NCT05564884

Brief Summary

To assess the association between neonatal SARS-CoV-2 antibody level at delivery and infant COVID-19 infection under age 6 months, and to identify predictive factors for neonatal antibody level at delivery.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
58

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 12, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 24, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 29, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 4, 2022

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

October 4, 2022

Status Verified

September 1, 2022

Enrollment Period

6 months

First QC Date

September 29, 2022

Last Update Submit

September 29, 2022

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

  • neonatal anti-spike antibody levels

    Primary outcomes were neonatal anti-spike antibody levels at delivery and infant microbiologically-confirmed COVID-19 infection at age \<6 months

    6 months

Study Arms (3)

Unvaccinated, Prior natural COVID-19 infection

Unvaccinated, Prior natural COVID-19 infection

Other: no intervantion

Vaccinated, No prior natural COVID-19 infection

Vaccinated, No prior natural COVID-19 infection

Other: no intervantion

Vaccinated, Prior natural COVID-19 infection

Vaccinated, Prior natural COVID-19 infection

Other: no intervantion

Interventions

no intervantionOTHER

no intervention

Unvaccinated, Prior natural COVID-19 infectionVaccinated, No prior natural COVID-19 infectionVaccinated, Prior natural COVID-19 infection

Eligibility Criteria

Sexfemale
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Mothers prior to transfer to the delivery room and followed at the Maternity and Infant Ward

You may qualify if:

  • included maternal recipient of at least one dose of the BNT162b2 mRNA COVID-19 vaccine or prior microbiologically-confirmed natural COVID-19 infection

You may not qualify if:

  • (a) preterm birth at \<34 weeks gestation; (b) congenital or acquired immune deficiency, including recipient of biological agents during the prior year to enrolment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Schneider Children's Medical Center

Petah Tikva, Israel

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Liat Ashkenazi-Hoffnung

    Schneider children medical center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2022

First Posted

October 4, 2022

Study Start

September 12, 2021

Primary Completion

February 24, 2022

Study Completion

November 1, 2022

Last Updated

October 4, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

According to ethics committee approval.

Locations

IL(1)