<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04432779</url>
  </required_header>
  <id_info>
    <org_study_id>Elikya Covid</org_study_id>
    <nct_id>NCT04432779</nct_id>
  </id_info>
  <brief_title>Impact of COVID-19 Infection During Pregnancy on Newborns and Young Children</brief_title>
  <acronym>ELIKYA COVID</acronym>
  <official_title>Impact of SARS-CoV-2 Infection During Pregnancy on Newborns and Young Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire Saint Pierre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Institute for Medical Immunology (IMI)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Laboratoire Hospitalier Universitaire de Bruxelles (LHUB)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Centre Hospitalier Universitaire Saint Pierre</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aim is to assess impact of COVID-19 infection during pregnancy on outcome of&#xD;
      pregnancy, and on developement of the child in early life.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All pregnant women will be tested for serology during each trimester of pregnancy and at&#xD;
      delivery, together with a nasal swab. Children born to women with positive sawb or serology&#xD;
      will be followed up for 3 years together with a control child born to negative mother.&#xD;
&#xD;
      In positive mothers, maternal antibodies at delivery will be characterized, placental&#xD;
      transfer will be assessed. Persistence of antibodies in children at the age of 1 month and&#xD;
      presence of antibodies in breast milk will be measured.&#xD;
&#xD;
      Occurence of premature birth, low birth weight, miscarriage, congenital malformations will be&#xD;
      compared in positive and negative mothers. Follow up of children over the first 3 years of&#xD;
      life will assess difference in susceptibility to infections and neurological developement in&#xD;
      both groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">May 25, 2020</start_date>
  <completion_date type="Anticipated">June 2024</completion_date>
  <primary_completion_date type="Anticipated">June 2024</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Outcome of pregnancy</measure>
    <time_frame>Up to the delivery</time_frame>
    <description>Incidence of miscarriage, premature delivery, low birth weight, preeclampsia, chorioamnionitis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Prevalence of positive serology to SARS-CoV-2 at delivery</measure>
    <time_frame>At the delivery</time_frame>
    <description>Measure of antibodies in maternal serum at delivery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Transplacental transfer of antibodies to SARS-CoV-2</measure>
    <time_frame>At the delivery</time_frame>
    <description>Measure the ratio of cord blood antibodies on maternal antibodies titers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To characterize placental alterations related to SARS-CoV-2 infection</measure>
    <time_frame>At the delivery</time_frame>
    <description>Placental histology will be performed in women tested positive for SARS-CoV-2 during pregnancy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of maternal antibodies to SARS-CoV-2 in breast milk in breastfeeding mothers</measure>
    <time_frame>At 1 month post delivery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To characterize the immunity transmitted to the newborn to cord blood and its persistence at the age of 1 month of life</measure>
    <time_frame>Up to 1 month post delivery</time_frame>
    <description>Measure of antibodies in cord blood and at the age of 1 month</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical evolution of the children</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>Occurence of infectious disease, neurological development, growth</description>
  </secondary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Anticipated">3000</enrollment>
  <condition>Pregnancy</condition>
  <condition>Covid-19</condition>
  <arm_group>
    <arm_group_label>Women tested positive to SARS-CoV-2 during pregnancy</arm_group_label>
    <description>All women who had a positive nasal swab or a positive serology during pregnancy or at delivery are included.&#xD;
Follow up end at 1 month post delivery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Women tested negative to SARS-CoV-2 during pregnancy</arm_group_label>
    <description>All women who had a positive nasal swab or a positive serology during pregnancy or at delivery are included.&#xD;
No follow up after delivery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Newborns from women tested positive</arm_group_label>
    <description>Newborns born to mothers who had a positive nasal swab or a positive serology during pregnancy or at delivery and who consented the follow up study.&#xD;
Follow up end at 3 years of age.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Newborns from women tested negative</arm_group_label>
    <description>Newborns born to mothers who had no COVID-19 infection during pregnancy or at delivery and who consented the follow up study. These control children will be matched with children from the other group for gestational age and ethnicity.&#xD;
Follow up end at 3 years of age.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>no intervention</intervention_name>
    <description>no intervention</description>
    <arm_group_label>Newborns from women tested negative</arm_group_label>
    <arm_group_label>Newborns from women tested positive</arm_group_label>
    <arm_group_label>Women tested negative to SARS-CoV-2 during pregnancy</arm_group_label>
    <arm_group_label>Women tested positive to SARS-CoV-2 during pregnancy</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Maternal specimens (placental tissue, serum, breast milk), Newborn specimens (umbilical cord&#xD;
      blood)and infant specimens (serum)&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        All women who deliver in the CHU St Pierre and children born to positive mothers and&#xD;
        controls matched on gestational age and ethnicity&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  For pregnant women, all women who deliver in the CHU St Pierre, with oral consent.&#xD;
&#xD;
          -  For children follow up: children born to positive mothers and matched controls after&#xD;
             written consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  none&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tessa Goetghebuer, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre Hospitalier Universitaire Saint Pierre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU SAINT Pierre</name>
      <address>
        <city>Brussels</city>
        <zip>1000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <reference>
    <citation>Dashraath P, Wong JLJ, Lim MXK, Lim LM, Li S, Biswas A, Choolani M, Mattar C, Su LL. Coronavirus disease 2019 (COVID-19) pandemic and pregnancy. Am J Obstet Gynecol. 2020 Jun;222(6):521-531. doi: 10.1016/j.ajog.2020.03.021. Epub 2020 Mar 23.</citation>
    <PMID>32217113</PMID>
  </reference>
  <reference>
    <citation>Di Mascio D, Khalil A, Saccone G, Rizzo G, Buca D, Liberati M, Vecchiet J, Nappi L, Scambia G, Berghella V, D'Antonio F. Outcome of coronavirus spectrum infections (SARS, MERS, COVID-19) during pregnancy: a systematic review and meta-analysis. Am J Obstet Gynecol MFM. 2020 May;2(2):100107. doi: 10.1016/j.ajogmf.2020.100107. Epub 2020 Mar 25.</citation>
    <PMID>32292902</PMID>
  </reference>
  <reference>
    <citation>Alzamora MC, Paredes T, Caceres D, Webb CM, Valdez LM, La Rosa M. Severe COVID-19 during Pregnancy and Possible Vertical Transmission. Am J Perinatol. 2020 Jun;37(8):861-865. doi: 10.1055/s-0040-1710050. Epub 2020 Apr 18.</citation>
    <PMID>32305046</PMID>
  </reference>
  <reference>
    <citation>Muldoon KM, Fowler KB, Pesch MH, Schleiss MR. SARS-CoV-2: Is it the newest spark in the TORCH? J Clin Virol. 2020 Jun;127:104372. doi: 10.1016/j.jcv.2020.104372. Epub 2020 Apr 14.</citation>
    <PMID>32335336</PMID>
  </reference>
  <reference>
    <citation>Dauby N, Goetghebuer T, Kollmann TR, Levy J, Marchant A. Uninfected but not unaffected: chronic maternal infections during pregnancy, fetal immunity, and susceptibility to postnatal infections. Lancet Infect Dis. 2012 Apr;12(4):330-40. doi: 10.1016/S1473-3099(11)70341-3. Epub 2012 Feb 24.</citation>
    <PMID>22364680</PMID>
  </reference>
  <reference>
    <citation>Goetghebuer T, Smolen KK, Adler C, Das J, McBride T, Smits G, Lecomte S, Haelterman E, Barlow P, Piedra PA, van der Klis F, Kollmann TR, Lauffenburger DA, Alter G, Levy J, Marchant A. Initiation of Antiretroviral Therapy Before Pregnancy Reduces the Risk of Infection-related Hospitalization in Human Immunodeficiency Virus-exposed Uninfected Infants Born in a High-income Country. Clin Infect Dis. 2019 Mar 19;68(7):1193-1203. doi: 10.1093/cid/ciy673.</citation>
    <PMID>30215689</PMID>
  </reference>
  <reference>
    <citation>McHenry MS, McAteer CI, Oyungu E, McDonald BC, Bosma CB, Mpofu PB, Deathe AR, Vreeman RC. Neurodevelopment in Young Children Born to HIV-Infected Mothers: A Meta-analysis. Pediatrics. 2018 Feb;141(2):e20172888. doi: 10.1542/peds.2017-2888.</citation>
    <PMID>29374109</PMID>
  </reference>
  <reference>
    <citation>Vohr BR, Poggi Davis E, Wanke CA, Krebs NF. Neurodevelopment: The Impact of Nutrition and Inflammation During Preconception and Pregnancy in Low-Resource Settings. Pediatrics. 2017 Apr;139(Suppl 1):S38-S49. doi: 10.1542/peds.2016-2828F.</citation>
    <PMID>28562247</PMID>
  </reference>
  <reference>
    <citation>Sutton D, Fuchs K, D'Alton M, Goffman D. Universal Screening for SARS-CoV-2 in Women Admitted for Delivery. N Engl J Med. 2020 May 28;382(22):2163-2164. doi: 10.1056/NEJMc2009316. Epub 2020 Apr 13. No abstract available.</citation>
    <PMID>32283004</PMID>
  </reference>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>June 15, 2020</study_first_submitted>
  <study_first_submitted_qc>June 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>October 7, 2022</last_update_submitted>
  <last_update_submitted_qc>October 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 10, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Covid-19</keyword>
  <keyword>Pregnancy</keyword>
  <keyword>antibodies</keyword>
  <keyword>congenital SARS infection</keyword>
  <keyword>breast milk</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04432779
org study id: Elikya Covid
nct id: NCT04432779
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aim is to assess impact of COVID-19 infection during pregnancy on outcome of
      pregnancy, and on developement of the child in early life.
All pregnant women will be tested for serology during each trimester of pregnancy and at
      delivery, together with a nasal swab. Children born to women with positive sawb or serology
      will be followed up for 3 years together with a control child born to negative mother.

      In positive mothers, maternal antibodies at delivery will be characterized, placental
      transfer will be assessed. Persistence of antibodies in children at the age of 1 month and
      presence of antibodies in breast milk will be measured.

      Occurence of premature birth, low birth weight, miscarriage, congenital malformations will be
      compared in positive and negative mothers. Follow up of children over the first 3 years of
      life will assess difference in susceptibility to infections and neurological developement in
      both groups.
observational model: Cohort
time perspective: Prospective
measure: Outcome of pregnancy
time frame: Up to the delivery
description: Incidence of miscarriage, premature delivery, low birth weight, preeclampsia, chorioamnionitis
measure: Prevalence of positive serology to SARS-CoV-2 at delivery
time frame: At the delivery
description: Measure of antibodies in maternal serum at delivery
measure: Transplacental transfer of antibodies to SARS-CoV-2
time frame: At the delivery
description: Measure the ratio of cord blood antibodies on maternal antibodies titers
measure: To characterize placental alterations related to SARS-CoV-2 infection
time frame: At the delivery
description: Placental histology will be performed in women tested positive for SARS-CoV-2 during pregnancy
measure: Presence of maternal antibodies to SARS-CoV-2 in breast milk in breastfeeding mothers
time frame: At 1 month post delivery
measure: To characterize the immunity transmitted to the newborn to cord blood and its persistence at the age of 1 month of life
time frame: Up to 1 month post delivery
description: Measure of antibodies in cord blood and at the age of 1 month
measure: Clinical evolution of the children
time frame: Up to 3 years
description: Occurence of infectious disease, neurological development, growth
arm group label: Women tested positive to SARS-CoV-2 during pregnancy
description: All women who had a positive nasal swab or a positive serology during pregnancy or at delivery are included.
Follow up end at 1 month post delivery.
arm group label: Women tested negative to SARS-CoV-2 during pregnancy
description: All women who had a positive nasal swab or a positive serology during pregnancy or at delivery are included.
No follow up after delivery.
arm group label: Newborns from women tested positive
description: Newborns born to mothers who had a positive nasal swab or a positive serology during pregnancy or at delivery and who consented the follow up study.
Follow up end at 3 years of age.
arm group label: Newborns from women tested negative
description: Newborns born to mothers who had no COVID-19 infection during pregnancy or at delivery and who consented the follow up study. These control children will be matched with children from the other group for gestational age and ethnicity.
Follow up end at 3 years of age.
intervention type: Other
intervention name: no intervention
description: no intervention
arm group label: Newborns from women tested negative
arm group label: Newborns from women tested positive
arm group label: Women tested negative to SARS-CoV-2 during pregnancy
arm group label: Women tested positive to SARS-CoV-2 during pregnancy
Maternal specimens (placental tissue, serum, breast milk), Newborn specimens (umbilical cord
      blood)and infant specimens (serum)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Tessa Goetghebuer, MD PhD
role: Principal Investigator
affiliation: Centre Hospitalier Universitaire Saint Pierre
facility: 
country: Belgium
citation: Dashraath P, Wong JLJ, Lim MXK, Lim LM, Li S, Biswas A, Choolani M, Mattar C, Su LL. Coronavirus disease 2019 (COVID-19) pandemic and pregnancy. Am J Obstet Gynecol. 2020 Jun;222(6):521-531. doi: 10.1016/j.ajog.2020.03.021. Epub 2020 Mar 23.
PMID: 32217113
citation: Di Mascio D, Khalil A, Saccone G, Rizzo G, Buca D, Liberati M, Vecchiet J, Nappi L, Scambia G, Berghella V, D'Antonio F. Outcome of coronavirus spectrum infections (SARS, MERS, COVID-19) during pregnancy: a systematic review and meta-analysis. Am J Obstet Gynecol MFM. 2020 May;2(2):100107. doi: 10.1016/j.ajogmf.2020.100107. Epub 2020 Mar 25.
PMID: 32292902
citation: Alzamora MC, Paredes T, Caceres D, Webb CM, Valdez LM, La Rosa M. Severe COVID-19 during Pregnancy and Possible Vertical Transmission. Am J Perinatol. 2020 Jun;37(8):861-865. doi: 10.1055/s-0040-1710050. Epub 2020 Apr 18.
PMID: 32305046
citation: Muldoon KM, Fowler KB, Pesch MH, Schleiss MR. SARS-CoV-2: Is it the newest spark in the TORCH? J Clin Virol. 2020 Jun;127:104372. doi: 10.1016/j.jcv.2020.104372. Epub 2020 Apr 14.
PMID: 32335336
citation: Dauby N, Goetghebuer T, Kollmann TR, Levy J, Marchant A. Uninfected but not unaffected: chronic maternal infections during pregnancy, fetal immunity, and susceptibility to postnatal infections. Lancet Infect Dis. 2012 Apr;12(4):330-40. doi: 10.1016/S1473-3099(11)70341-3. Epub 2012 Feb 24.
PMID: 22364680
citation: Goetghebuer T, Smolen KK, Adler C, Das J, McBride T, Smits G, Lecomte S, Haelterman E, Barlow P, Piedra PA, van der Klis F, Kollmann TR, Lauffenburger DA, Alter G, Levy J, Marchant A. Initiation of Antiretroviral Therapy Before Pregnancy Reduces the Risk of Infection-related Hospitalization in Human Immunodeficiency Virus-exposed Uninfected Infants Born in a High-income Country. Clin Infect Dis. 2019 Mar 19;68(7):1193-1203. doi: 10.1093/cid/ciy673.
PMID: 30215689
citation: McHenry MS, McAteer CI, Oyungu E, McDonald BC, Bosma CB, Mpofu PB, Deathe AR, Vreeman RC. Neurodevelopment in Young Children Born to HIV-Infected Mothers: A Meta-analysis. Pediatrics. 2018 Feb;141(2):e20172888. doi: 10.1542/peds.2017-2888.
PMID: 29374109
citation: Vohr BR, Poggi Davis E, Wanke CA, Krebs NF. Neurodevelopment: The Impact of Nutrition and Inflammation During Preconception and Pregnancy in Low-Resource Settings. Pediatrics. 2017 Apr;139(Suppl 1):S38-S49. doi: 10.1542/peds.2016-2828F.
PMID: 28562247
citation: Sutton D, Fuchs K, D'Alton M, Goffman D. Universal Screening for SARS-CoV-2 in Women Admitted for Delivery. N Engl J Med. 2020 May 28;382(22):2163-2164. doi: 10.1056/NEJMc2009316. Epub 2020 Apr 13. No abstract available.
PMID: 32283004
responsible party type: Sponsor
mesh term: Infections
mesh term: COVID-19
sharing ipd: No