Risultati per: Identificate le origini evolutive di SARS-CoV-2

Introduction
People who are immunocompromised have a poor biological response to vaccinations. This study aims to determine in patients with chronic lymphocytic leukaemia (CLL) if a 3-week pause in Bruton tyrosine kinase inhibitor therapy (BTKi) starting 1 week before delivery of SARS-CoV-2 vaccine booster, improves vaccine immune response when compared with continuation of BTKi.

Methods and analysis
An open-label, randomised controlled superiority trial will be conducted in haematology clinics in approximately 10 UK National Health Service (NHS) hospitals. The sample size is 120, randomised 1:1 to intervention and usual care arms. The primary outcome is anti-spike-receptor binding domain (RBD) antibody level at 3 weeks post-SARS-CoV-2 booster vaccination. Secondary outcomes are RBD antibody levels at 12 weeks postbooster vaccination, participant global assessments of disease activity, blood films, full blood count and lactate dehydrogenase levels, impact on quality of life, self-reported adherence with request to temporarily pause or continue BTKi, T cell response against spike protein and relative neutralising antibody titre against SARS-CoV-2 viral variants. Additionally, there will be an investigation of any effects in those given influenza vaccination contemporaneously versus COVID-19 alone.
The primary analysis will be performed on the as randomised groups (‘intention to treat’). The difference between the study arms in anti-spike-RBD antibody level will be estimated using a mixed effects regression model, allowing for repeated measures clustered within participants. The model will be adjusted for randomisation factor (first line or subsequent line of therapy), and prior infection status obtained from prerandomisation antinucleocapsid antibodies as fixed effects.

Ethics and dissemination
This study has been approved by Leeds East Research Ethics Committee and Health Research Authority (REC Reference:22/YH/0226, IRAS ID: 319057). Dissemination will be via peer-review publications, newsletters and conferences. Results will be communicated to participants, the CLL patient and clinical communities and health policy-makers.

Trial registration number
ISRCTN14197181.

This longitudinal study of young children in 5 European countries investigates whether there is a temporal association between SARS-CoV-2 infection and islet autoimmunity when children are most susceptible.

Objective
COVID-19 would kill fewer people if health programmes can predict who is at higher risk of mortality because resources can be targeted to protect those people from infection. We predict mortality in a very large population in Mexico with machine learning using demographic variables and pre-existing conditions.

Design
Cohort study.

Setting
March 2020 to November 2021 in Mexico, nationally represented.

Participants
1.4 million laboratory-confirmed patients with COVID-19 in Mexico at or over 20 years of age.

Primary and secondary outcome measures
Analysis is performed on data from March 2020 to November 2021 and over three phases: (1) from March to October in 2020, (2) from November 2020 to March 2021 and (3) from April to November 2021. We predict mortality using an ensemble machine learning method, super learner, and independently estimate the adjusted mortality relative risk of each pre-existing condition using targeted maximum likelihood estimation.

Results
Super learner fit has a high predictive performance (C-statistic: 0.907), where age is the most predictive factor for mortality. After adjusting for demographic factors, renal disease, hypertension, diabetes and obesity are the most impactful pre-existing conditions. Phase analysis shows that the adjusted mortality risk decreased over time while relative risk increased for each pre-existing condition.

Conclusions
While age is the most important predictor of mortality, younger individuals with hypertension, diabetes and obesity are at comparable mortality risk as individuals who are 20 years older without any of the three conditions. Our model can be continuously updated to identify individuals who should most be protected against infection as the pandemic evolves.

Background
COVID-19 has caused morbidity, hospitalisation and mortality worldwide. Despite effective vaccines, there is still a need for effective treatments, especially for people in the community. Dietary supplements have long been used to treat respiratory infections, and preliminary evidence indicates some may be effective in people with COVID-19. We sought to evaluate whether a combination of vitamin C, vitamin D3, vitamin K2 and zinc could improve overall health and decrease symptom burden in outpatients diagnosed with COVID-19.

Methods
Participants were randomised to receive either vitamin C (6 g), vitamin D3 (1000 units), vitamin K2 (240 μg) and zinc acetate (75 mg) or placebo daily for 21 days and were followed for 12 weeks. An additional loading dose of 50 000 units vitamin D3 (or placebo) was given on day one. The primary outcome was participant-reported overall health using the EuroQol Visual Assessment Scale summed over 21 days. Secondary outcomes included health status, symptom severity, symptom duration, delayed return to usual health, frequency of hospitalisation and mortality.

Results
90 patients (46 control, 44 treatment) were randomised. The study was stopped prematurely due to insufficient capacity for recruitment. The mean difference (control–treatment) in cumulative overall health was –37.4 (95% CI –157.2 to 82.3), p=0.53 on a scale of 0–2100. No clinically or statistically significant differences were seen in any secondary outcomes.

Interpretation
In this double-blind, placebo-controlled, randomised trial of outpatients diagnosed with COVID-19, the dietary supplements vitamin C, vitamin D3, vitamin K2 and zinc acetate showed no clinically or statistically significant effects on the documented measures of health compared with a placebo when given for 21 days. Termination due to feasibility limited our ability to demonstrate the efficacy of these supplements for COVID-19. Further research is needed to determine clinical utility.

Trial registration number
NCT04780061.

Dufour et al highlighted that the effect of COVID-19 in patients with cirrhosis is derived from the prevaccination era and suggested that the impact of Omicron infection in patients with cirrhosis needs to be elucidated.1 We agree with the author that previous studies have reported significant morbidity and mortality in patients with cirrhosis infected with SARS CoV-2 in the prevaccination era.2–7 To our knowledge, no studies have assessed the impact of Omicron infection in patients with cirrhosis. Therefore, we aimed to compare the outcomes of Omicron infection among patients with cirrhosis and without cirrhosis. We retrospectively included non-cirrhotic (NC) patients and patients with cirrhosis from 1 January 2022 to 1 March 2022 diagnosed with Omicron infection. Omicron BA.1 variant was identified based on the S-gene dropout on the reverse transcriptase PCR test. In the absence…

Recently, we read the article by Ng et al with great interest,1 which identified several gut microbiota harbour the potential to improve immune response and reduce adverse events following COVID-19 vaccines, and demonstrated that gut microbiota has the potential to complement the effectiveness of vaccines. Together with several recent studies, gut microbiota plays a key role in modulating immune responses of vaccination2–4 and is related to the severity of COVID-19 patients,5 6 however, the comprehensive assessment of host’s response, particularly the role of gut microbiota in antibodies production is limited and should be seriously considered because the vaccination of SARS-CoV-2 is the most promising approach for curbing the COVID-19 pandemic.4 7 Therefore, we recruited 30 young volunteers (20–23 years old), including 15 male and 15 female volunteers, and collected 143 faecal and 120…

In Reply We thank Dr Yang and colleagues for their interest in our study and for highlighting that post−COVID-19 condition (PCC) is of important public health interest. They mention specific studies and rightly ask why these were not included in our meta-analysis. For the purposes of transparency, our inclusion and exclusion criteria were clearly listed in the Methods section of the article. Reviewing the suggested studies against our criteria easily demonstrates that none met the inclusion criteria we outlined. Those studies either did not clearly report the duration of symptoms since the acute COVID-19 infection—whereas we followed the World Health Organization definition, which requires a symptom duration of greater than 3 months; or they investigated the effect of vaccination on the resolution of PCC symptoms (vs identifying the association of risk of developing PCC and vaccination which was our study aim); or they discussed how vaccination affected the various PCC symptoms. Hence, we confirm that none of the proposed studies fulfilled the inclusion criteria for the specific purpose of our systematic review and meta-analysis.

To the Editor In their recent systematic review and meta-analysis, Dr Tsampasian and colleagues reported risk factors associated with post−COVID-19 condition (PCC). According to the study analysis, female sex, older age, higher body mass index, smoking, preexisting comorbidities, and previous hospitalization or intensive care admission were significantly associated with developing PCC, and SARS-CoV-2 vaccination with 2 doses was associated with a lower risk of PCC. Although this article presents a topical research subject with a strong potential effect, 2 key issues need to be clarified before more robust conclusions can be made.

Introduction
There is currently limited evidence addressing perioperative prognosis of surgical patients during COVID-19 pandemic; especially targeting on the Chinese population since the wave in 2022. Considering a distinct feature from the rest of the world demonstrated and the fast mutation and spread of the virus, evidence most relevant to China is urgently in need. The objective of this study is to seek for supporting evidence via evidence-based risk evaluations for postoperative complications to accumulate experience for coming infection waves.

Methods and analysis
This protocol proposes a multicentral, prospective, observational cohort study aiming to explore the link between SARS-CoV-2 infection and postoperative complications among surgical patients under general or regional anaesthesia between 16 January 2023 and 31 December 2023. A retrospective cohort covering the same period in 2019 is extracted for historic reference. Data are extracted from the health information system and anaesthesia information management system. The COVID-19 information is collected via an online survey. Missing values in weight or height will be imputed by each other with age and gender via multiple imputation. Other missing values will not be handled specially. Standard descriptive statistics will be reported followed by statistical modelling. Binomial regression with logit link is used for binary outcome. The time-to-event outcome is analysed using Cox regression with discharge from hospital further treated as a competing state. Hierarchical models will be assessed to account for temporal or central random effects. Temporal trends will be displayed with future expectations.

Ethics and dissemination
Ethical approval is obtained from the ethical committee in Xijing Hospital (No. KY20232002-C-1); approvals are expected for each participating institute. Verbal consent will be informed and obtained prior to online survey collection. Personal information remains confidential, and publications will be deidentified.

Trial registration number
NCT05677815.

This study examines the use of COVID-19 antiviral treatments in US nursing homes and the facility characteristics associated with use of oral antivirals and monoclonal antibodies.

SARS-CoV-2 infection may affect the liver in healthy individuals but also influences the course of COVID-19 in patients with chronic liver disease (CLD). As described in healthy individuals, a strong SARS-CoV-2-specific adaptive immune response is important for the outcome of COVID-19, however, knowledge on the adaptive immune response in CLD is limited.
Here, we review the clinical and immunological features of SARS-CoV-2 infection in individuals with CLD. Acute liver injury occurs in many cases of SARS-CoV-2 infection and may be induced by multiple factors, such as cytokines, direct viral infection or toxic effects of COVID-19 drugs. In individuals with CLD, SARS-CoV-2 infection may have a more severe course and promote decompensation and particularly in patients with cirrhosis. Compared with healthy individuals, the SARS-CoV-2-specific adaptive immune responses is impaired in patients with CLD after both, natural infection and vaccination but improves at least partially after booster vaccination.
Following SARS-CoV-2 vaccination, rare cases of acute vaccine-induced liver injury and the development of autoimmune-like hepatitis have been reported. However, the concomitant elevation of liver enzymes is reversible under steroid treatment.

Objective
This study investigated the seroprevalence of SARS-CoV-2 antibodies among adults over 18 years.

Design
Prospective cohort study.

Settings
A large public university.

Participants
This study took volunteers over 5 days and recruited 1064 adult participants.

Primary outcome measures
Seroprevalence of SARS-CoV-2-specific antibodies due to previous exposure to SARS-CoV-2 and/or vaccination.

Results
The seroprevalence of the antireceptor binding domain (RBD) antibody was 90% by a lateral flow assay and 88% by a semiquantitative chemiluminescent immunoassay. The seroprevalence for antinucleocapsid was 20%. In addition, individuals with previous natural COVID-19 infection plus vaccination had higher anti-RBD antibody levels compared with those who had vaccination only or infection only. Individuals who had a breakthrough infection had the highest anti-RBD antibody levels.

Conclusion
Accurate estimates of the cumulative incidence of SARS-CoV-2 infection can inform the development of university risk mitigation protocols such as encouraging booster shots, extending mask mandates or reverting to online classes. It could help us to have clear guidance to act at the first sign of the next surge as well, especially since there is a surge of COVID-19 subvariant infections.

New England Journal of Medicine, Volume 389, Issue 5, Page 474-475, August 2023.

This nationwide cohort study assesses the association of SARS-CoV-2 infection and subsequent risk of mental disorders and use of psychotropic medication among the adult population of Denmark.

This quality improvement study examines the association between the discontinuation of universal admission testing for SARS-CoV-2 infections and hospital-onset SARS-CoV-2 infections in England and Scotland.

New England Journal of Medicine, Ahead of Print.