A Study to Look at the Health Outcomes of Patients With COVID-19 and Influenza (NCT05160636) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
A Study to Look at the Health Outcomes of Patients With COVID-19 and Influenza
United States999 participantsStarted 2022-01-31
Plain-language summary
The main purpose of this study is to understand:
* the symptoms of COVID-19 or influenza- health-related outcomes of people with COVID-19 or influenza (influenza only included in updated study analyses)
* the potential effects of COVID-19 vaccines in people with COVID-19
This study will enroll participants who are:
* 18 years or older
* reported to have symptoms with tests that have confirmed illness. The tests can be taken at any of CVS pharmacy COVID-19 or influenza test sites.
The study will collect vaccine history information from participants who are ready to take part in the study. Participant will be emailed a form with questions about their health related to COVID-19 or influenza during multiple follow-ups over a 6-month period.
Who can participate
Age range
18 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:
* Age 18 or older
* Self-reported at least one symptom in the CVS Health pre-test screening questionnaire
* Positive result reported from diagnostic test for COVID-19 (or influenza in updated analysis)
* Evidence of a signed and dated informed consent through electronic consent process indicating that the participant has been informed of all pertinent aspects of the study
* Able to complete the questionnaires by themselves in English or Spanish
Exclusion Criteria:
\- No symptoms reported in the study screening questionnaire
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.
1Since this study is observational and tracking health outcomes like quality of life and work productivity rather than testing a new treatment, would participating change anything about how I'm actually treated for my COVID-19 or influenza?
2This trial is no longer recruiting new participants — does that mean there's any chance I could still be considered, or should we focus entirely on other options?
3The study uses tools like the EQ-5D-5L and WPAI questionnaires to measure how illness affects my daily life and ability to work — how time-consuming would filling these out be, and is that something I'd need to do repeatedly over time?
4Since this is listed as Phase NA, meaning it's not testing a new drug or intervention, what would be the actual benefit to me personally versus contributing data that might help future patients?
5Given that this study tracks outcomes for both COVID-19 and influenza, does my specific diagnosis affect whether this kind of observational research is even relevant to the treatment decisions we're considering together?
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
Change in Health Related Quality of Life (HRQoL) using EQ-5D-5L