Exploring the impact of gut microbial metabolites on inactivated SARS-CoV-2 vaccine efficacy during pregnancy and mother-to-infant antibody transfer

The recent publication by Ng et al titled ‘Gut microbiota composition is associated with SARS-CoV-2 vaccine immunogenicity and adverse events’ provides valuable insights on gut microbiota in modulating immune responses to both inactivated (CoronaVac) and mRNA (BNT162b2) SARS-CoV-2 vaccines. The authors identified specific gut microbiota markers influenced immunity and vaccine efficacy, suggesting that microbiota-targeted interventions could potentially enhance vaccine effectiveness in adults.1 Expanding on Ng et al’s research, our study further investigates the associations between gut microbial taxa, metabolites and immune response to inactivated vaccines. Our findings establish a connection between maternal gut microbiota/metabolites and the efficacy of mother-to-infant antibody transfer, providing a potential protective strategy for infants against COVID-19 symptoms. We conducted a prospective, observational investigation involving 97 vaccinated pregnant women in Guangdong, China, and profiled gut microbiota and metabolome using shotgun metagenomics and non-targeted metabolomics. All participants received two doses of inactivated SARS-CoV-2 vaccine, including…

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Luglio 2024

Evolution of serious and life-threatening COVID-19 pneumonia as the SARS-CoV-2 pandemic progressed: an observational study of mortality to 60 days after admission to a 15-hospital US health system

Objective
In order to predict at hospital admission the prognosis of patients with serious and life-threatening COVID-19 pneumonia, we sought to understand the clinical characteristics of hospitalised patients at admission as the SARS-CoV-2 pandemic progressed, document their changing response to the virus and its variants over time, and identify factors most importantly associated with mortality after hospital admission.

Design
Observational study using a prospective hospital systemwide COVID-19 database.

Setting
15-hospital US health system.

Participants
26 872 patients admitted with COVID-19 to our Northeast Ohio and Florida hospitals from 1 March 2020 to 1 June 2022.

Main outcome measures
60-day mortality (highest risk period) after hospital admission analysed by random survival forests machine learning using demographics, medical history, and COVID-19 vaccination status, and viral variant, symptoms, and routine laboratory test results obtained at hospital admission.

Results
Hospital mortality fell from 11% in March 2020 to 3.7% in March 2022, a 66% decrease (p

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Luglio 2024

Assessing healthcare workers confidence level in diagnosing and managing emerging infectious virus of human mpox in hospitals in Amhara Region, Northwest Ethiopia: multicentre institution-based cross-sectional study

Objective
To assess healthcare workers’ (HCWs) confidence level in diagnosing and managing mpox disease and its associated factors in hospitals in the Amhara Region.

Design
Institution-based cross-sectional study.

Setting
Hospitals in the Amhara Region, Northwest Ethiopia.

Participants
A total of 640 HCWs, with a response rate of 96.9%, participated from 1 October to 30 December 2022. A multistage stratified random sampling technique with proportional allocation was used to recruit study participants. Data were collected using the KoboCollect toolbox and exported to STATA V.17 for analysis. Descriptive statistics were used to describe data. Ordinal logistic regression analysis was used to identify predictors of confidence level to diagnose and manage mpox at p

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Luglio 2024

Evaluation of a novel university-based testing platform to increase access to SARS-CoV-2 testing during the COVID-19 pandemic in a cohort study

Objective
We aimed to evaluate the feasibility and utility of an unsupervised testing mechanism, in which participants pick up a swab kit, self-test (unsupervised) and return the kit to an on-campus drop box, as compared with supervised self-testing at staffed locations.

Design
University SARS-CoV-2 testing cohort.

Setting
Husky Coronavirus Testing provided voluntary SARS-CoV-2 testing at a university in Seattle, USA.

Outcome measures
We computed descriptive statistics to describe the characteristics of the study sample. Adjusted logistic regression implemented via generalised estimating equations was used to estimate the odds of a self-swab being conducted through unsupervised versus supervised testing mechanisms by participant characteristics, including year of study enrolment, pre-Omicron versus post-Omicron time period, age, sex, race, ethnicity, affiliation and symptom status.

Results
From September 2021 to July 2022, we received 92 499 supervised and 26 800 unsupervised self-swabs. Among swabs received by the laboratory, the overall error rate for supervised versus unsupervised swabs was 0.3% vs 4%, although this declined to 2% for unsupervised swabs by the spring of the academic year. Results were returned for 92 407 supervised (5% positive) and 25 836 unsupervised (4%) swabs from 26 359 participants. The majority were students (79%), 61% were female and most identified as white (49%) or Asian (34%). The use of unsupervised testing increased during the Omicron wave when testing demand was high and stayed constant in spring 2022 even when testing demand fell. We estimated the odds of using unsupervised versus supervised testing to be significantly greater among those

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Giugno 2024

Study protocol for assessment of the efficacy of calcium dobesilate versus placebo on SARS-CoV-2 viral load in outpatients with COVID-19 (CADOVID study): a randomised, placebo-controlled, double-blind, monocentric phase II trial

Introduction
SARS-CoV-2 mainly infects respiratory endothelial cells, which is facilitated through its spike protein binding to heparan sulphate. Calcium dobesilate (CaD) is a well-established, widely available vasoactive and angioprotective drug interacting with heparan sulphate, with the potential to interfere with the uptake of SARS-CoV-2 by epithelial cells. The CADOVID trial aims to evaluate the efficacy and safety of CaD in reducing the SARS-CoV-2 viral load in non-hospitalised adult patients diagnosed with COVID-19, confirmed by a positive SARS-CoV-2 PCR, including its efficacy to reduce the impact of persistent COVID-19 symptoms.

Methods and analysis
This is a randomised, placebo-controlled, double-blind, monocentric phase II trial. Enrolment began in July 2022. A total of 74 adult patients will be randomly allocated to the CaD arm or the placebo group with a 1:1 ratio, respectively. Participants in the intervention arm will receive two capsules of CaD 500 mg two times per day and the placebo arm will receive two matching capsules of mannitol 312.5 mg two times per day, with a treatment period of 7 days for both arms, followed by a 77-day observational period without treatment administration. Participants will be asked to complete secured online questionnaires using their personal smartphone or other electronic device. These include a COVID-19 questionnaire (assessing symptoms, temperature measurement, reporting of concomitant medication and adverse events), a COVID-19 persistent symptoms’ questionnaire and the Short Form 12-Item (SF-12) survey. SARS-CoV-2 PCR testing will be performed on nasopharyngeal swabs collected on days 1, 4, 8 and 21. The primary endpoint is the reduction from baseline of SARS-CoV-2 viral load determined by RT-PCR at day 4.

Ethics and dissemination
This trial has received approval by the Geneva Regional Research Ethics Committee (2022-00613) and Swissmedic (701339). Dissemination of results will be through presentations at scientific conferences and publication in scientific journals.

Trial registration number
NCT05305508; Clinicaltrials.gov; Swiss National Clinical Portal Registry (SNCTP 000004938).

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Maggio 2024