Understanding Host-pathogen Interaction in the Respiratory Mucosa During Pregnancy

Sponsor

Washington University School of Medicine (Other)

Overall Status

Recruiting

CT.gov ID

NCT04962477

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pregnancy Related Innate Inflammatory Response	Other: Nasal brush sampling

Study Design

Study Type:

Observational

Anticipated Enrollment :

30 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Understanding Host-pathogen Interaction in the Respiratory Mucosa During Pregnancy

Actual Study Start Date :

Mar 2, 2022

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Pregnant	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.
Non-pregnant	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.

Arm

Intervention/Treatment

Pregnant

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.

Non-pregnant

Other: Nasal brush sampling

Outcome Measures

Primary Outcome Measures

Expression of viral entry factors [Dec 2021]

Secondary Outcome Measures

Expression of genes involved in innate immune response and host-pathogen interaction [Dec 2021]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Washington University in St. Louis	Saint Louis	Missouri	United States	63110

Sponsors and Collaborators

Washington University School of Medicine

Investigators

Principal Investigator: Arvind Palanisamy, MD, Washington University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Arvind Palanisamy, Associate Professor of Anesthesiology, Obstetrics and Gynecology, Washington University School of Medicine

ClinicalTrials.gov Identifier:

NCT04962477

Other Study ID Numbers:

202107016

First Posted:

Jul 15, 2021

Last Update Posted:

Mar 22, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Inflammation

Study Results

No Results Posted as of Mar 22, 2022