<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/NCT04465474</url>
  </required_header>
  <id_info>
    <org_study_id>COVID-MAP</org_study_id>
    <nct_id>NCT04465474</nct_id>
  </id_info>
  <brief_title>Coronavirus Disease 2019 (COVID-19) During Pregnancy: Prevalence of Seroconversion, Effect on Maternal and Perinatal Outcomes and Risk of Vertical Transmission (COVID-MAP)</brief_title>
  <official_title>Coronavirus Disease 2019 (COVID-19) During Pregnancy: Prevalence of Seroconversion, Effect on Maternal and Perinatal Outcomes and Risk of Vertical Transmission (COVID-MAP)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Peking University First Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital Universitario de Torrejón</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Queen Mary Hospital, Hong Kong</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Pamela Youde Nethersole Eastern Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Queen Elizabeth Hospital, Hong Kong</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>United Christian Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Kwong Wah Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Princess Margaret Hospital, Hong Kong</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tuen Mun Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Chinese University of Hong Kong</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>
      The objectives of this proposal are to: 1) determine the rate of SARS-CoV-2 seroconversion in&#xD;
      unselected pregnant women in Hong Kong; 2) determine the rate of SARS-CoV-2 infection in&#xD;
      women presenting with miscarriage and stillbirth; 3) follow the pregnancy course and&#xD;
      perinatal outcome of confirmed COVID-19-infected pregnant cases; 4) determine the risk and&#xD;
      characteristics of vertical transmission; and 5) evaluate the placental barrier, immune&#xD;
      response and fetal damage in vertical transmission of SARS-CoV-2. A series of longitudinal&#xD;
      and cross-sectional observational studies, and a laboratory-based study will be conducted to&#xD;
      fulfil the 5 objectives.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      With over 10 million individuals infected worldwide, the coronavirus disease 2019 (COVID-19),&#xD;
      caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), is a global&#xD;
      public health crisis. It is recognized that pregnant women are at an increased risk of&#xD;
      acquiring viral respiratory infection and developing severe pneumonia due to the physiologic&#xD;
      changes in their immune and cardiopulmonary systems. Previous studies have attempted to&#xD;
      determine maternal and perinatal outcome and potential risk of vertical transmission in&#xD;
      pregnant women affected by COVID-19, however, relevant clinical data and biological samples&#xD;
      have not been collected in a systematic manner. The research project will engage in&#xD;
      collaborative research across obstetricians/maternal-fetal medicine subspecialists,&#xD;
      gynecologist, infectious disease specialists, pediatrician, developmental and molecular&#xD;
      biologists and bioinformatician between the CUHK, China and Spain. The objectives of this&#xD;
      proposal are to: 1) determine the rate of SARS-CoV-2 seroconversion in unselected pregnant&#xD;
      women in Hong Kong; 2) determine the rate of SARS-CoV-2 infection in women presenting with&#xD;
      miscarriage and stillbirth; 3) follow the pregnancy course and perinatal outcome of confirmed&#xD;
      COVID-19-infected pregnant cases; 4) determine the risk and characteristics of vertical&#xD;
      transmission; and 5) evaluate the placental barrier, immune response and fetal damage in&#xD;
      vertical transmission of SARS-CoV-2. A series of longitudinal and cross-sectional&#xD;
      observational studies, and a laboratory-based study will be conducted to fulfil the 5&#xD;
      objectives.&#xD;
&#xD;
      Results generated will inform obstetrics and gynecology, pediatric and infectious disease&#xD;
      scientific communities as well as public health specialists and policy makers regarding: (1)&#xD;
      the estimated seroconversion rate in women of childbearing age; these results will help (i)&#xD;
      improve the approach to care for pregnancy and childbirth during the COVID-19 outbreak; and&#xD;
      (ii) formulate preventive measures to be implemented specifically for pregnant women in&#xD;
      reducing risk of infection and associated complications to both the women and their unborn&#xD;
      child; (2) the impact of COVID-19 on maternal and perinatal outcomes; data from high-quality&#xD;
      research will inform practice during the COVID-19 outbreak, guiding healthcare professionals&#xD;
      on how to adjust the management approach to infected pregnant women and the exact risks the&#xD;
      infection poses to the babies; (3) the risk of vertical transmission at different stages of&#xD;
      pregnancy and its sequelae; findings of this study will guide counselling, decision making&#xD;
      and clinical management; (4) the identification of cellular site of viral entry and&#xD;
      replication in the maternal-fetal interface that would be instrumental in designing&#xD;
      therapeutic measures to cease vertical transmission and developing therapeutic treatments.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 1, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">April 30, 2022</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <target_duration>6 Months</target_duration>
  <primary_outcome>
    <measure>Seroconversion during pregnancy - DSS1</measure>
    <time_frame>At DSS1 (Around 11-13 weeks gestation)</time_frame>
    <description>Mother</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Seroconversion during pregnancy - At delivery</measure>
    <time_frame>At Delivery</time_frame>
    <description>Mother</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pregnancy loss</measure>
    <time_frame>At pregnancy loss</time_frame>
    <description>Mother (1st); Mother and abortus/stillborn baby(2nd)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pregnancy course and perinatal outcome</measure>
    <time_frame>From date of recruited until the date of delivery</time_frame>
    <description>Mother and Baby</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Vertical transmission</measure>
    <time_frame>At Newborn 0 hours of life, mother immediately after delivery</time_frame>
    <description>Mother and Baby</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Vertical transmission</measure>
    <time_frame>At Newborn 7 days of life</time_frame>
    <description>Mother and Baby</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Vertical transmission</measure>
    <time_frame>At Newborn 14 days of life</time_frame>
    <description>Mother and Baby</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Vertical transmission</measure>
    <time_frame>At Newborn 6 months of life</time_frame>
    <description>Mother and Baby</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Vertical transmission</measure>
    <time_frame>At Newborn 18 months of life</time_frame>
    <description>Mother and Baby</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Potential mechanisms for vertical transmission 1) placental barrier, 2) immune response and 3) fetal damage of vertical transmission and mechanism in SARS-CoV-2 infection.</measure>
    <time_frame>through study completion, up to 2 years</time_frame>
    <description>Mother and Baby</description>
  </primary_outcome>
  <enrollment type="Anticipated">3000</enrollment>
  <condition>COVID-19</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Non Intervention</intervention_name>
    <description>It's an observational study, no intervention involves.</description>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Biological samples Miscarriage: POC, maternal blood&#xD;
&#xD;
      Stillbirth: Maternal vaginal swab, amniotic fluid, amnion-chorion interface swab, placental&#xD;
      tissue, fetal blood, fetal throat swab, maternal blood&#xD;
&#xD;
      Delivery: Maternal blood before delivery At or after delivery: amniotic fluid, cord blood,&#xD;
      placental tissue, amnion-chorion interface swab, neonatal throat swab Breast milk from both&#xD;
      breasts for the duration of hospitalization Newborn throat swab at 24 hours of life Newborn&#xD;
      stool samples for the duration of hospitalization Infant throat swab and stool sample at 7&#xD;
      days of age Infant blood at 14 days, 6 months &amp; 18 months of age&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Pregnant women&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Objective 1: Seroconversion during pregnancy&#xD;
&#xD;
        Inclusion criteria:&#xD;
&#xD;
          -  Pregnant women who attended for Down syndrome screening (DSS) at 11-13 weeks&#xD;
&#xD;
          -  Had serum sample taken between 1 November 2019 and 1 June 2020 consented for stored&#xD;
             serum for future research&#xD;
&#xD;
          -  Intended to deliver at the booking hospital.&#xD;
&#xD;
        Objective 2: SARS-CoV-2 and pregnancy loss&#xD;
&#xD;
        Inclusion criteria:&#xD;
&#xD;
        •Pregnant women presenting with first and second trimester miscarriage in Hong Kong and&#xD;
        Spain, as well as those with stillbirth during periods of 6 and 12 months, respectively.&#xD;
&#xD;
        Objective 3: Pregnancy course and perinatal outcome&#xD;
&#xD;
        Inclusion criteria:&#xD;
&#xD;
        •Pregnant women affected by COVID-19&#xD;
&#xD;
        Objective 4: Vertical transmission&#xD;
&#xD;
        Inclusion criteria:&#xD;
&#xD;
        •Pregnant women affected by COVID-19&#xD;
&#xD;
        Objective 5: Potential mechanisms for vertical transmission&#xD;
&#xD;
        Inclusion criteria:&#xD;
&#xD;
        •Pregnant women affected by COVID-19&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Liona POON</last_name>
    <phone>(852) 3505 2582</phone>
    <email>liona.poon@cuhk.edu.hk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Equal CHEN</last_name>
    <phone>(852) 3505 1536</phone>
    <email>equalchen@cuhk.edu.hk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Peking University First Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Huixia YANG, MD, PhD</last_name>
      <email>yanghuixia@bjmu.edu.cn</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Kwong Wah Hospital</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wing Cheong LEUNG, MBBS, MRCOG, FHKAM, FHKCOG</last_name>
      <phone>3517 5053</phone>
      <email>leungwc@ha.org.hk</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Pamela Youde Nethersole Eastern Hospital</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chung Nin LEE, MBBS, MMedSc, FRCOG, FHKCOG</last_name>
      <phone>2595 6815</phone>
      <email>lcnz01@ha.org.ha</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Princess Margaret Hospital</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tsz-Kin LO, MBBS, MRCOG, FHKCOG</last_name>
      <email>lotk@ha.org.hk</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Queen Elizabeth Hospital</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wei Ling Teresa MA, FRCOG, FHKAM</last_name>
      <phone>3506 2246</phone>
      <email>mawlt@ha.org.hk</email>
    </contact>
    <investigator>
      <last_name>Nga Yui, Florrie YU, MBChB, MRCOG, FHKAM (O&amp;G)</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ngai Man CHAN, MBBS, MSc</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Queen Mary Hospital</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ka Wang CHEUNG, MBBS, MRCOG; FHKCOG; FHKAM</last_name>
      <phone>2255 4267</phone>
      <email>ckw028a@ha.org.hk</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Chinese University of Hong Kong, Prince of Wales Hospital</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Liona Chiu Yee Poon, MBBS, MRCOG, MD</last_name>
      <phone>(852) 3505 2582</phone>
      <email>liona.poon@cuhk.edu.hk</email>
    </contact>
    <contact_backup>
      <last_name>Equal CHEN</last_name>
      <phone>(852) 3505 1536</phone>
      <email>equalchen@cuhk.edu.hk</email>
    </contact_backup>
    <investigator>
      <last_name>Annie SY HUI, MBBS, MRCOG, FHKCOG, FHKAM</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ada WT TSE, MBChB</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Tuen Mun Hospital</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Po Lam SO</last_name>
      <phone>2468 5918</phone>
      <email>soplp@ha.org.hk</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>United Christian Hospital</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Choi Wah KONG, MBChB, MRCOG, FHKAM, FHKCOG</last_name>
      <phone>3949 3444</phone>
      <email>kcw305@ha.org.hk</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de Torrejón</name>
      <address>
        <city>Torrejón De Ardoz</city>
        <state>Madrid</state>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maria del Mar GIL, PhD</last_name>
      <email>mariadelmar.gil@ufv.es</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
    <country>Hong Kong</country>
    <country>Spain</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>July 3, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>January 25, 2021</last_update_submitted>
  <last_update_submitted_qc>January 25, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 27, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese University of Hong Kong</investigator_affiliation>
    <investigator_full_name>Chiu Yee Liona Poon</investigator_full_name>
    <investigator_title>Prof Poon, Chiu Yee Liona</investigator_title>
  </responsible_party>
  <keyword>pregnancy</keyword>
  <keyword>vertical transmission</keyword>
  <keyword>pregnancy loss</keyword>
  <keyword>ACE2 TMPRSS2</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 2, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/74/NCT04465474/Prot_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT04465474
org study id: COVID-MAP
nct id: NCT04465474
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objectives of this proposal are to: 1) determine the rate of SARS-CoV-2 seroconversion in
      unselected pregnant women in Hong Kong; 2) determine the rate of SARS-CoV-2 infection in
      women presenting with miscarriage and stillbirth; 3) follow the pregnancy course and
      perinatal outcome of confirmed COVID-19-infected pregnant cases; 4) determine the risk and
      characteristics of vertical transmission; and 5) evaluate the placental barrier, immune
      response and fetal damage in vertical transmission of SARS-CoV-2. A series of longitudinal
      and cross-sectional observational studies, and a laboratory-based study will be conducted to
      fulfil the 5 objectives.
With over 10 million individuals infected worldwide, the coronavirus disease 2019 (COVID-19),
      caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), is a global
      public health crisis. It is recognized that pregnant women are at an increased risk of
      acquiring viral respiratory infection and developing severe pneumonia due to the physiologic
      changes in their immune and cardiopulmonary systems. Previous studies have attempted to
      determine maternal and perinatal outcome and potential risk of vertical transmission in
      pregnant women affected by COVID-19, however, relevant clinical data and biological samples
      have not been collected in a systematic manner. The research project will engage in
      collaborative research across obstetricians/maternal-fetal medicine subspecialists,
      gynecologist, infectious disease specialists, pediatrician, developmental and molecular
      biologists and bioinformatician between the CUHK, China and Spain. The objectives of this
      proposal are to: 1) determine the rate of SARS-CoV-2 seroconversion in unselected pregnant
      women in Hong Kong; 2) determine the rate of SARS-CoV-2 infection in women presenting with
      miscarriage and stillbirth; 3) follow the pregnancy course and perinatal outcome of confirmed
      COVID-19-infected pregnant cases; 4) determine the risk and characteristics of vertical
      transmission; and 5) evaluate the placental barrier, immune response and fetal damage in
      vertical transmission of SARS-CoV-2. A series of longitudinal and cross-sectional
      observational studies, and a laboratory-based study will be conducted to fulfil the 5
      objectives.

      Results generated will inform obstetrics and gynecology, pediatric and infectious disease
      scientific communities as well as public health specialists and policy makers regarding: (1)
      the estimated seroconversion rate in women of childbearing age; these results will help (i)
      improve the approach to care for pregnancy and childbirth during the COVID-19 outbreak; and
      (ii) formulate preventive measures to be implemented specifically for pregnant women in
      reducing risk of infection and associated complications to both the women and their unborn
      child; (2) the impact of COVID-19 on maternal and perinatal outcomes; data from high-quality
      research will inform practice during the COVID-19 outbreak, guiding healthcare professionals
      on how to adjust the management approach to infected pregnant women and the exact risks the
      infection poses to the babies; (3) the risk of vertical transmission at different stages of
      pregnancy and its sequelae; findings of this study will guide counselling, decision making
      and clinical management; (4) the identification of cellular site of viral entry and
      replication in the maternal-fetal interface that would be instrumental in designing
      therapeutic measures to cease vertical transmission and developing therapeutic treatments.
observational model: Other
time perspective: Other
measure: Seroconversion during pregnancy - DSS1
time frame: At DSS1 (Around 11-13 weeks gestation)
description: Mother
measure: Seroconversion during pregnancy - At delivery
time frame: At Delivery
description: Mother
measure: Pregnancy loss
time frame: At pregnancy loss
description: Mother (1st); Mother and abortus/stillborn baby(2nd)
measure: Pregnancy course and perinatal outcome
time frame: From date of recruited until the date of delivery
description: Mother and Baby
measure: Vertical transmission
time frame: At Newborn 0 hours of life, mother immediately after delivery
description: Mother and Baby
measure: Vertical transmission
time frame: At Newborn 7 days of life
description: Mother and Baby
measure: Vertical transmission
time frame: At Newborn 14 days of life
description: Mother and Baby
measure: Vertical transmission
time frame: At Newborn 6 months of life
description: Mother and Baby
measure: Vertical transmission
time frame: At Newborn 18 months of life
description: Mother and Baby
measure: Potential mechanisms for vertical transmission 1) placental barrier, 2) immune response and 3) fetal damage of vertical transmission and mechanism in SARS-CoV-2 infection.
time frame: through study completion, up to 2 years
description: Mother and Baby
intervention type: Other
intervention name: Non Intervention
description: It's an observational study, no intervention involves.
Biological samples Miscarriage: POC, maternal blood

      Stillbirth: Maternal vaginal swab, amniotic fluid, amnion-chorion interface swab, placental
      tissue, fetal blood, fetal throat swab, maternal blood

      Delivery: Maternal blood before delivery At or after delivery: amniotic fluid, cord blood,
      placental tissue, amnion-chorion interface swab, neonatal throat swab Breast milk from both
      breasts for the duration of hospitalization Newborn throat swab at 24 hours of life Newborn
      stool samples for the duration of hospitalization Infant throat swab and stool sample at 7
      days of age Infant blood at 14 days, 6 months & 18 months of age
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Liona POON
phone: (852) 3505 2582
email: liona.poon@cuhk.edu.hk
last name: Equal CHEN
phone: (852) 3505 1536
email: equalchen@cuhk.edu.hk
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: China
country: Hong Kong
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Chinese University of Hong Kong
investigator full name: Chiu Yee Liona Poon
investigator title: Prof Poon, Chiu Yee Liona
mesh term: COVID-19
provided document: 