Trial Outcomes & Findings for Seroprevalence of SARS-Cov-2 Antibodies in Children (NCT NCT04347408)

Results Overview

• Mean antibody titres (IgG/Total antibody) to SARS-CoV-2 in plasma using ROCH/ABBOTT and DIASORIN assays

Recruitment status

COMPLETED

Target enrollment

1100 participants

Primary outcome timeframe

6 months

Results posted on

2023-12-07

Participant Flow

In total, 1042 potential participants were screened for inclusion, of whom 50 were excluded; 18 were outside the specified age range, 1 met specific exclusion criteria,16 declined consent and 15 did not undergo phlebotomy. In total 992 were enrolled.

Participant milestones

Participant milestones
Measure	Healthy Children Healthy children of healthcare workers between 2 and 15 years of age Covid-19 Antibody testing (IgG and IgM): Antibody testing for previous exposure to Covid-19
Overall Study STARTED	992
Overall Study COMPLETED	992
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	Healthy Children n=992 Participants Healthy children of healthcare workers between 2 and 15 years of age Covid-19 Antibody testing (IgG and IgM): Antibody testing for previous exposure to Covid-19
Age, Continuous	10.1 years n=992 Participants
Sex: Female, Male Female	483 Participants n=992 Participants
Sex: Female, Male Male	509 Participants n=992 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Healthy children of healthcare workers between 2 and 15 years of age

• Mean antibody titres (IgG/Total antibody) to SARS-CoV-2 in plasma using ROCH/ABBOTT and DIASORIN assays

Outcome measures

Outcome measures
Measure	Healthy Children n=992 Participants Healthy children of healthcare workers between 2 and 15 years of age Covid-19 Antibody testing (IgG and IgM): Antibody testing for previous exposure to Covid-19
Immunoglobulins (G and M) to SARS-Cov2 in Plasma Elecys Roche SARS-CoV-2 (Cut-Off-Index COI)	65.32 Titres Interval 43.24 to 87.4
Immunoglobulins (G and M) to SARS-Cov2 in Plasma Diasorin Liason SARS-CoV-2 IgM (arbitrary units A/U)	64.17 Titres Interval 37.99 to 90.36
Immunoglobulins (G and M) to SARS-Cov2 in Plasma Abbott SARS-CoV-2 IgG Assay (Index S/C)	4.86 Titres Interval 4.28 to 5.45

SECONDARY outcome

Timeframe: 6 months

Measure of cardiac function

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Cardiac Enzyme

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Cardiac enzyme

Outcome measures

Outcome data not reported

Adverse Events

All-cause Mortality, Serious and Other Adverse Events Were Not Monitored/Assessed.

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

Dr Thomas Waterfield

Queen's University Belfast

Phone: 028 9024 5133

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place