Evaluation of COVID-19 IgG Antibodies in Maternal and Cord Blood Samples

NCT04732767 | Withdrawn

• 1 other identifier: 08-20-20E
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Protocol Summary Study design: Prospective cohort study of pregnant COVID-19 positive patients at delivery. Study Objective: To collect umbilical cord blood and placenta samples at the time of delivery in COVID-19 positive women and evaluate for presence of COVID-19 virus and maternal antibody response. Inclusion/Exclusion Criteria: Women admitted for delivery who are known or suspected COVID-19 positive who have had standard nasal swab testing for COVID-19. Study Procedures: Informed consent for patients will be obtained. Maternal blood will be collected for viral and antibody tests for COVID-19. Following delivery of the neonate, cord blood and placenta samples will be collected and sent for viral PCR and maternal antibody analysis. Neonatal testing will be done as per existing clinical protocol for infants born to PUI/COVID-19 positive women. Statistical Analysis: Statistical analysis for this study will include descriptive analysis and quantitative statistics of findings.

Conditions

Covid19; Pregnancy Related; Antibody Response

Outcome Measures

Primary Outcomes (1)

• Presence of COVID-19 IgG antibodies by immunoassay in maternal and cord blood samples.

  Immunoassay will be used to detect qualitative levels of COVID-19 IgG antibodies in maternal and cord blood.

  6 months

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: pregnant
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant patients at greater than age 18 who have had a positive COVID-19 PCR test during pregnancy

You may qualify if:

• \- Women admitted for delivery who are known or suspected COVID-19 positive and women were positive at any time during pregnancy who have had standard nasal swab PCR testing for COVID-19.

You may not qualify if:

• \- Patients less than 18 years of age. Patients unable to give consent. Patients who are immunocompromised.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Biospecimen

Retention: SAMPLES WITH DNA

Samples obtained during the study will include maternal and cord blood samples. These samples will be stored for potential future studies.

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Ngina K Connors, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2021
• First Posted: February 1, 2021
• Study Start: January 20, 2021
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: April 25, 2022

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share