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COVID-19 Pregnancy Related Immunological, Clinical and Epidemiological Factors and Perinatal Outcomes (COVID-PRICE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04659759
Recruitment Status : Recruiting
First Posted : December 9, 2020
Last Update Posted : March 5, 2021
Sponsor:
Collaborator:
Nemours
Information provided by (Responsible Party):
Thomas Jefferson University

Brief Summary:
This is a prospective cohort study of pregnant patients at an urban academic center diagnosed with perinatal COVID-19 infection, followed up to 6 weeks postpartum.

Condition or disease Intervention/treatment
Covid19 Other: COVID-19 exposure Biological: COVID-19 vaccine

Detailed Description:
This proposal aims to provide a multi-faceted approach to addressing perinatal COVID-19 infection by (1) improving our understanding of SARS-CoV-2 antibody specificity and durability over the course of pregnancy/postpartum in mother/baby dyad (2) understanding the downstream implications of maternal systemic inflammatory response with COVID-19 infection through study of fetal inflammatory response, placental pathology, and perinatal outcomes, and (3) to evaluate the interplay between socioeconomic characteristics, COVID-19, and early neonatal outcomes. (4) Evaluate antibody generation and durability in pregnant/breastfeeding women who receive any form of the COVID-19 vaccine

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: COVID-19 in Pregnancy: Utilizing Immunology Through Epidemiology to Improve Perinatal/Neonatal Outcomes
Actual Study Start Date : November 17, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : June 30, 2022

Group/Cohort Intervention/treatment
COVID-19 Positive
Patients diagnosed with COVID-19 during pregnancy or while breastfeeding
Other: COVID-19 exposure
COVID-19 exposure during pregnancy

COVID-19 vaccine
Patients who receive COVID-19 vaccine during pregnancy or while breastfeeding
Biological: COVID-19 vaccine
Receipt of any COVID-19 vaccine

Controls
Reproductive age women exposed to COVID-19 vaccine
Pregnant Control
Pregnant women who delivered at TJUH, COVID negative



Primary Outcome Measures :
  1. Maternal COVID-19 serology (IgG and IgM) [ Time Frame: 6 weeks post partum ]
    IgG/IgM time profile through pregnancy up to 6 weeks post partum for those exposed to COVID-19

  2. Maternal/neonatal IgG and IgM concordance [ Time Frame: Delivery ]
    IgG/IgM at delivery in mother/neonate through maternal and cord blood sampling

  3. Maternal COVID serology time/profile following vaccination [ Time Frame: 6 months ]
    Baseline, 1m, 3m, 6m post second vaccine dose

  4. Breastmilk Serology [ Time Frame: 6months ]
    Breastmilk IgG and IgA time profile following COVID vaccine in breastfeeding women


Secondary Outcome Measures :
  1. Breastmilk Serology [ Time Frame: Delivery ]
    COVID-19 IgG and IgA in breast milk

  2. Breastmilk Serology [ Time Frame: 6 weeks post partum ]
    COVID-19 IgG and IgA in breastmilk

  3. Cytokine [ Time Frame: Delivery ]
    Compare maternal COVID (+) and COVID (-) cytokine panel

  4. Neonatal cytokine [ Time Frame: Delivery ]
    Compare cordblood cytokine panel between COVID(+) and COVID (-) at delivery

  5. COVID disease vs vaccination immune response [ Time Frame: 6 months ]
    Compare maternal IgG concentration time/profile in those with COVID disease vs COVID vaccine

  6. COVID vaccine in pregnant vs nonpregnant [ Time Frame: 6 months ]
    Compare maternal IgG concentration/time profile in pregnant vs non-pregnant women with vaccine


Biospecimen Retention:   Samples Without DNA
  • Maternal serum/plasma

    • SARS-CoV-2 serology
    • Cytokine/chemokine panel
  • Cord blood serum/plasm

    • SARS-CoV-2 serology
    • Cytokine/chemokine panel
    • DNA methylation, miRNA/mRNA exression
  • Breastmilk o SARS-CoV-2 serology


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pregnant patients diagnosed with COVID-19 at any point during pregnancy or within 6 weeks post partum
Criteria

Inclusion Criteria:

  • Diagnosis of COVID-19 in pregnancy or within 6 months post partum
  • Planned delivery at Thomas Jefferson University Hospital

Exclusion Criteria:

  • Declines routine COVID testing on admission
  • In active labor/pain/otherwise unable to provide consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04659759


Contacts
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Contact: Rupsa C Boelig, MD 215-955-9196 rupsa.boelig@jefferson.edu
Contact: Emily Oliver, MD emily.oliver@jefferson.edu

Locations
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United States, Pennsylvania
Thomas Jefferson University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Rupsa C Boelig, MD    215-955-9196    rupsa.boelig@jefferson.edu   
Sponsors and Collaborators
Thomas Jefferson University
Nemours
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Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT04659759    
Other Study ID Numbers: 20F.1043
First Posted: December 9, 2020    Key Record Dates
Last Update Posted: March 5, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases