# Influenza & COVID Obstetric and Perinatal Epidemiology Study in India

> **NIH NIH R01** · BOSTON UNIVERSITY MEDICAL CAMPUS · 2024 · $508,025

## Abstract

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 t...

## Key facts

- **NIH application ID:** 10899508
- **Project number:** 5R01HD107054-03
- **Recipient organization:** BOSTON UNIVERSITY MEDICAL CAMPUS
- **Principal Investigator:** Patricia L Hibberd
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $508,025
- **Award type:** 5
- **Project period:** 2022-09-23 → 2027-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10899508

## Citation

> US National Institutes of Health, RePORTER application 10899508, Influenza & COVID Obstetric and Perinatal Epidemiology Study in India (5R01HD107054-03). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10899508. Licensed CC0.

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