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Clinical Trials/NCT04962477
NCT04962477
Completed
Not Applicable

Understanding Host-pathogen Interaction in the Respiratory Mucosa During Pregnancy

Washington University School of Medicine1 site in 1 country48 target enrollmentMarch 2, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pregnancy Related
Sponsor
Washington University School of Medicine
Enrollment
48
Locations
1
Primary Endpoint
Expression of viral entry factors
Status
Completed
Last Updated
4 months ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
March 2, 2022
End Date
September 27, 2023
Last Updated
4 months ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Arvind Palanisamy

Associate Professor of Anesthesiology, Obstetrics and Gynecology

Washington University School of Medicine

Eligibility Criteria

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)

Outcomes

Primary Outcomes

Expression of viral entry factors

Time Frame: Dec 2021

Secondary Outcomes

  • Expression of genes involved in innate immune response and host-pathogen interaction(Dec 2021)

Study Sites (1)

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