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2.
JAMA Intern Med ; 181(10): 1306-1314, 2021 10 01.
Article in English | MEDLINE | ID: covidwho-1306626

ABSTRACT

Importance: Two mRNA-based vaccines against coronavirus disease 2019 (COVID-19) were found to be highly efficacious in phase 3 clinical trials in the US. However, patients with chronic illnesses, including cirrhosis, were excluded from clinical trials. Patients with cirrhosis have immune dysregulation that is associated with vaccine hyporesponsiveness. Objective: To study the association of receipt of the Pfizer BNT162b2 mRNA or the Moderna mRNA-1273 vaccines in patients with cirrhosis compared with a propensity-matched control group of patients at similar risk of infection and severe disease from COVID-19. Design, Setting, and Participants: We performed a retrospective cohort study of patients with cirrhosis who received at least 1 dose of a COVID-19 mRNA vaccine at the Veterans Health Administration. Patients who received at least 1 dose of the vaccine (n = 20 037) were propensity matched with 20 037 controls to assess the associations of vaccination with new COVID-19 infection and COVID-19 hospitalization and death. Exposures: Receipt of at least 1 dose of the BNT162b2 mRNA or the mRNA-1273 vaccines between December 18, 2020, and March 17, 2021. Main Outcomes and Measures: COVID-19 infection as documented by a positive result for COVID-19 by polymerase chain reaction, hospitalization, and death due to COVID-19 infection. Results: The median (interquartile range) age of the vaccinated individuals in the study cohort was 69.1 (8.4) years and 19 465 (97.2%) of the participants in each of the vaccinated and unvaccinated groups were male, consistent with a US veteran population. The mRNA-1273 vaccine was administered in 10 236 (51%) and the BNT162b2 mRNA in 9801 (49%) patients. Approximately 99.7% of patients who received the first dose of either vaccine with a follow-up of 42 days or more received a second dose. The number of COVID-19 infections in the vaccine recipients was similar to the control group in days 0 to 7, 7 to 14, 14 to 21, and 21 to 28 after the first dose. After 28 days, receipt of 1 dose of an mRNA vaccine was associated with a 64.8% reduction in COVID-19 infections and 100% protection against hospitalization or death due to COVID-19 infection. The association of reduced COVID-19 infections after the first dose was lower among patients with decompensated (50.3%) compared with compensated cirrhosis (66.8%). Receipt of a second dose was associated with a 78.6% reduction in COVID-19 infections and 100% reduction in COVID-19-related hospitalization or death after 7 days. Conclusions and Relevance: This cohort study of US veterans found that mRNA vaccine administration was associated with a delayed but modest reduction in COVID-19 infection but an excellent reduction in COVID-19-related hospitalization or death in patients with cirrhosis.


Subject(s)
COVID-19 Vaccines , COVID-19/epidemiology , COVID-19/prevention & control , Hospitalization , Liver Cirrhosis/complications , Aged , Aged, 80 and over , Female , Humans , Liver Cirrhosis/mortality , Male , Middle Aged , Propensity Score , Retrospective Studies , Survival Rate , United States , Veterans
3.
Open Forum Infect Dis ; 7(9): ofaa320, 2020 Sep.
Article in English | MEDLINE | ID: covidwho-787247

ABSTRACT

BACKGROUND: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2 ) is responsible for coronavirus disease 2019 (COVID-19), a disease that had not been previously described and for which clinicians need to rapidly adapt their daily practice. The novelty of SARS-CoV-2 produced significant gaps in harmonization of definitions, data collection, and outcome reporting to identify patients who would benefit from potential interventions. METHODS: We describe a multicenter collaboration to develop a comprehensive data collection tool for the evaluation and management of COVID-19 in hospitalized patients. The proposed tool was developed by a multidisciplinary working group of infectious disease physicians, intensivists, and infectious diseases/antimicrobial stewardship pharmacists. The working group regularly reviewed literature to select important patient characteristics, diagnostics, and outcomes for inclusion. The data collection tool consisted of spreadsheets developed to collect data from the electronic medical record and track the clinical course after treatments. RESULTS: Data collection focused on demographics and exposure epidemiology, prior medical history and medications, signs and symptoms, diagnostic test results, interventions, clinical outcomes, and complications. During the pilot validation phase, there was <10% missing data for most domains and components. Team members noted improved efficiency and decision making by using the tool during interdisciplinary rounds. CONCLUSIONS: We present the development of a COVID-19 data collection tool and propose its use to effectively assemble harmonized data of hospitalized individuals with COVID-19. This tool can be used by clinicians, researchers, and quality improvement healthcare teams. It has the potential to facilitate interdisciplinary rounds, provide comparisons across different hospitalized populations, and adapt to emerging challenges posed by the pandemic.

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