Understanding Host-pathogen Interaction in the Respiratory Mucosa During Pregnancy

Study Overview
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Brief Summary
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The clinical presentation of the ongoing coronavirus disease-19 (COVID-19) pandemic in pregnant women is unique with more asymptomatic infection, higher morbidity when symptomatic, yet without a difference in mortality rate. This is strikingly different from the high mortality observed during the past influenza A pandemics. Though both influenza A virus (IAV) and SARS-CoV-2 are single-stranded RNA viruses, the exquisite vulnerability of pregnant women to influenza A but not COVID-19 remains a mystery. Our objective, therefore, is to determine the mechanisms that predispose pregnant women to severe influenza A but confer protection against SARS-CoV-2 infection by examining the viral entry factors and innate immune response mechanisms in the nasal epithelium of pregnant vs. non-pregnant age-matched women.

Official Title
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Understanding Host-pathogen Interaction in the Respiratory Mucosa During Pregnancy

Conditions
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Pregnancy Related, Innate Inflammatory Response

Intervention / Treatment
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* Other: Nasal brush sampling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy, uncomplicated pregnant subjects in the third trimester ((≥ 28 ≤ 41 weeks' gestation) Healthy non-pregnant adult female volunteers between the ages of 18 - 45 years. Between 18-45 years old Able to provide consent Exclusion Criteria: Patients in labor Critically ill patients needing intubation and mechanical ventilation Patients with fever or influenza-like illness H/o epistaxis or rhinosinusitis Nasal polyposis and deviated nasal septum Preeclampsia and chronic hypertension Use of anti-hypertensives Ongoing seasonal allergy H/o asthma Recent recovery from SARS-CoV-2 or influenza A infection (≤ 4 weeks) Recent receipt of either COVID-19 or influenza A vaccine (≤ 4 weeks) Use of immunosuppressive medications Use of inhaled corticosteroids Use of hormonal contraceptives in non-pregnant population Allergy to local anesthetic

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnant<br> | Other: Nasal brush sampling<br>* Nasal brush samples will be collected from the inferior turbinate using standardized techniques after local anesthetic application. After clearing the mucus from the nasal cavity by asking the patient to blow their nostrils twice followed by local anesthetic spray application, nasal brush samples will be collected from the inferior turbinate of each nostril with dedicated soft cytology brushes and pooled together for molecular biological experiments. Simultaneously, 10 mL of peripheral blood will be collected for immunophenotyping.<br>|
| Non-pregnant<br> | Other: Nasal brush sampling<br>* Nasal brush samples will be collected from the inferior turbinate using standardized techniques after local anesthetic application. After clearing the mucus from the nasal cavity by asking the patient to blow their nostrils twice followed by local anesthetic spray application, nasal brush samples will be collected from the inferior turbinate of each nostril with dedicated soft cytology brushes and pooled together for molecular biological experiments. Simultaneously, 10 mL of peripheral blood will be collected for immunophenotyping.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Expression of viral entry factors |  | Dec 2021 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Expression of genes involved in innate immune response and host-pathogen interaction |  | Dec 2021 |