ABSTRACT
Background: Concerns emerged for the management of intramuscular (IM) injections for COVID-19 vaccines in patients with therapeutic anticoagulation. Aim(s): The aim of the study was to evaluate the risk of bleeding events following IM vaccination in patients under therapeutic anticoagulation Methods: We first performed a French multicentre prospective study including patient treated by anticoagulant therapy for venous thromboembolism between May 2021 and September 2021. Consecutive patients were asked to report bleeding events at the site of COVID-19 vaccine injection during follow-up. We next performed a request in the French national pharmacovigilance database to identify cases of bleeding events at the site of injections following COVID-19 vaccine in patients under therapeutic anticoagulation between December, 27th, 2020 and June, 30th, 2021. Result(s): Between May and September 2021, a total of 348 patients with anticoagulant therapy received 561 IM injections of COVD-19 vaccines. Median age of patients was 68.4 years and 65.2% were males. Almost all patients were treated with direct oral anticoagulant (DOAC 96.6%), 11 (3.2%) patients with vitamin K antagonist and one (0.2%) with tinzaparin. Among them, 17.9% had pressure at the injection site after the injection and 4.2% had anticoagulant dose skipping before vaccination. After IM injections, a total of 3 (0.6%) bleeding events were observed, 2 (0.4%) minor and one (0.2%) clinically relevant non-major bleeding. We next observed in the French national pharmacovigilance database a total of 13 bleeding events (all minor bleeding) at the site of injection in patients on therapeutic anticoagulation between December, 27th, 2020 and June, 30th, 2021. In France, 69,089,410 doses of COVID-19 vaccine were administered during this period. These bleeding events correspond to a spontaneous notification rate of 0.19 cases (95% CI 0.09-0.29) reported per million of doses administered. Conclusion(s): IM vaccination appears safe in patients under therapeutic anticoagulation in particular with DOAC, and may not require skipping doses.
ABSTRACT
Background: Lower risk of COVID-19 was reported in men with prostate cancer receiving androgen deprivation therapy while low levels of testosterone (T) were associated with a more severe disease and poor clinical outcomes in COVID-19 male patients (pts). In the latter case, it is unclear whether low levels of T and dihydrotestoserone (DHT) are risk factors or consequences of COVID-19. Here, we investigated T and DHT levels impact on COVID-19 severity in ambispective cohorts of symptomatic SARS-CoV-2 infected males. Methods: Both prospective (European Hospital Georges Pompidou patients, P-cohort) and retrospective (French COVID-19 cohort, REacting project, R-cohort) cohorts included male pts admitted for severe COVID-19. The P-cohort included pts admitted in a medical unit (non-ICU) or in ICU immediately (ICU-I). The R-cohort included pts admitted to a medical unit, ICU-I or to ICU secondarily (ICU-S). The size of ICU-S pts group in P-cohort was insufficient to include their data in the analysis. We collected information on pts demographics and COVID-19-related outcomes. T, DHT levels and inflammation markers were measured. Wilcoxon-Mann-Whitney test and chi2-test (or Fisher’s exact test, if appropriate) were performed. All tests were two-sided at 0.05 significance level. Results: The P-cohort included 71 pts (median age: 64 years) and the R-cohort 89 pts (median age: 62 years). The median duration between admission and measurement of hormone levels was 2 days (range: 0-16) and 0.5 days (range: 0-11) respectively. T and DHT levels were low in all pts as compared to standards and even lower in ICU pts (Table). In the R-cohort, T and DHT lowest values were observed for ICU-I pts and median values for ICU-S pts. [Formula presented] Conclusions: Low T and DHT levels were associated with the severity of the disease and the poorest clinical outcomes in males with severe COVID-19. This suggests that COVID-19 may cause a rapid and profound decrease in androgens levels and that T and DHT serum levels may be used as prognostic markers. Legal entity responsible for the study: Pr. Stéphane Oudard. Funding: Has not received any funding. Disclosure: All authors have declared no conflicts of interest.