Dissecting Human Immune Responses to Infection With Influenza or SARS-CoV-2 (NCT06848309) | Clinical Trial Compass
RecruitingNot Applicable
Dissecting Human Immune Responses to Infection With Influenza or SARS-CoV-2
United States300 participantsStarted 2025-03-07
Plain-language summary
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.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participants must have presented with acute, symptomatic seasonal influenza or SARS-CoV-2 infection proven by an approved CLIA certified test and be enrolled in study while still symptomatic or within 72 hours of the resolution of viral respiratory illness symptoms.
* Alternatively, uninfected participants in the control cohort must have received an FDA-approved seasonal influenza and/or SARS-CoV-2 vaccine within the past 12 months and not experienced a documented influenza or SARS-CoV-2 infection since receiving that most recent vaccine dose.
* Participants must be able to understand and provide full written informed consent.
* Participants must be male or female between the ages of 18 and 60.
* Participants must be in stable health, as determined by medical history and targeted physical exam related to that history.
Exclusion Criteria:
* Co-infection with any respiratory virus in addition to the index influenza or SARS-CoV-2 infection on a multi-plex viral testing panel.
* Severe illness with anticipated need for hospitalization for the index infection.
* Current or previous diagnosis of an immunocompromising condition.
* Receipt of systemic immunosuppressants or immune-modifying drugs for \> 14 days in total within 6 months prior to screening or is anticipating the need for immunosuppressive treatment at any time during study participation.
* Current symptomatic acute or unstable chronic disease requiring medical or surgical care, to include signif…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study is observational and seems focused on measuring immune responses in people who already have influenza or COVID-19 — does that mean there's no experimental treatment involved, and what exactly would be asked of me if I participated?
2Since the trial is collecting samples from my blood, saliva, nose, and lower airways, how many visits or sample collections would that require, and are any of those procedures uncomfortable or carry any risk?
3The study is tracking IgG and IgA antibody levels over time after infection — would my doctor receive any of my individual results, or is the data only used for research purposes?
4Given that this is a Phase N/A observational study rather than a treatment trial, how does participating here compare to just focusing on my standard care and recovery from influenza or COVID-19?
5Are there specific eligibility criteria — like how recently I was infected or how sick I currently am — that my doctor would need to review before considering whether this study might even be relevant for me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To measure the difference in the concentration of systemic and mucosal influenza-specific or SARS-CoV-2-specific IgG and IgA in the blood, saliva, nasopharynx, and lower airways and how these concentrations change over time following acute infection
Timeframe: At study enrollment (day 0) which will occur during active symptomatic viral infection and at 6 months after study enrollment