Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05614427 |
| Other study ID # |
292509 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 26, 2021 |
| Est. completion date |
April 20, 2022 |
Study information
| Verified date |
November 2022 |
| Source |
Alder Hey Children's NHS Foundation Trust |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The Lateral Flow Antigen Validity and Applicability (LAVA) 2 study aims to determine the
validity of lateral flow antigen devices (LFDs) used to perform point of care testing for
COVID-19, compared to the current gold standard test of RTPCR in children. In a pilot study
we have shown that the anterior nose swabs used to perform a LFD test are associated with
significantly lower pain scores than the nose and throat swabs used to perform RT-PCR tests
and that the results are available significantly more quickly. RT-PCR is an excellent
diagnostic test but one drawback includes remaining positive for a prolonged period,
potentially when the person is no longer infective, as it can pick up viral particulate
rather than live virus. LFDs are more likely to be positive at the point that a person has a
high viral load and is therefore infectious to others, but this has not been studied in
non-laboratory settings in children. The study aims to determine the correlation between LFD
and viral load detected on RT-PCR in children to enable the utility of the test in different
clinical and non-clinical settings to be better determined.
Description:
Purpose and Design This study aims to answer key questions about testing for COVID-19 in
children. COVID-19 in children is very different from adults: COVID-19 infection is less
prevalent in children compared to adults and the disease course is very much milder, with
children being more likely to be asymptomatic than adults. Currently, all children admitted
to hospital or undergoing a procedure under general anaesthetic are routinely tested for
SARS-CoV-2 using RT-PCR performed on a nose and throat swab. Whilst this is an excellent
diagnostic test for someone who is symptomatic with COVID-19, it can remain positive for a
significant period after a person has been infected with COVID-19 and is no longer a risk to
others. In a clinical setting this can result in elective operations being cancelled,
potentially unnecessarily. Additionally, it means that children who may be infective with
COVID-19 are less likely to be symptomatic with the infection, indeed many patients who have
been diagnosed with COVID-19 have been admitted to hospital for an unrelated cause, making
differentiation on the basis of symptoms difficult. We have chosen to look primarily at the
relationship between lateral flow device tests performed on anterior nasal swabs, which are a
less painful swab and give a rapid result, compared to the viral load detected using RT-PCR
performed on a nose and throat swab. This will complement ongoing work which is being
performed outside of the group proposing this study, which is examining the relationship
between viral load and infectivity. This study will be able to determine the performance of
the LFD at different viral loads and therefore the utility of the LFD within clinical
settings to predict which patients are infective with SARS-CoV-2.
The study has been designed by a multidisciplinary team, described in the steering group.
Unfortunately due to the need to deliver this study rapidly, patient and parental input has
not been specifically sought but the pain scores described in the pilot study work display
the acceptability of this test to parents.
Recruitment and consent In order to recruit a sufficient number of patients to answer the
study question in a timely way, as is required, we have built into the protocol the option to
take deferred consent to participate in the study. The acceptability of the swabs is clear
within the pilot study and the test is being widely used in community settings already.
Deferred consent is not felt to be appropriate for children in the peri-operative period due
to the impact that it may have on their clinical care and therefore patients and families
will be approached about the study before the swab is performed. In all other settings, a
routine swab for SARS-CoV-2 is being performed anyway which is more painful for the child
than the study swab.
The specificity of the LFD has been shown to be very good (99.6%) in laboratory and clinical
settings and therefore employing the use of the LFD within the study may also enable
hospitals to detect asymptomatic infective children with COVID-19 earlier in their admission.
A recording of the patients who are approached before a routine swab is performed but who
decline the test will be kept to ensure that a swab is not performed anyway with the
assumption that they will be approached for deferred consent. The record will include the
child's hospital number and the parent's email address. No additional details will be held.
Patients will be approached for consent by being emailed a small amount of information about
the study with a link to the PIS followed by a link to the consent form, with the option to
record refusal of consent if they do not wish to participate. The appropriate PISC will be
sent according to whether they are approached before or after the anterior nose swab has been
taken. The person emailing the patients the PISC does not have to be GMP trained, but should
a patient or their family wish to ask questions they will have the details of the study
team's telephone number and email address. Inclusion/exclusion This study is intended to
include all children under 18 years of age who are undergoing routine swabbing or who are
having a procedure performed under general anaesthetic. Risks, burdens and benefits Having
undertaken the pilot study we have had opportunity to understand the impact on patients and
their families.
Many patients and parents were positive about participating in the study, appreciating the
opportunity to have an additional test prior to an operation and getting the results of the
LFD test back more quickly. As shown in the pilot study, the pain scores given by children
and parents were significantly lower using anterior nasal swabs compared to nose and throat
swabs suggesting that there is much higher acceptability of the test. Some participants did
refuse to participate because they were concerned that their child may find an additional
swab distressing or because they did not want to run the risk of a long-awaited elective
procedure being cancelled. During the pilot study we found no adverse events associated with
the anterior nasal swabs and given the lower pain scores seen, can reassure parents that the
swab required for the LFD is significantly less painful for a child. Confidentiality We are
collecting the hospital number of each patient to enable accurate tracking of patients within
the study. These will be visible to the central study team but each site's patients will only
be visible to patients within that site. The first half of the postcode is being collected
because subsequent analysis of the positive predictive value of the test requires the
prevalence of COVID-19 to be known. The DOB and sex of the child is being collected so that
the demographics of the patients included in the study are known, enabling appropriate
conclusions to be drawn. CAG approval has not been sought as the COPI notice issued by the
Secretary of State allows the appropriate collection of data within studies focussed on
COVID-19 to be collected and can include people who do not sit within the direct care team to
contribute to the recruitment and running of the study. Conflict of interest None of the
study group have any declared conflict of interest in the study. The results will be given to
Public Health England and will be submitted for peer review and subsequent publication.
