Understanding Host-pathogen Interaction in the Respiratory Mucosa During Pregnancy

Pregnancy Related Clinical Trial

Official title:

Understanding Host-pathogen Interaction in the Respiratory Mucosa During Pregnancy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04962477
• Other study ID #: 202107016
• Status: Active, not recruiting
• Start date: March 2, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: February 2024
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: June 30, 2024
• Est. primary completion date: September 27, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammation
• Pregnancy Related

Intervention

Other:
• Nasal brush sampling
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.

Locations

Country	Name	City	State
United States	Washington University in St. Louis	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Expression of viral entry factors		Dec 2021
Secondary	Expression of genes involved in innate immune response and host-pathogen interaction		Dec 2021