Understanding Host-pathogen Interaction in the Respiratory Mucosa During Pregnancy

Active, not recruiting

• Conditions: Pregnancy Related; Innate Inflammatory Response
• Interventions: Other: Nasal brush sampling

• Registration Number: NCT04962477
• Lead Sponsor: Washington University School of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-02
• Study First Submitted QC: 2021-07-13
• Study First Posted: 2021-07-15
• Study Start: 2022-03-02
• Primary Completion: 2023-09-27
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-29
• Last Update Posted: 2024-03-04
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-pregnant	Nasal brush sampling	-
Pregnant	Nasal brush sampling	-

Primary Outcome Measures

Name	Time	Method
Expression of viral entry factors	Dec 2021

Secondary Outcome Measures

Name	Time	Method
Expression of genes involved in innate immune response and host-pathogen interaction	Dec 2021

Trial Locations

Locations (1)

Washington University in St. Louis; 🇺🇸 Saint Louis, Missouri, United States