Pfizer Inc engaged CVS Health Clinical Trial Services to conduct a prospective nationwide non-interventional study¹ examining symptoms, health-related quality of life and work productivity and activity impairment in symptomatic patients who tested positive for COVID-19 via reverse transcription-polymerase chain reaction (RT-PCR) at CVS Health locations in the US. Most CVS Health COVID-19 test results are reported within three days of a positive test², allowing for quick patient outreach and reducing potential recall bias. Subjects were enrolled in this study within three days of their positive test result, if reporting ≥1 symptom.. They were then followed over time to assess quality of life at regular intervals via validated patient-reported outcome measures (WPAI-GH, EQ-5D-5L) along with self-reported continued symptoms. Leveraging the reach of CVS Health and a streamlined e-consent process enabled the study to enroll quickly, with 537 subjects enrolled within one day of recruitment, and 77% of subjects remaining engaged at one month of follow-up.

One of the first studies of its kind, our study found that at one month of follow-up, statistically significant and clinically meaningful differences in outcomes were observed compared with baseline between vaccinated and unvaccinated groups. The EQ-5D Visual Analogue Scale (VAS) and Utility Index (UI) scores dropped in both cohorts and did not return to pre-COVID-19 levels by one month of follow-up. Individuals vaccinated with BNT162b2 reported lower prevalence and fewer symptoms both at the time of their positive test and at one month of follow-up in comparison with unvaccinated individuals. Overall, our study, published in the Journal of Patient-Reported Outcomes found that COVID-19 negatively impacted health-related quality of life (HRQoL) and work productivity among mildly symptomatic outpatient subjects³. Individuals vaccinated with BNT162b2 were less impacted by COVID-19 and recovered faster than unvaccinated individuals.

Sponsor: CVS Clinical Trial Services