Frequency and Severity of COVID-19 Acute Symptoms Among Symptomatic US Adults Testing Positive for SARS-CoV-2: Early 2024-2025 Respiratory Season Results of a Nationwide Study
Author(s)
Alon Yehoshua, PharmD1, Laura Lupton, MHA, MD2, Tianyan Hu, PhD1, Joseph C. Cappelleri, MPH, MS, PhD1, Meghan Gavaghan, MPH1, Santiago M. Lopez, MD1, Laura Puzniak, PhD1, Manuela Di Fusco, PhD1, Xiaowu Sun, PhD2;
1Pfizer Inc., New York, NY, USA, 2CVS Health, Woonsocket, RI, USA
1Pfizer Inc., New York, NY, USA, 2CVS Health, Woonsocket, RI, USA
Presentation Documents
OBJECTIVES: To characterize the burden of acute COVID-19 symptoms.
METHODS: Symptomatic US adults testing positive for SARS-CoV-2 at CVS Health from 10/24/2024-1/3/2025 (recruitment ongoing) (CT.gov: NCT05160636) were included. Self-reported socio-demographics, clinical characteristics and vaccination status were collected via an online survey. Prevalence of 11 CDC-based acute symptoms were self-reported by participants at enrollment (Day 1) and recalled prior to infection (pre-infection period). Symptoms severity was measured using an FDA-based 4-point scale (0=none, 1=mild, 2=moderate, 3=severe). Prevalence of any and moderate/severe individual symptoms, and total symptom counts were described and compared across time points using a paired t-test.
RESULTS: Of 118 participants, 22 (18.6%) were vaccinated with the 2024-2025 KP.2 BNT162b2 COVID-19 vaccine and 96 (81.4%) unvaccinated. Mean age was 48.9 years, 76.3% were female, 67.0% had ≥1 comorbidity. Among those vaccinated, mean (SD) time since vaccination was 71.0 (25.6) days. The most prevalent symptoms reported at enrollment were cough (99.2%), stuffy/runny nose (98.3%), and fatigue (94.9%). The symptoms most commonly reported as moderate/severe and severe at enrollment were fatigue (78.0%) and stuffy/runny nose (36.4%), respectively. Vomiting (12.7%) was less often reported at enrollment. At enrollment, the mean (SD) number of any acute symptoms was 8.6 (2.2). There was a significant increase of +6.7 in the mean number of any symptoms reported at enrollment relative to pre-infection (p<0.001). The mean (SD) number of moderate or severe symptoms reported at enrollment was 7.6 (4.3), showing an increase of +6.9 from pre-infection (p<0.001).
CONCLUSIONS: These early respiratory season results show that the burden of symptomatic COVID-19 in the US remains high in the post-pandemic period. The most frequently reported symptoms were cough, stuffy nose, and fatigue. The findings of this study highlight the importance of implementing and promoting effective preventative strategies, including updated COVID-19 vaccination, to mitigate both individual and public health impacts.
METHODS: Symptomatic US adults testing positive for SARS-CoV-2 at CVS Health from 10/24/2024-1/3/2025 (recruitment ongoing) (CT.gov: NCT05160636) were included. Self-reported socio-demographics, clinical characteristics and vaccination status were collected via an online survey. Prevalence of 11 CDC-based acute symptoms were self-reported by participants at enrollment (Day 1) and recalled prior to infection (pre-infection period). Symptoms severity was measured using an FDA-based 4-point scale (0=none, 1=mild, 2=moderate, 3=severe). Prevalence of any and moderate/severe individual symptoms, and total symptom counts were described and compared across time points using a paired t-test.
RESULTS: Of 118 participants, 22 (18.6%) were vaccinated with the 2024-2025 KP.2 BNT162b2 COVID-19 vaccine and 96 (81.4%) unvaccinated. Mean age was 48.9 years, 76.3% were female, 67.0% had ≥1 comorbidity. Among those vaccinated, mean (SD) time since vaccination was 71.0 (25.6) days. The most prevalent symptoms reported at enrollment were cough (99.2%), stuffy/runny nose (98.3%), and fatigue (94.9%). The symptoms most commonly reported as moderate/severe and severe at enrollment were fatigue (78.0%) and stuffy/runny nose (36.4%), respectively. Vomiting (12.7%) was less often reported at enrollment. At enrollment, the mean (SD) number of any acute symptoms was 8.6 (2.2). There was a significant increase of +6.7 in the mean number of any symptoms reported at enrollment relative to pre-infection (p<0.001). The mean (SD) number of moderate or severe symptoms reported at enrollment was 7.6 (4.3), showing an increase of +6.9 from pre-infection (p<0.001).
CONCLUSIONS: These early respiratory season results show that the burden of symptomatic COVID-19 in the US remains high in the post-pandemic period. The most frequently reported symptoms were cough, stuffy nose, and fatigue. The findings of this study highlight the importance of implementing and promoting effective preventative strategies, including updated COVID-19 vaccination, to mitigate both individual and public health impacts.
Conference/Value in Health Info
2025-05, ISPOR 2025, Montréal, Quebec, CA
Value in Health, Volume 28, Issue S1
Code
PCR156
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
SDC: Infectious Disease (non-vaccine)