The Impact of COVID-19 on Maternal and Neonatal Outcomes

COVID-19 Clinical Trial

Official title:

The Impact of COVID-19 on Maternal and Neonatal Outcomes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05197621
• Other study ID #: IRB00246472
• Status: Recruiting
• Start date: April 13, 2020
• Est. completion date: May 5, 2026

Study information

• Verified date: May 2024
• Source: Johns Hopkins University
• Contact: William C Golden, MD
• Phone: 410-955-4588
• Email: cgolden[@]jhmi.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The novel coronavirus (SARS-CoV-2) infection (COVID-19) has caused a worldwide pandemic. There is still much that is unknown regarding the virus, especially its effects on pregnancy, the fetus, and the neonate. This study seeks to evaluate adverse pregnancy and neonatal outcomes related to COVID-19 infection. The FDA has authorized emergency use authorization for the SARS-CoV-2 messenger ribonucleic acid (mRNA) vaccines from Pfizer and Moderna. Pregnant women were excluded from the Phase III clinical trials of the mRNA vaccines. There are no studies that have evaluated functional antibody responses, antibody reactivity to variant viruses, T cell frequencies or activity, or protection against infection or development of COVID-19. Having a more detailed understanding of how pregnancy and lactation alters the longevity, specificity, and activity of antiviral antibody and T cell-mediated immune responses to COVID-19 mRNA vaccines is essential for the FDA to inform future recommendations and regulation of these vaccines.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: May 5, 2026
• Est. primary completion date: May 5, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 14 Years to 55 Years

Eligibility

Inclusion Criteria for Vaccine Arm:

• All pregnant women receiving their prenatal care from the Johns Hopkins Hospital or Johns Hopkins Bayview Medical Center, who are planning to receive an mRNA COVID vaccine and/or a third dose booster during their pregnancy.

Exclusion Criteria:

• Prior COVID-19 infection.

Inclusion Criteria for Sample Collection Arm:

• All pregnant women admitted to the Johns Hopkins Hospital or Johns Hopkins Bayview Medical Center for delivery and their newborn (at birth), will be considered for enrollment.
• Pregnant patients with a positive COVID-19 test during their pregnancy or at the time of admission to Labor & Delivery.

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• COVID-19
• Pregnancy Complications, Infectious

Intervention

Biological:
• mRNA COVID-19 vaccine (Pfizer or Moderna)
mRNA vaccine received at any time during pregnancy course

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	Integrated Research Center for Fetal Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of biospecimens from recently delivered pregnant women and neonates who were diagnosed with COVID-19 during their pregnancy	Evaluation of biospecimens (maternal & neonatal blood, cord blood, placenta samples, neonatal stool samples & breast milk) collected from recently delivered pregnant women and neonates for biomarkers of placental inflammation and early onset neonatal sepsis.	Testing will be performed from the time of study enrollment up to one year after sample collection
Secondary	To evaluate the immunogenicity of COVID-19 mRNA vaccines in pregnant and lactating people	Investigation of antibody responses to COVID-19 mRNA vaccination in pregnant and lactating people over the course of one-year post vaccination (from both initial vaccine and booster administrations).	Testing will be performed from the time of study enrollment up to one year after sample collection
Secondary	To evaluate the immunogenicity of COVID-19 mRNA vaccines in pregnant and lactating people	Identification of T cell responses to COVID-19 mRNA vaccination in pregnant and lactating people over the course of one-year post vaccination (from both initial vaccine and booster administrations).	Testing will be performed from the time of study enrollment up to one year after sample collection
Secondary	To evaluate the efficacy of COVID-19 mRNA vaccines in pregnant and lactating people	Determination of SARS-CoV-2 vaccine efficacy and characterization of breakthrough infections with SARS-CoV-2 variants that evaded vaccine induced immunity.	Testing will be performed from the time of study enrollment up to one year after sample collection