The LAVA (Lateral Flow Antigen Validation and Applicability) Study for COVID-19

NCT04629157 | Completed Results

• 1 other identifier: 290989
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 2

Brief Summary

This is a pilot study which aims to assess the validity and applicability of lateral flow assays (LFAs) which can be used as a point of care test for COVID-19. The study will focus on children admitted to hospital or planned to have a procedure for which they require an anaesthetic. RT-PCR is the current gold standard test for COVID-19, but it usually takes approximately 24-48 hours for a test result to be returned which can slow the clinical care given to a patient and can potentially increase the risk of healthcare worker (HWC) exposure to COVID-19. LFAs are a point of care test which can identify children who have a high viral load of COVID-19 and are performed using a more acceptable method of swabbing for children, just inside the nostril. Using LFA potentially enables the identification of infectious children with COVID-19 to aid with immediate care of patients and limiting HWC and other patients' contact with the virus. This study aims to assess the test failure rate and identify reasons for this which can be addressed. It also aims to assess the discomfort of both tests for children, provide a comparison between the time to LCA and RT-PCR result and provide data for a trial to adequately power a prospective trial comparing RT-PCR and LFA.

Conditions

This is a Pilot Study Which Aims to Assess the Validity and Applicability of Lateral Flow Assays (LFAs) Which Can be Used as a Point of Care Test for COVID-19; Covid19

Outcome Measures

Primary Outcomes (1)

• Acceptability of Test

  A pain score (Wong-Baker) will be used to assess the pain of performing an anterior nasal swab and a nose and throat swab. This is a visual analog score accompanied by facial expressions from a scale of 0 to 10 where 0 is no pain and 10 is severe pain. The score is given by a child if they are old enough to do this, or by their parents if they are not, immediately after the swab has been performed.

  Immediately after test on the day of test

Study Arms (1)

All patients

EXPERIMENTAL

All patients entering the study will undergo paired testing of a lateral flow device using an anterior nasal swab and an RT-PCR using a nose and throat swab.

Device: Innova Lateral Flow Device

Interventions

Innova Lateral Flow Device DEVICE

The Innova Lateral Flow Device will be used on anterior nasal swab specimens and RT-PCR will be performed on nose and throat swabs.

All patients

Eligibility Criteria

• Age: 0 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 0 - \<18 years undergoing combined nose and throat swabbing for an elective diagnostic or surgical procedure.
• Children aged 0 - \<18 years undergoing combined nose and throat swabbing on admission to hospital when there is a differential diagnosis of COVID-19.
• Children aged 0 - \<18 years undergoing routine combined nose and throat swabbing during a stay on the intensive care unit, the high dependency unit or a transplant ward.

You may not qualify if:

• None

Sponsors & Collaborators

• Alder Hey Children's NHS Foundation Trust: lead

Study Sites (2)

Alder Hey in the Park

Liverpool, United Kingdom

Location

Royal Manchester Children's Hospital

Manchester, United Kingdom

Location

Related Publications (1)

• Harwood R, Rad L, Kelly C, Shelton C, Shepherd E, Roderick M, Whittaker E, Dyke S, Patel SV, Gent N, Kenny SE. Lateral flow test performance in children for SARS-CoV-2 using anterior nasal and buccal swabbing: sensitivity, specificity, negative and positive predictive values. Arch Dis Child. 2023 Feb;108(2):137-140. doi: 10.1136/archdischild-2022-324353. Epub 2022 Sep 9.

  PMID: 36657801 DERIVED

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

Results Point of Contact

• Title: Miss Rachel Harwood
• Organization: Alder Hey Children's NHS Foundation Trust

rachel.harwood@alderhey.nhs.uk

0151 228 4811

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Paired testing

Study Record Dates

• First Submitted: November 4, 2020
• First Posted: November 16, 2020
• Study Start: November 5, 2020
• Primary Completion: February 1, 2021
• Study Completion: February 1, 2021
• Last Updated: November 13, 2024
• Results First Posted: November 13, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)