ABSTRACT
Purpose: Few studies have examined how the absolute risk of thromboembolism with COVID-19 has evolved over time across different countries. Researchers from the European Medicines Agency, Health Canada, and the United States (US) Food and Drug Administration established a collaboration to evaluate the absolute risk of arterial (ATE) and venous thromboembolism (VTE) in the 90 days after diagnosis of COVID-19 in the ambulatory (eg, outpatient, emergency department, nursing facility) setting from seven countries across North America (Canada, US) and Europe (England, Germany, Italy, Netherlands, and Spain) within periods before and during COVID-19 vaccine availability. Patients and Methods: We conducted cohort studies of patients initially diagnosed with COVID-19 in the ambulatory setting from the seven specified countries. Patients were followed for 90 days after COVID-19 diagnosis. The primary outcomes were ATE and VTE over 90 days from diagnosis date. We measured country-level estimates of 90-day absolute risk (with 95% confidence intervals) of ATE and VTE. Results: The seven cohorts included 1,061,565 patients initially diagnosed with COVID-19 in the ambulatory setting before COVID-19 vaccines were available (through November 2020). The 90-day absolute risk of ATE during this period ranged from 0.11% (0.09-0.13%) in Canada to 1.01% (0.97-1.05%) in the US, and the 90-day absolute risk of VTE ranged from 0.23% (0.21-0.26%) in Canada to 0.84% (0.80-0.89%) in England. The seven cohorts included 3,544,062 patients with COVID-19 during vaccine availability (beginning December 2020). The 90-day absolute risk of ATE during this period ranged from 0.06% (0.06-0.07%) in England to 1.04% (1.01-1.06%) in the US, and the 90-day absolute risk of VTE ranged from 0.25% (0.24-0.26%) in England to 1.02% (0.99-1.04%) in the US. Conclusion: There was heterogeneity by country in 90-day absolute risk of ATE and VTE after ambulatory COVID-19 diagnosis both before and during COVID-19 vaccine availability.
ABSTRACT
The association between the presence of detectable antibodies to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and SARS-CoV-2 reinfection is not well established. The objective of this study was to determine the association between antibody seronegativity and reinfection. METHODS: Participants in Colorado, USA, were recruited between June 15, 2020, and March 28, 2021, and encouraged to complete SARS-CoV-2 molecular ribonucleic acid (RNA) and serology testing for antibodies every 28 days for 10 months. Participants with reinfections (positive SARS-CoV-2 RNA test ≥ 90 days after the first positive RNA test) were matched to controls without reinfections by age, sex, date of the first positive RNA test, date of the last serology test, and serology test type. Using conditional logistic regression, case patients were compared to control patients on the last serologic test result, with adjustment for demographic and clinical confounders. RESULTS: The cohort (n = 4,235) included 2,033 participants with ≥ 1 positive RNA test, of whom 120 had reinfection. Among the 80 case patients who could be matched, the last serologic test was negative in 12 of the cases (15.0 %) whereas the last serologic test was negative in 77 of 1,034 (7.5 %) controls. Seronegativity (adjusted OR [aOR] 2.24; 95 % CI 1.07, 4.68), Hispanic ethnicity (aOR 1.87; 95 % 1.10, 3.18), and larger household size (aOR 1.15; 95 % 1.01, 1.30 for each additional household member) were associated with reinfection. CONCLUSIONS: Seronegative status, Hispanic ethnicity, and increasing household size were associated with reinfection. Serologic testing could be considered to reduce vaccine hesitancy in higher risk populations.