Evaluation of Novel Diagnostic Tests for COVID-19
COVIDx
1 other identifier
observational
200
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2020
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 26, 2020
CompletedFirst Posted
Study publicly available on registry
March 30, 2020
CompletedStudy Start
First participant enrolled
April 6, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 7, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 7, 2021
CompletedMay 18, 2020
May 1, 2020
1 year
March 26, 2020
May 15, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
28 days
Secondary Outcomes (2)
Patient acceptability
28 days
Immune Response Positivity
40 days
Study Arms (1)
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
Interventions
Point of care Isothermal-PCR Viral RNA Amplication for virus detection
Reverse Transcription PCR
Reverse Transcription PCR
Chest X-ray \& CT Scan detection of viral infection in the lungs
Eligibility Criteria
All patients who meet current PHE hospital inpatient definition of possible case of COVID-19.
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cambridge University Hospitals NHS Foundation Trust
Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom
Biospecimen
Throat/Nasal Swab, Nasopharyngeal Swab, Endotracheal tube aspirate and whole blood-serum for viral-RNA analysis
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ravindra Prof. Gupta, BMBCh
University of Cambridge & Cambridge University Hospitals NHS Foundation Trust
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Prof. Ravindra Gupta
Study Record Dates
First Submitted
March 26, 2020
First Posted
March 30, 2020
Study Start
April 6, 2020
Primary Completion
April 7, 2021
Study Completion
October 7, 2021
Last Updated
May 18, 2020
Record last verified: 2020-05