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Principal Investigator: Patricia L Hibberd
Organization: BOSTON UNIVERSITY MEDICAL CAMPUS
Fiscal Year: 2023
Award: $534,998
Funding agency: Eunice Kennedy Shriver National Institute of Child Health and Human Development
Coronavirus disease 2019 (COVID-19) caused by Severe Acute Respiratory Syndrome Corona Virus 2 (SARS-
CoV-2) was first reported in Wuhan, Hubei Province of China in December 2019 and by early 2021, there have
been more than 100 million cases of COVID-19 globally. The consequences of COVID-19 in pregnant women
in high/upper middle-income countries are under intensive investigation. There are few parallel studies in
low/lower middle- income countries (LMIC) and data on COVID-19 infection in high-income countries may not
be generalizable to LMIC. Given the large number of the world’s births that occur in LMIC, there is an urgent
need to understand the risk of COVID-19 (and other respiratory viruses (ORV), particularly influenza) to pregnant
women and newborns. Our group recently led the Indian site of the Centers for Disease Control and Prevention
study on the impact of laboratory confirmed influenza in pregnant women in 3 LMICs, finding that influenza was
associated with late pregnancy loss and reduced mean birthweight. Leveraging this recently completed study
and 10 years of experience of studying ~10,000 pregnant women a year in Central India, we now propose the
“Influenza & COVID Obstetric and Perinatal Epidemiology (ICOPE) Study in India.” ICOPE will enrol 10,000
pregnant women presenting to a large obstetric hospital in Nagpur, India for antenatal care. Important features
of our study include: (i) documented ability to recruit women in the first trimester of pregnancy (ultrasound
confirmed); (ii) twice weekly follow-up for COVID-19/ORV/Influenza symptoms, combined with laboratory testing
for symptomatic and asymptomatic infection (reverse transcription–polymerase chain reaction testing of
nasopharyngeal swabs and frequent collection of dried blood spots for COVID IgG and IgM) during pregnancy
through day 7 post-partum. Neonates with critical illness will be assessed for COVID-19 and influenza and dried
blood spots will be obtained for COVID antibodies on day 7 of life. Pregnant women admitted with COVID-19
will have specimens obtained to evaluate trajectories of inflammatory cytokines. We will biobank dried blood
spots for future studies. Our specific aims are to: (1) determine the prevalence, incidence and maximal severity
of symptomatic or asymptomatic COVID-19 in pregnant women to day 7 postpartum and whether influenza/ORV
infection or vaccination modifies and pre-term birth mediates this risk; (2) determine the effect of maternal
COVID-19 infection on the fetus and/or neonate to day 7 of life; and whether influenza/ORV or vaccination
modifies and pre-term birth mediates this risk; (3) characterize patterns and trajectories of host
response/inflammatory biomarkers as potential mediators of COVID-19±influenza infection on progression to
severe illness in pregnant women/mothers admitted with COVID-19. Modifiers include vaccination. ICOPE is
well positioned to provide information on the impact of COVID-19 and ORV, across all trimesters, over time in a
LMIC setting.
Terms: <0-11 years old><0-4 weeks old><19S Gamma Globulin><1st trimester><2019 novel corona virus><2019 novel coronavirus><2019-nCoV><7S Gamma Globulin><Active Follow-up><Acute-Phase Proteins><Acute-Phase Reactants><Address><Admission><Admission activity><Antibodies><Biological Markers><Birth><Birth Weight><Blood><Blood Reticuloendothelial System><COVID><COVID disease severity><COVID infected patient><COVID patient><COVID positive patient><COVID severity><COVID-19><COVID-19 affected><COVID-19 consequence><COVID-19 disease severity><COVID-19 effect><COVID-19 impact><COVID-19 impacted><COVID-19 infected patient><COVID-19 infection><COVID-19 patient><COVID-19 positive patient><COVID-19 related risk><COVID-19 risk><COVID-19 risk factor><COVID-19 severity><COVID-19 virus><COVID-19 virus infection><COVID19><COVID19 disease severity><COVID19 infection><COVID19 patient><COVID19 positive patient><COVID19 severity><COVID19 virus><CV-19><CV19><Centers for Disease Control><Centers for Disease Control and Prevention><Centers for Disease Control and Prevention (U.S.)><Child><Child Youth><Children (0-21)><China><CoV disease><CoV-2><CoV2><Cohort Studies><Collaborations><Collection><Communicable Diseases><Concurrent Studies><Country><Critical Illness><Critically Ill><Data><Discipline of obstetrics><Disease><Disorder><Dryness><EPH Gestosis><Early Placental Phase><Economic Income><Economical Income><Emergencies><Emergency Situation><Enrollment><Epidemiologic Research><Epidemiologic Studies><Epidemiological Studies><Epidemiology Research><Fetus><First Pregnancy Trimester><First Trimester><Funding><Future><Gestation><Grippe><Hospital Admission><Hospitalization><Hospitals><IgG><IgM><Immune response><Immunoglobulin G><Immunoglobulin M><Immunological response><Incidence><Income><India><Infection><Infectious Disease Pathway><Infectious Diseases><Infectious Disorder><Inflammatory><Influenza><Intensive Care><Investigation><Joints><LMIC><Laboratories><Late pregnancy><Life><Low-resource area><Low-resource community><Low-resource environment><Low-resource region><Low-resource setting><Mainland China><Maternal Mortality><Mediating><Mediator><Mothers><NICHD><National Institute of Child Health and Human Development><National Institute of Children's Health and Human Development><Neonatal><Newborn Infant><Newborns><Observation research><Observation study><Observational Study><Observational research><Obstetrics><Outcome><Parturition><Pattern><Perinatal Epidemiology><Perinatal Mortalities><Perinatal lethality><Perinatal mortality demographics><Polymerase Chain Reaction><Position><Positioning Attribute><Postpartum Period><Pre-Eclampsia><Preeclampsia><Pregnancy><Pregnancy Toxemias><Pregnancy loss><Pregnant Women><Premature Birth><Premature Labor><Premature Obstetric Labor><Prematurely delivering><Preparedness><Preterm Birth><Preterm Labor><Prevalence><Prevention><Proteinuria-Edema-Hypertension Gestosis><Province><Public Health><Publications><Readiness><Reporting><Research Specimen><Resource-constrained area><Resource-constrained community><Resource-constrained environment><Resource-constrained region><Resource-constrained setting><Resource-limited area><Resource-limited community><Resource-limited environment><Resource-limited region><Resource-limited setting><Resource-poor area><Resource-poor community><Resource-poor environment><Resource-poor region><Resource-poor setting><Respiratory Signs and Symptoms><Reverse Transcription><Risk><Risk Factors><SARS corona virus 2><SARS-CO-V2><SARS-COVID-2><SARS-CoV-2><SARS-CoV-2 disease severity><SARS-CoV-2 infected patient><SARS-CoV-2 infection><SARS-CoV-2 patient><SARS-CoV-2 positive patient><SARS-CoV-2 severity><SARS-CoV2><SARS-CoV2 infection><SARS-associated corona virus 2><SARS-associated coronavirus 2><SARS-coronavirus-2><SARS-related corona virus 2><SARS-related coronavirus 2><SARSCoV2><Scientific Publication><Severe Acute Respiratory Coronavirus 2><Severe Acute Respiratory Distress Syndrome CoV 2><Severe Acute Respiratory Distress Syndrome Corona Virus 2><Severe Acute Respiratory Distress Syndrome Coronavirus 2><Severe Acute Respiratory Syndrome CoV 2><Severe Acute Respiratory Syndrome-associated coronavirus 2><Severe Acute Respiratory Syndrome-related coronavirus 2><Severe acute respiratory syndrome associated corona virus 2><Severe acute respiratory syndrome coronavirus 2><Severe acute respiratory syndrome coronavirus 2 infection><Severe acute respiratory syndrome related corona virus 2><Severities><Site><Specimen><Spottings><Symptoms><Tablets><Testing><Time><United States Centers for Disease Control><United States Centers for Disease Control and Prevention><Update><Vaccination><Vaccines><Visit><Woman><Wuhan coronavirus><active followup><airway symptom><antenatal care><asymptomatic COVID-19><asymptomatic COVID19><asymptomatic coronavirus disease 2019><at-risk pregnancies><bio-markers><biobank><biologic marker><biomarker><biorepository><breakthrough infection><cohort><corona virus disease><corona virus disease 2019><coronavirus disease><coronavirus disease 2019><coronavirus disease 2019 consequence><coronavirus disease 2019 disease severity><coronavirus disease 2019 effect><coronavirus disease 2019 impact><coronavirus disease 2019 infected patient><coronavirus disease 2019 infection><coronavirus disease 2019 patient><coronavirus disease 2019 positive patient><coronavirus disease 2019 risk><coronavirus disease 2019 risk factor><coronavirus disease 2019 severity><coronavirus disease 2019 virus><coronavirus disease infected patient><coronavirus disease patient><coronavirus disease positive patient><coronavirus disease severity><coronavirus disease-19><coronavirus disease-19 impact><coronavirus disease-19 patient><coronavirus disease-19 virus><coronavirus infectious disease-19><coronavirus patient><cytokine><enroll><epidemiologic investigation><epidemiology study><expectant mother><expecting mother><experience><fetal><flu infection><flu virus infection><follow up><follow-up><followed up><followup><hCoV19><host response><immune system response><immunoresponse><incomes><infected with COVID-19><infected with COVID19><infected with SARS-CoV-2><infected with SARS-CoV2><infected with coronavirus disease 2019><infected with flu><infected with flu virus><infected with influenza><infected with influenza virus><infected with severe acute respiratory syndrome coronavirus 2><influenza infection><influenza virus infection><kids><low and middle-income countries><maternal death><maternal outcome><maternal risk><mortality><mother outcome><nCoV2><nasopharyngeal swab><neonate><newborn child><newborn children><offspring><patient infected with COVID><patient infected with COVID-19><patient infected with SARS-CoV-2><patient infected with coronavirus disease><patient infected with coronavirus disease 2019><patient infected with severe acute respiratory syndrome coronavirus 2><patient with COVID><patient with COVID-19><patient with COVID19><patient with SARS-CoV-2><patient with coronavirus disease><patient with coronavirus disease 2019><patient with severe acute respiratory distress syndrome coronavirus 2><perinatal deaths><perinatal outcomes><post-partum><pre-eclamptic><pregnancy toxemia/hypertension><pregnant mothers><premature childbirth><premature delivery><preterm delivery><primary outcome><recruit><respiratory infection virus><respiratory symptom><respiratory virus><risk associated with COVID-19><risk factor associated with COVID-19><risk factor related to COVID-19><risk related to COVID-19><seasonal flu><seasonal influenza><secondary analysis><severe acute respiratory syndrome coronavirus 2 disease severity><severe acute respiratory syndrome coronavirus 2 infected patient><severe acute respiratory syndrome coronavirus 2 patient><severe acute respiratory syndrome coronavirus 2 positive patient><severe acute respiratory syndrome coronavirus 2 severity><stillbirth><stillborn><symptomatic COVID-19><symptomatic COVID19><symptomatic coronavirus disease 2019><ultrasound><variants of concern><youngster>