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

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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

Tracking Information
First Submitted Date December 7, 2020
First Posted Date December 9, 2020
Last Update Posted Date March 5, 2021
Actual Study Start Date November 17, 2020
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 25, 2021)
  • 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
  • Maternal/neonatal IgG and IgM concordance [ Time Frame: Delivery ]
    IgG/IgM at delivery in mother/neonate through maternal and cord blood sampling
  • Maternal COVID serology time/profile following vaccination [ Time Frame: 6 months ]
    Baseline, 1m, 3m, 6m post second vaccine dose
  • Breastmilk Serology [ Time Frame: 6months ]
    Breastmilk IgG and IgA time profile following COVID vaccine in breastfeeding women
Original Primary Outcome Measures
 (submitted: December 7, 2020)
  • 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
  • Maternal/neonatal IgG and IgM concordance [ Time Frame: Delivery ]
    IgG/IgM at delivery in mother/neonate through maternal and cord blood sampling
Change History
Current Secondary Outcome Measures
 (submitted: January 25, 2021)
  • Breastmilk Serology [ Time Frame: Delivery ]
    COVID-19 IgG and IgA in breast milk
  • Breastmilk Serology [ Time Frame: 6 weeks post partum ]
    COVID-19 IgG and IgA in breastmilk
  • Cytokine [ Time Frame: Delivery ]
    Compare maternal COVID (+) and COVID (-) cytokine panel
  • Neonatal cytokine [ Time Frame: Delivery ]
    Compare cordblood cytokine panel between COVID(+) and COVID (-) at delivery
  • COVID disease vs vaccination immune response [ Time Frame: 6 months ]
    Compare maternal IgG concentration time/profile in those with COVID disease vs COVID vaccine
  • COVID vaccine in pregnant vs nonpregnant [ Time Frame: 6 months ]
    Compare maternal IgG concentration/time profile in pregnant vs non-pregnant women with vaccine
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title COVID-19 Pregnancy Related Immunological, Clinical and Epidemiological Factors and Perinatal Outcomes
Official Title COVID-19 in Pregnancy: Utilizing Immunology Through Epidemiology to Improve Perinatal/Neonatal Outcomes
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.
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
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
  • 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
Sampling Method Non-Probability Sample
Study Population Pregnant patients diagnosed with COVID-19 at any point during pregnancy or within 6 weeks post partum
Condition Covid19
Intervention
  • Other: COVID-19 exposure
    COVID-19 exposure during pregnancy
  • Biological: COVID-19 vaccine
    Receipt of any COVID-19 vaccine
Study Groups/Cohorts
  • COVID-19 Positive
    Patients diagnosed with COVID-19 during pregnancy or while breastfeeding
    Intervention: Other: COVID-19 exposure
  • COVID-19 vaccine
    Patients who receive COVID-19 vaccine during pregnancy or while breastfeeding
    Intervention: Biological: COVID-19 vaccine
  • Controls
    Reproductive age women exposed to COVID-19 vaccine
  • Pregnant Control
    Pregnant women who delivered at TJUH, COVID negative
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 25, 2021)
300
Original Estimated Enrollment
 (submitted: December 7, 2020)
50
Estimated Study Completion Date June 30, 2022
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Female
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Rupsa C Boelig, MD 215-955-9196 rupsa.boelig@jefferson.edu
Contact: Emily Oliver, MD emily.oliver@jefferson.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04659759
Other Study ID Numbers 20F.1043
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Thomas Jefferson University
Study Sponsor Thomas Jefferson University
Collaborators Nemours
Investigators Not Provided
PRS Account Thomas Jefferson University
Verification Date March 2021