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

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.

Study Overview

• Status: Unknown
• Conditions: Acute Disease; Coronavirus; Respiratory Viral Infection
• Intervention / Treatment: 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
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Richard D. Skells, BSc.; Phone Number: 349707 01223 349707; Email: richard.skells@addenbrookes.nhs.uk
• Study Contact Backup: Name: CCTU Cancer; Phone Number: 216083 01223 216038; Email: cctu.cancer@addenbrookes.nhs.uk

Study Locations

• United Kingdom
  • Cambridgeshire
    • Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
      • Recruiting
      • Cambridge University Hospitals NHS Foundation Trust
      • Contact: Ravi K Gupta, PhD; Phone Number: 07500792984; Email: rkg20@cam.ac.uk
      • Contact: Dami Collier, MBBS; Phone Number: 07888707113; Email: d.collier@ucl.ac.uk
      • Principal Investigator: Ravi Gupta, PhD
      • Sub-Investigator: Dami Collier, MBBS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: N/A
• Genders 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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 Names: Chest X-ray, CT Scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient acceptability	Evaluating the participant acceptability of the SAMBA swab intervention using a participant reported discomfort scale	28 days
Immune Response Positivity	Time to positive IgM/IgG test positivity	40 days

Collaborators and Investigators

• Sponsor: CCTU- Cancer Theme
• Investigators: Principal Investigator: Ravindra Prof. Gupta, BMBCh, University of Cambridge & Cambridge University Hospitals NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 6, 2020
• Primary Completion (ANTICIPATED): April 7, 2021
• Study Completion (ANTICIPATED): October 7, 2021

Study Registration Dates

• First Submitted: March 26, 2020
• First Submitted That Met QC Criteria: March 27, 2020
• First Posted (ACTUAL): March 30, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 18, 2020
• Last Update Submitted That Met QC Criteria: May 15, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Coronavirus; COVID-19; nCOV-2019
• Additional Relevant MeSH Terms: Pathologic Processes; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Infections; Disease Attributes; Coronavirus Infections; Virus Diseases; Acute Disease
• Other Study ID Numbers: COVIDx

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No