Trial Outcomes & Findings for The LAVA (Lateral Flow Antigen Validation and Applicability) Study for COVID-19 (NCT NCT04629157)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

400 participants

Primary outcome timeframe

Immediately after test on the day of test

Results posted on

2024-11-13

Participant Flow

Participant milestones

Participant milestones
Measure	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. 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.
Overall Study STARTED	322
Overall Study COMPLETED	322
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Patients n=276 Participants 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. 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.
Age, Categorical <=18 years	276 Participants n=276 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=276 Participants
Age, Categorical >=65 years	0 Participants n=276 Participants
Age, Continuous	7.7 years STANDARD_DEVIATION 5.2 • n=276 Participants
Sex: Female, Male Female	135 Participants n=276 Participants
Sex: Female, Male Male	141 Participants n=276 Participants
Region of Enrollment United Kingdom	276 Participants n=276 Participants

PRIMARY outcome

Timeframe: Immediately after test on the day of test

Population: Children with a mean age of 7.7 years (std dev 5.2 years) were included.

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.

Outcome measures

Outcome measures
Measure	All Patients n=276 Participants 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. 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.
Acceptability of Test Anterior nasal swab - parental report	0 units on a scale Interval 0.0 to 2.0
Acceptability of Test Anterior nasal swab - child report	0 units on a scale Interval 0.0 to 2.0
Acceptability of Test Nose and throat swab - parent report	6 units on a scale Interval 4.0 to 8.0
Acceptability of Test Nose and throat swab - child report	4 units on a scale Interval 2.0 to 8.0

Adverse Events

All Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Miss Rachel Harwood

Alder Hey Children's NHS Foundation Trust

Phone: 0151 228 4811

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place