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OpenTrials
Completed

NCT Number: NCT04962477

Understanding Host-pathogen Interaction in the Respiratory Mucosa During Pregnancy

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.

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Key information

Conditions

Pregnancy Related Inflammation Innate Inflammatory Response Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nasal brush sampling

Other

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.

Primary outcomes

  1. Expression of viral entry factors

    Time frame: Dec 2021

Secondary outcomes

  1. Expression of genes involved in innate immune response and host-pathogen interaction

    Time frame: Dec 2021

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 15, 2021
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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