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

• Sponsor: Rabin Medical Center (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05564884
• Collaborator: (none)
• Enrollment: 58
• Location: 1
• Anticipated Duration (Months): 13.6
• Patients Per Site Per Month: 4.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19	Other: no intervantion

Detailed 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.

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 58 participants
• Observational Model: Other
• Time Perspective: Prospective
• 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
• Actual Study Start Date: Sep 12, 2021
• Actual Primary Completion Date: Feb 24, 2022
• Anticipated Study Completion Date: Nov 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Unvaccinated, Prior natural COVID-19 infection Unvaccinated, Prior natural COVID-19 infection	Other: no intervantion; no intervention
Vaccinated, No prior natural COVID-19 infection Vaccinated, No prior natural COVID-19 infection	Other: no intervantion; no intervention
Vaccinated, Prior natural COVID-19 infection Vaccinated, Prior natural COVID-19 infection	Other: no intervantion; no intervention

Outcome Measures

Primary Outcome Measures

1. neonatal anti-spike antibody levels [6 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Female

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Schneider Children's Medical Center	Petach Tikva		Israel

Sponsors and Collaborators

• Rabin Medical Center

Investigators

• Principal Investigator: Liat Ashkenazi-Hoffnung, Schneider children medical center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rabin Medical Center
• ClinicalTrials.gov Identifier: NCT05564884
• Other Study ID Numbers: RMC-0275-21
• First Posted: Oct 4, 2022
• Last Update Posted: Oct 4, 2022
• Last Verified: Sep 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: COVID-19

Study Results

No Results Posted as of Oct 4, 2022