CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 400 enrolled
Drug / intervention
Innova Lateral Flow Devicedevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04629157
NCT04629157N/ACompleted

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

Alder Hey Children's NHS Foundation Trust·interventional·Posted Nov 16, 2020·Updated Nov 13, 2024

In Brief

A clinical study evaluating Innova Lateral Flow Device for 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 and Covid19. Completed, enrolled 400 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedNov 16, 2020
Enrollment StartNov 5, 2020
Primary CompletionFeb 1, 2021
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 5.6 years ago

Interventions

Innova Lateral Flow Devicedevice

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