Actively Recruiting
Dissecting Human Immune Responses to Infection With Influenza or SARS-CoV-2
Led by Washington University School of Medicine · Updated on 2026-03-12
300
Participants Needed
1
Research Sites
238 weeks
Total Duration
On this page
Sponsors
W
Washington University School of Medicine
Lead Sponsor
N
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the virus-specific immune response in people who are symptomatic with confirmed influenza or COVID-19. We will study the immune response of people who have and who have not been vaccinated with the seasonal influenza and COVID-19 vaccines within the past year. All participants will have data collected and blood, saliva, and nasal swabs performed at five separate visits; 1) at study enrollment, 2) on study day 7, 3) on or between study days 10 to 28, 4) on study day 90, and 5) on study day 180. For participants who agree to the optional sub-study, bronchoscopy with bronchoalveolar lavage (BAL) and endobronchial biopsy (EBBx) will be performed once between study days 10 and 28 and once at study day 180. As part of the bronchoscopy procedure, two chest x-rays will be performed. The bronchoscopy and chest x-ray procedures are not required for participation in the study.
CONDITIONS
Official Title
Dissecting Human Immune Responses to Infection With Influenza or SARS-CoV-2
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have acute, symptomatic influenza or SARS-CoV-2 infection confirmed by an approved test and be enrolled while still symptomatic or within 72 hours after symptoms end.
- Uninfected control participants must have received an FDA-approved influenza and/or SARS-CoV-2 vaccine within the past 12 months and not had a documented infection since then.
- Participants must be able to understand and give written informed consent.
- Participants must be male or female between 18 and 60 years old.
- Participants must be in stable health based on medical history and physical exam.
You will not qualify if you...
- Co-infection with any other respiratory virus besides the confirmed influenza or SARS-CoV-2 infection.
- Severe illness expected to require hospitalization for the current infection.
- Current or past diagnosis of an immunocompromising condition.
- Use of systemic immunosuppressants or immune-modifying drugs for more than 14 days within 6 months before screening or expected need for such treatment during the study.
- Current acute or unstable chronic disease needing medical or surgical care or hospitalization.
- Known chronic pulmonary, cardiovascular, renal, hepatic, hematologic, or metabolic disorders except treated hypertension.
- Chronic neurologic or neurodevelopmental conditions causing weakness, excluding chronic back pain or migraines.
- Active cancer diagnosis not in remission for at least 1 year, except isolated basal or squamous cell skin cancers.
- History of excessive alcohol use, drug abuse, psychiatric, social, or occupational conditions that may affect compliance.
- Body Mass Index over 40.
- Pregnant or nursing women or those planning pregnancy during the study.
- Blood, blood product, or bone marrow donation within 30 days before entry or planned donation during or 30 days after the study.
- Participation in another clinical trial with investigational agents unless only in follow-up and last dose was over 30 days or 5 half-lives ago.
- Any condition that may interfere with safe and proper study conduct.
- For bronchoscopy: coagulopathy, significant lung disease on day of procedure, or allergy/contraindication to anesthesia.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Washington University in Saint Louis Department of Emergency Medicine, Emergency Care Research Core
St Louis, Missouri, United States, 63110
Actively Recruiting
Research Team
J
Jamie Mills
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
5
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