disease and Coronavirus, run by CCTU- Cancer Theme at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Acute Disease, Coronavirus, Respiratory Viral Infection
- What is being tested?
- SAMBA II (Diagnostic for the Real World), Public Health England Gold Standard and Cambridge Validated Viral Detection Method
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Apr 2020to 7 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Child, Adult, Older adult
Study population: All patients who meet current PHE hospital inpatient definition of possible case of COVID-19.
Who may be able to join
- 16 years or above
- 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)
Who cannot join
- Patients who have not had the standard PHE COVID-19 test applied
- Unwilling or unable to comply with research swab of nose \& throat or tracheal fluid
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Cambridge University Hospitals NHS Foundation Trust
Cambridge, Cambridgeshire, CB2 0QQ
Ravi K Gupta, PhD, 07500792984, rkg20@cam.ac.uk
Dami Collier, MBBS, 07888707113, d.collier@ucl.ac.uk
About this study
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.
- Conditions
- Acute Disease, Coronavirus, Respiratory Viral Infection
- Being tested
- SAMBA II (Diagnostic for the Real World), Public Health England Gold Standard, Cambridge Validated Viral Detection Method, Radiological Detection
- Keywords
- Coronavirus, COVID-19, nCOV-2019
- Medical subject headings
- Acute Disease, Coronavirus Infections, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAMBA II (Diagnostic for the Real World)Diagnostic test
Point of care Isothermal-PCR Viral RNA Amplication for virus detection
Public Health England Gold StandardDiagnostic test
Reverse Transcription PCR
Cambridge Validated Viral Detection MethodDiagnostic test
Reverse Transcription PCR
Radiological DetectionDiagnostic test
Also called Chest X-ray, CT Scan
Chest X-ray \& CT Scan detection of viral infection in the lungs
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
SAMBA COVID-19 POC PCR Test
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
Measured: 28 days
Secondary outcomes (2)
Patient acceptability
Evaluating the participant acceptability of the SAMBA swab intervention using a participant reported discomfort scale
Measured: 28 days
Immune Response Positivity
Time to positive IgM/IgG test positivity
Measured: 40 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2020
- Study start6 Apr 2020
- Primary completion7 Apr 2021 (estimated)
- Study completion7 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CCTU- Cancer Theme
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, CCTU- Cancer Theme, Cambridge University Hospitals NHS Foundation Trust
- Investigators
- Ravindra Prof. Gupta, BMBCh, Principal investigator, University of Cambridge & Cambridge University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04326387
- Sponsor's protocol ID
- COVIDx
- Acronym
- COVIDx
- Status last verified
- May 2020
- First submitted
- 26 Mar 2020
- Last updated
- 18 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Novel Diagnostic Tests for 2019-nCOV
- ClinicalTrials.gov ID
- NCT04326387
- Acronym / sponsor ID
- COVIDx / COVIDx
- Conditions
- Acute Disease, Coronavirus, Respiratory Viral Infection
- Keywords
- Coronavirus, COVID-19, nCOV-2019
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- CCTU- Cancer ThemeUniversity, hospital or other
- Study start
- 6 Apr 2020 (actual)
- Primary completion
- 7 Apr 2021 (estimated)
- Study completion
- 7 Oct 2021 (estimated)
- First posted
- 30 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Research Participants (Patients) | – | 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 DetectionInpatients 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 |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- All patients who meet current PHE hospital inpatient definition of possible case of COVID-19.
Key inclusion criteria (5 listed)
- 16 years or above
- 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)
Key exclusion criteria (2 listed)
- Patients who have not had the standard PHE COVID-19 test applied
- Unwilling or unable to comply with research swab of nose \& throat or tracheal fluid
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SAMBA II (Diagnostic for the Real World)Point of care Isothermal-PCR Viral RNA Amplication for virus detection | Diagnostic test | Research Participants (Patients) |
| Public Health England Gold StandardReverse Transcription PCR | Diagnostic test | Research Participants (Patients) |
| Cambridge Validated Viral Detection MethodReverse Transcription PCR | Diagnostic test | Research Participants (Patients) |
| Radiological DetectionAlso: Chest X-ray, CT ScanChest X-ray \& CT Scan detection of viral infection in the lungs | Diagnostic test | Research Participants (Patients) |
Primary outcome
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
2 secondary outcomes
Patient acceptability
Time frame: 28 days
Immune Response Positivity
Time frame: 40 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ravindra Prof. Gupta, BMBCh principal investigator
University of Cambridge & Cambridge University Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Disease and Coronavirus, run by CCTU- Cancer Theme at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Richard D. Skells, BSc. (01223 349707 ext. 349707, richard.skells@addenbrookes.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SAMBA COVID-19 POC PCR Test (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2020.