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NCT05564884 Clinical Trial

Neonatal SARS-CoV-2 Anti-spike Protein Receptor-binding Domain Antibodies at Delivery

COVID-19 Clinical Trial

Official title:
The Association of Neonatal SARS-CoV-2 Anti-spike Protein Receptor-binding Domain Antibodies at Delivery With Infant COVID-19 Infection Under Age 6 Months: a Prospective Cohort Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05564884
Other study ID # RMC-0275-21
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date September 12, 2021
Est. completion date November 1, 2022

Study information
Verified date September 2022
Source Rabin Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

Description:

This prospective observational study was conducted at the Rabin Medical Center, Israel. Mothers were enrolled from September 2021 to mid-February 2022, prior to transfer to the delivery room, and followed at the Maternity and Infant Ward. The study was approved by the institutional ethics committee (RMC- 0275-21). Written informed consent was obtained from the participating mothers. Inclusion criteria included maternal recipient of at least one dose of the BNT162b2 mRNA COVID-19 vaccine or prior microbiologically-confirmed natural COVID-19 infection. Exclusion criteria included (a) preterm birth at <34 weeks gestation; (b) congenital or acquired immune deficiency, including recipient of biological agents during the prior year to enrolment.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 58
Est. completion date November 1, 2022
Est. primary completion date February 24, 2022
Accepts healthy volunteers
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria: included maternal recipient of at least one dose of the BNT162b2 mRNA COVID-19 vaccine or prior microbiologically-confirmed natural COVID-19 infection Exclusion Criteria: (a) preterm birth at <34 weeks gestation; (b) congenital or acquired immune deficiency, including recipient of biological agents during the prior year to enrolment.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• no intervantion
no intervention

Locations
Country Name City State
Israel Schneider Children's Medical Center Petach Tikva

Sponsors (1)
Lead Sponsor Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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