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Evaluation of Novel Diagnostic Tests for COVID-19 (COVIDx)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04326387
Recruitment Status : Recruiting
First Posted : March 30, 2020
Last Update Posted : May 18, 2020
Information provided by (Responsible Party):
CCTU- Cancer Theme, Cambridge University Hospitals NHS Foundation Trust

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.

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

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
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

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. Patient acceptability [ Time Frame: 28 days ]
    Evaluating the participant acceptability of the SAMBA swab intervention using a participant reported discomfort scale

  2. Immune Response Positivity [ Time Frame: 40 days ]
    Time to positive IgM/IgG test positivity

Biospecimen Retention:   Samples Without DNA
Throat/Nasal Swab, Nasopharyngeal Swab, Endotracheal tube aspirate and whole blood-serum for viral-RNA analysis

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
All patients who meet current PHE hospital inpatient definition of possible case of COVID-19.

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

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 identifier (NCT number): NCT04326387

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Contact: Richard D. Skells, BSc. 01223 349707 ext 349707
Contact: CCTU Cancer 01223 216038 ext 216083

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United Kingdom
Cambridge University Hospitals NHS Foundation Trust Recruiting
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
Contact: Ravi K Gupta, PhD    07500792984   
Contact: Dami Collier, MBBS    07888707113   
Principal Investigator: Ravi Gupta, PhD         
Sub-Investigator: Dami Collier, MBBS         
Sponsors and Collaborators
CCTU- Cancer Theme
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Principal Investigator: Ravindra Prof. Gupta, BMBCh University of Cambridge & Cambridge University Hospitals NHS Foundation Trust
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Responsible Party: CCTU- Cancer Theme, Prof. Ravindra Gupta, Cambridge University Hospitals NHS Foundation Trust Identifier: NCT04326387    
Other Study ID Numbers: COVIDx
First Posted: March 30, 2020    Key Record Dates
Last Update Posted: May 18, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CCTU- Cancer Theme, Cambridge University Hospitals NHS Foundation Trust:
Additional relevant MeSH terms:
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Coronavirus Infections
Virus Diseases
Acute Disease
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Disease Attributes
Pathologic Processes