ABSTRACT
Background: Vitamin D can stall hyper-inflammatory responses, and there are mechanistic reasons for the positive effects of vitamin D in COVID-19 patients. Objectives: Therefore, this study aimed to evaluate the effect of a single high dose of vitamin D on inflammatory markers in critical patients with COVID-19. Design and patients: A single center, double-blind, randomized clinical trial was conducted on 61 patients with COVID-19 admitted to the intensive care units. The intervention and placebo groups received a dose of 300,000 IU vitamin D intramuscularly and identical placebo respectively. Patients were followed up for one week. Lactate Dehydrogenase (LDH) (IU/ml), C-reactive protein (CRP) (mg/L), interleukin-6 (IL-6) (Pg/L), lymphocyte, neutrophil, and neutrophil/lymphocyte (N/L) ratios were checked at the beginning and 7 th day of the study. Key results: A total of 44 patients with COVID-19 have completed this trial with vitamin D insufficiency in the baseline. The lymphocyte level increased while LDH (IU/ml), neutrophil level, and N/L ratio decreased after intervention with a high vitamin D dose, which was insignificant. The CRP (mg/L) and IL-6 (Pg/L) were significantly reduced after high-dose vitamin D intervention. Conclusions: Based on the results, the effect of high doses of vitamin D on inflammatory indices was significant in patients with COVID-19 hospitalized in the ICU.
Subject(s)
COVID-19 , Addison DiseaseABSTRACT
Importance: Little is known about COVID vaccine breakthrough infections and their risk factors. Objective: To identify risk factors associated with COVID19 breakthrough infections among vaccinated individuals and to reassess the effectiveness of COVID19 vaccination against severe outcomes using realworld data. Design, Setting, and Participants: We conducted a series of observational retrospective analyses using the electronic health records (EHRs) of Columbia University Irving Medical Center/New York Presbyterian (CUIMC/NYP) up to September 21, 2021. New York adult residence with PCR test records were included in this analysis. Main Outcomes and Measures: Poisson regression was used to assess the association between breakthrough infection rate in vaccinated individuals and multiple risk factors, including vaccine brand, demographics, and underlying conditions while adjusting for calendar month, prior number of visits and observational days. Logistic regression was used to assess the association between vaccine administration and infection rate by comparing a vaccinated cohort to a historically matched cohort in the pre-vaccinated period. Infection incident rate was also compared between vaccinated individuals and longitudinally matched unvaccinated individuals. Cox regression was used to estimate the association of the vaccine and COVID19 associated severe outcomes by comparing breakthrough cohort and two matched unvaccinated infection cohorts. Results: Individuals vaccinated with Pfizer/BNT162b2 (IRR against Moderna/mRNA1273 [95% CI]: 1.66 [1.17 - 2.35]); were male (1.47 [1.11 - 1.94%]); and had compromised immune systems (1.48 [1.09 - 2.00]) were at the highest risk for breakthrough infections. Vaccinated individuals had a significant lower infection rate among all subgroups. An increased incidence rate was found in both vaccines over the time. Among individuals infected with COVID19, vaccination significantly reduced the risk of death (adj. HR: 0.20 [0.08 - 0.49]). Conclusion and Relevance: While we found both mRNA vaccines were effective, Moderna/mRNA1273 had a lower incidence rate of breakthrough infections. Both vaccines had increased incidence rates over the time. Immunocompromised individuals were among the highest risk groups experiencing breakthrough infections. Given the rapidly changing nature of the SARSCoV2, continued monitoring and a generalizable analysis pipeline are warranted to inform quick updates on vaccine effectiveness in real time.