Understanding health outcomes in patients with COVID-19 and influenza
Patient-Reported Outcomes Associated With COVID-19 and Influenza: A Prospective Survey Study on Outpatient Symptomatic Adults With Test-Confirmed Illness in the United States
This study is trying to understand how COVID-19 and influenza affect people's health and symptoms by collecting information from adults about their experiences and vaccine history over six months.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 999 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Pfizer Industry-sponsored |
| Locations | 1 site (Woonsocket, Rhode Island) |
| Trial ID | NCT05160636 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the health-related outcomes and symptoms of individuals diagnosed with COVID-19 or influenza. Participants aged 18 and older will be enrolled based on confirmed test results and reported symptoms. Over a six-month period, the study will collect data through questionnaires regarding their health status and vaccine history. The study will analyze outcomes separately for COVID-19 and influenza cohorts, focusing on patient-reported outcomes and the impact of COVID-19 vaccines.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have tested positive for COVID-19 or influenza and reported at least one symptom.
Not a fit: Patients who have not reported any symptoms or do not have a confirmed diagnosis of COVID-19 or influenza will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the health impacts of COVID-19 and influenza, potentially guiding better patient care and treatment strategies.
How similar studies have performed: Other studies have successfully explored patient-reported outcomes in similar contexts, indicating a promising approach to understanding the health impacts of viral infections.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Woonsocket, Rhode Island
- CVS Health — Woonsocket, Rhode Island, United States (Recruiting)
Study contacts
- Study coordinator: Pfizer CT.gov Call Center
- Email: ClinicalTrials.gov_Inquiries@pfizer.com
- Phone: 1-800-718-1021
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.