Results
Publications and Presentations
Research protocol design and implementation of a hybrid no-touch and low-touch prospective observational study during the COVID-19 public health emergency: the VISION study
Becky Straub, Katie R Mollan, Jessica R Keys, Chanhwa Lee, Ronald Swanstrom, Lakshmanane Premkumar, Timothy P Sheahan, Shuntai Zhou, William A Fischer, David A Wohl – Research protocol design and implementation of a hybrid no-touch and low-touch prospective observational study during the COVID-19 public health emergency: the VISION study: BMJ Public Health 2025;3:e002796.
Brief Summary/Conclusions: Overall, the hybrid online/in-person study design is a cost-effective, safe and rapid method to gain large amounts of data during an infectious disease outbreak. Synthesising the online cohort with a subset of biospecimen collection provides rich and complementary data to the questionnaires and the creation of a biorepository of samples for planned and future analyses. This and similar study designs, plus integrating the lessons learnt during the implementation of the VISION study, can inform the development of future clinical health research investigations under the challenges of an infectious disease emergency
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Nirmatrelvir-ritonavir (Paxlovid) Initiation Timing and Completion During Acute COVID-19
Ning Zhang, Jessie K. Edwards, Katie R. Mollan, Stephen R. Cole, Justin Lessler, Bonnie E. Shook-Sa, William A. Fischer, David A. Wohl. Nirmatrelvir-ritonavir (Paxlovid) Initiation Timing and Completion During Acute COVID-19. Society for Epidemiologic Research Conference 2025. Boston, MA [Poster]
Brief Summary/Conclusions Unvaccinated and historically marginalized groups were associated with lower NMV/r (Paxlovid) use.
Background The oral antiviral Nirmatrelvir-ritonavir (Paxlovid, NMV/r) is effective in treating COVID-19 when initiated within 5 days of symptom onset and continued for 5 days in high-risk individuals, but the real-world timing of NMV/r initiation and discontinuation have not been well described.
Methods Within a large prospective, observational study of people in North Carolina with acute COVID-19, we characterized patterns in NMV/r use among symptomatic individuals who tested positive for SARS-CoV-2 within 7 days of study entry between October 2022 and March 2024. We presented the probability of initiating NMV/r from 0 to 14 days after symptom onset and the probability of remaining on NMV/r at 0 to 6 days after initiation, using inverse probability censoring weighted Kaplan-Meier curves. Analyses were conducted overall and stratified by age, sex at birth, self-reported race, ethnicity, vaccination recency, prior infection(s), residential urbanicity, and risk for progression to severe disease. The average time to NMV/r initiation and discontinuation were reported by individual characteristics.
Results Among 3,141 symptomatic participants, the median age was 47 (IQR: 35, 61); 39% received their last SARS-CoV-2 vaccine within the prior 6 months, and 57% were experiencing their first known infection. The estimated probability of initiating NMV/r within 5 days of symptom onset was 0.43 (95% CI: 0.41, 0.44). Participants less likely to initiate NMV/r within 5 days included those who were younger (<65 years of age), female, non-white, Hispanic/Latinx, unvaccinated, or had 3+ prior infections (Figure). Among the 1,243 NMV/r recipients, 7.9% did not complete treatment, and the estimated probability of taking >6 days to finish the full course was 0.10 (95% CI: 0.08, 0.12). The probability of premature discontinuation was similar across groups defined by baseline covariates.
Conclusions Unvaccinated and historically marginalized groups were associated with lower NMV/r use.
Acute symptoms and return of pre-Covid19 health among vaccinated adults with a SARS-CoV2 infection between 2022-2024
Katie Mollan, Ning Zhang, Jessica R. Keys, Danyu Lin, Becky Straub, David Wohl, William Fischer. Acute symptoms and return of pre-Covid19 health among vaccinated adults with a SARS-CoV2 infection between 2022-2024. Society for Epidemiologic Research Conference 2025. Boston, MA [Oral Presentation]
Brief Summary/Conclusions Most vaccinated adults had not returned to pre-Covid19 health at 14 days after Covid19 symptom onset. During the acute phase of Covid19, those with hybrid immunity (i.e., both vaccination and prior infection) were more likely to have return of pre-Covid19 health.
Background: Acute Covid19 symptom experiences and predictors of rapid return to health among non-hospitalized adults remain of great interest. We investigated host and disease-associated predictors of return to pre-Covid19 health.
Methods: The VISION study is a prospective observational cohort of adults in North Carolina who tested SARS-CoV2 positive ≤7 days before online study enrollment (accrual period: Oct 2022-Mar2024). This analysis includes adults who enrolled 0-7 days after symptom onset and were previously
vaccinated; unvaccinated adults were excluded due to sample size limitations. Self-reported Covid19 symptoms and return of pre-Covid19 health were collected daily for 14 days. We estimated the probability of experiencing pre-Covid19 health at days 5-14 after symptom onset using a logistic
regression model fit with generalized estimating equations; days since symptom onset was fit via 9 indicators. In our model, we accounted for age (restricted cubic spline), biological sex, race-ethnicity, comorbidities, body mass index, vaccine recency (≤6 vs. >6 months ago), prior infection (0, 1+), and oral SARS-CoV2 medication use.
Results: 2,545 vaccinated adults were eligible for analysis. At baseline, median (IQR) age was 47 (36, 62) years, 74% were women, 43% had prior infection(s), and 58% were vaccinated more than 6 months ago. Within 5 days of symptom onset, 52% started nirmatrelvir-ritonavir or molnupiravir. Return to pre-Covid19 health was reported by 19.6% (95% CI: 18.1-21.1%) at day 7 and 45.1% (43.1-47.0%) at day 14 after symptom onset. Key predictors of pre-Covid19 health during the acute period included days since symptom onset, age, sex, prior infection, and vaccine recency (Figure not included in the online summary).
Conclusions: Most vaccinated adults had not returned to pre-Covid19 health at 14 days after
Covid19 symptom onset. During the acute phase of Covid19, those with hybrid immunity (i.e., both
vaccination and prior infection) were more likely to have return of pre-Covid19 health.
VISION Study – Accrual Data
The data below includes all participants who enrolled in the VISION study and had their identities verified. This information depicted is from the entry visit. The information below is current as of March 2024.
Total Enrollment
This line graph depicts total enrollment since the opening of the study in October 2022. Current enrollment as of March 2024 is 3,227. 3,126 are enrolled with a recent infection and 101 participants are enrolled as a rebounder.
Enrollment by County
This map of North Carolina counties depicts the number of enrollments across the state by zipcode. The darker blue areas have a higher total number of enrollments than the lighter blue areas. Most enrollments are in the Triangle with about 80 counties having at least one enrollment.
Sex at Birth
This pie chart depicts the percentage of the total number of study participants enrolled who were born female and born male. 74% were born female and 26% were born male. The total number of participants included in this analysis is 3,226.
Gender Identity
This pie chart depicts the percentage of the total number of study participants enrolled and their current gender identity. 72% female; 26% male, 2% Other. The total number of participants included in this analysis is 3,227.
Other includes: non-binary, other sex, prefer not to answer, transgender female and transgender male
Age at Enrollment
This bar chart depicts the number of study participants enrolled and their age ranges. 15% 18-30 years old, 23% 31-40 years old, 20% 41-50 years old, 17% 51-60 years old, 16% 61-70 years old, 9% 71-90 years old
Race
This pie chart depicts the percentage of the total number of study participants enrolled and their race. <1% American Indian or Alaska Native, 3% Asian, 9% Black or African American, 2% Other, <1% Pacific Islander, <1% Prefer not to answer, 3% Two or more races, 82% White. The total number of participants included in this analysis is 3,227.
Ethnicity
This pie chart depicts the percentage of the total number of study participants enrolled and their ethnicity. 6% Hispanic, 94% Not Hispanic, <1% Prefer not to answer. The total number of participants included in this analysis is 3,227.
Number of COVID-19 Vaccines at Entry
This bar chart depicts the number of study participants who endorse receiving between 0-6 vaccines at entry. 5% had no vaccines, 3% 1 vaccine, 17% vaccines, 24% 3 vaccines, 27% 4 vaccines, 19% 5 vaccines, 5% 6 vaccines, 1 person with 9 vaccines and 1 person with 10 or more vaccines.
Long COVID at Entry
This pie chart depicts the percentage of the total number of study participants enrolled and if they had Long COVID at entry. Please note that this question was introduced in January 2023 and the percentages shown are for participants who enrolled after this time point. 88% No, 12% Yes. The total number of participants included in this analysis is 1,183.
COVID-19 Oral Treatment at Entry
This pie chart depicts the percentage of the total number of study participants enrolled and if they endorsed taking Paxlovid, Molnupiravir or No Treatment at entry. No treatment is defined as not taking either Molnupiravir or Paxlovid. 5% Molnupiravir, 42% Paxlovid, 53% No Treatment. The total number of participants included in this analysis is 3,215.