# Progesterone induced immune modulation during pregnancy – supplemental research in COVID-19

> **NIH NIH R01** · CINCINNATI CHILDRENS HOSP MED CTR · 2021 · $488,752

## Abstract

Project Summary: Despite pandemic spread of the novel coronavirus, COVID-19, significant knowledge gaps
remain especially for Center for Disease Control designated high risk populations such as pregnant women. Of
high clinical importance is the susceptibility of pregnant women to infection, the direct risk to the mother and the
indirect impact of disease severity (including preterm delivery and fetal death) on the pregnancy. While much
research is being pursued from translational research to intervention trials for COVID-19, pregnant women are
almost universally excluded from intervention and observational trials. Research in pregnant women is of the
highest priority. The ability to understand which pregnant women are at risk for severe COVID-19 disease, weeks
if not months prior to clinical symptomatology, could provide novel and important windows for preventative
interventions to limit maternal morbidity and mortality. Additionally, if clinical data emerges that the majority of
pregnant women may actually be more tolerant of SARS-CoV-2 compared to other respiratory viruses,
understanding the immunological changes of pregnancy may provide insights as to ways to modulate disease
risk in non-pregnant populations. To address all of these gaps in knowledge, large maternal cohorts with
biospecimens and detailed phenotyping in areas of high prevalence of COVID-19 are required. The established
investigative team and research infrastructure for two active maternal cohorts designed for prospective analysis
of maternal immunity during pregnancy (R01-A1145840) can now be leveraged to investigate deep immune
phenotyping of pregnant women prior to acquisition of COVID-19. We will be able to investigate how different
immune phenotypes predict COVID-19 infection in pregnant women. Complementing the existing expertise in
perinatology and immunology for the parent RO1, this study add the immunology and virology expertise at the
University of Pennsylvania. We propose to investigate the following three scientifically important aims: 1) whether
maternal immune profiles are associated with acquisition and severity of COVID19 in pregnant women; 2)
whether immune profiles in pregnant women with active COVID19 are similar to non-pregnant women with similar
disease severity and 3) whether immune profiles in the 2nd trimester of pregnancy are associated with adverse
reproductive outcomes. All women enrolled will have extensive metadata collected with adjudication of COIVD-
19 status and severity as well as detailed clinical phenotyping of obstetrical outcomes. Deep immune
phenotyping will provide innovative and rigorous investigation of innate and adaptive immune states during
pregnancy and will be interrogated regarding their association with COVID19 phenotypes. We will also
investigate the presence of maternal antibodies (IgG and IgM against SARS-CoV-2) at the same time point as
immune profiling. We have the necessary expertise, the research infrastructure and the pati...

## Key facts

- **NIH application ID:** 10200397
- **Project number:** 3R01AI145840-02S1
- **Recipient organization:** CINCINNATI CHILDRENS HOSP MED CTR
- **Principal Investigator:** Sing Sing Way
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $488,752
- **Award type:** 3
- **Project period:** 2021-02-04 → 2023-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10200397

## Citation

> US National Institutes of Health, RePORTER application 10200397, Progesterone induced immune modulation during pregnancy – supplemental research in COVID-19 (3R01AI145840-02S1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10200397. Licensed CC0.

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