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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04629157
Recruitment Status : Completed
First Posted : November 16, 2020
Last Update Posted : August 3, 2021
Sponsor:
Information provided by (Responsible Party):
Alder Hey Children's NHS Foundation Trust

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.

Condition or disease Intervention/treatment Phase
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 Device: Innova Lateral Flow Device Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 185 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Paired testing
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The LAVA (Lateral Flow Antigen Validation and Applicability) Study for COVID-19
Actual Study Start Date : November 5, 2020
Actual Primary Completion Date : February 1, 2021
Actual Study Completion Date : February 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: All patients
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
The Innova Lateral Flow Device will be used on anterior nasal swab specimens and RT-PCR will be performed on nose and throat swabs.




Primary Outcome Measures :
  1. Acceptability of test [ Time Frame: Immediately after 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


Secondary Outcome Measures :
  1. Test failure rate [ Time Frame: 2 weeks ]
    A description of the test failure rate of lateral flow devices compared to RT-PCR will be performed.


Other Outcome Measures:
  1. Comparison of the results of lateral flow device to RT-PCR [ Time Frame: 2 weeks ]
    These data will be used to inform power calculations to determine the number of patients required to determine the validity of the tests



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Children aged 0 - <18 years undergoing combined nose and throat swabbing for an elective diagnostic or surgical procedure.
  2. Children aged 0 - <18 years undergoing combined nose and throat swabbing on admission to hospital when there is a differential diagnosis of COVID-19.
  3. 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.

Exclusion Criteria:

None


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 ClinicalTrials.gov identifier (NCT number): NCT04629157


Locations
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United Kingdom
Alder Hey in the Park
Liverpool, United Kingdom
Royal Manchester Children's Hospital
Manchester, United Kingdom
Sponsors and Collaborators
Alder Hey Children's NHS Foundation Trust
  Study Documents (Full-Text)

Documents provided by Alder Hey Children's NHS Foundation Trust:
Informed Consent Form  [PDF] October 15, 2020

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Responsible Party: Alder Hey Children's NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT04629157    
Other Study ID Numbers: 290989
First Posted: November 16, 2020    Key Record Dates
Last Update Posted: August 3, 2021
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will not be shared outside of the research team

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases