Clinical Evaluation of Rapid RNA Test for Covid-19

NCT05308550 | Completed

• 2 other identifiers: 56505283408
• Study Type: interventional
• Target: 369
• Locations: 1 country
• Sites: 1

Brief Summary

A new Rapid RNA test for Covid-19 has been developed by Professor Cui and his team at the Department of Engineering Science at the University of Oxford. This can give results in 30 minutes which is much faster than the routine PCR test, which often takes 2-3 days to produce results. In this study we aim to establish the sensitivity of the rapid RNA test, which has never before been evaluated clinically. Preliminary anecdotal evidence suggests that the test is easy to use and appears to give valid results. This initial trial aims to establish whether the sensitivity of this tests is above the threshold of 90%. We aim to include at least 173 patients with symptoms of Covid-19 in Watford General Hospital.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Sensitivity and specificity compared to standard PCR

  Test swab taken within 12 hours of the standard PCR swab

  within 12 hours

Study Arms (2)

Phase 1

OTHER

Version 1 of the rapid test: The clinician taking the nasopharyngeal / oropharyngeal swab for standard PCR testing for Covid-19 collected a second swab directly afterwards for the rapid RNA test. The swab was placed in a dry tube, labelled with the patient's ID, date and time of taking the sample, and was taken to the microbiology laboratory for processing. In the laboratory, 2ml of RNase-free water was added to the tube and shaken with the swab. Twenty-five microlitres of the swab solution was transferred into a PCR tube containing the dried reagents for the rapid RNA test. This tube was then incubated for 45 minutes at 65'C, then taken out to cool down. The colour of the tube was recorded by the laboratory technician.

Diagnostic Test: rapid RT-LAMP test to detect SARS-COV-2 RNA

Phase 2

OTHER

Version 2 of the rapid test: The clinician taking the nasopharyngeal / oropharyngeal swab for standard PCR testing for Covid-19 collected a second swab directly afterwards for the rapid RNA test. The swab was placed in a tube containing 1ml of normal saline (instead of a dry tube). If the patient was eligible but the standard swab had already been taken \>12 hours before, we asked them for their consent to take a second standard swab alongside the swab for the rapid RNA test, to ensure that the samples were comparable. In the laboratory, the swab was heated to 95'C for 5 minutes to inactivate the virus. Nine ml of RNase-free water was added to the tube and shaken with the swab, before transferring 25ul of the swab solution into the PCR tube containing the dried reagents. This tube was then incubated for 30 minutes at 65'C, then the colour of the tube was recorded and photographed by the laboratory technician at 30 minutes (primary reading) and 45 minutes (secondary reading).

Diagnostic Test: rapid RT-LAMP test to detect SARS-COV-2 RNA

Interventions

rapid RT-LAMP test to detect SARS-COV-2 RNA DIAGNOSTIC_TEST

rapid RT-LAMP test to detect SARS-COV-2 RNA

Phase 1; Phase 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients presenting to hospital with symptoms of Covid-19 OR who are asymptomatic but being screened for Covid-19 (including in hospital and drive-through testing centres)
• Age 18 or over
• Swab is being taken for standard PCR test of Covid-19
• Willing and able to give written informed consent

You may not qualify if:

• Lack of written consent
• Age under 18
• Routine PCR test not being conducted

Sponsors & Collaborators

• University of Southampton: lead
• West Hertfordshire Hospitals NHS Trust: collaborator
• University of Oxford: collaborator

Study Sites (1)

Watford General Hospital

Watford, Hertfordshire, WD18 0HB, United Kingdom

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Michael Moore, FRCGP

  University of Southampton

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two cohorts, the second with a modified version of the test.

Study Record Dates

• First Submitted: March 25, 2022
• First Posted: April 4, 2022
• Study Start: May 27, 2020
• Primary Completion: February 27, 2021
• Study Completion: February 27, 2021
• Last Updated: April 4, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)