Clinical trial NCT05197621: The Impact of COVID-19 on Maternal and Neonatal Outcomes
Official title: The Impact of COVID-19 on Maternal and Neonatal Outcomes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: COVID-19
Pregnancy; Infection
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Integrated Research Center for Fetal Medicine
First posted: 2022-01-19
Enrollment: 300
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All pregnant women, aged 14-55, receiving prenatal care from 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, or, patients who have had a positive COVID-19 test during their pregnancy or at the time of admission to Labor \& Delivery.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of biospecimens from recently delivered pregnant women and neonates who were diagnosed with COVID-19 during their pregnancy
timeFrame: Testing will be performed from the time of study enrollment up to one year after sample collection
Secondary outcomes:
measure: To evaluate the immunogenicity of COVID-19 mRNA vaccines in pregnant and lactating people
timeFrame: Testing will be performed from the time of study enrollment up to one year after sample collection
measure: To evaluate the immunogenicity of COVID-19 mRNA vaccines in pregnant and lactating people
timeFrame: Testing will be performed from the time of study enrollment up to one year after sample collection
measure: To evaluate the efficacy of COVID-19 mRNA vaccines in pregnant and lactating people
timeFrame: Testing will be performed from the time of study enrollment up to one year after sample collection
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: William C Golden, MD
role: PRINCIPAL_INVESTIGATOR
References: