Probiotics influencing response of antibodies over time in seniors after COVID-19 vaccine (PIRATES-COV): a randomised controlled trial protocol

Introduction
The elderly are particularly vulnerable to morbidity and mortality from COVID-19, the disease caused by the SARS-CoV-2. Approximately 20% of the elderly showed no antibodies 3–5 months post-second dose of the COVID-19 vaccine. As probiotics have been shown to increase influenza-specific antibody levels post-influenza vaccination, we aim to reduce the percentage of participants without antibodies against the SARS-CoV-2 spike protein receptor-binding domain (anti-S1-RBD) at 6 months post-vaccination.

Methods and analysis
Our study design is a double-blind randomised controlled trial, using intention-to-treat analysis. Eligible participants are a purposive sample of 688 adults aged 65–89 years, in Quebec, Canada, not diagnosed with COVID-19 in the 3 months prior to recruitment and who wish to receive a government-recommended mRNA booster (Pfizer-BioNTech, Moderna) vaccine. The intervention consists of one capsule/day of a probiotic dietary supplement of Lacticaseibacillus rhamnosus and Lacticaseibacillus casei 6×109 CFU/capsule or a placebo, for 15 days pre-booster and post-booster vaccine. All participants provide dried blood spot samples at three timepoints (inclusion, 3 and 6 months post-vaccination) and a stool sample for microbiome analysis. A subgroup of 100 participants living near Sherbrooke, Quebec, is expected to volunteer for two onsite blood-test visits (at inclusion and 6 months post-vaccination). The primary outcome is the percentage of participants without anti-S1-RBD antibodies at 6 months post-vaccination. Secondary outcomes include longitudinal analysis of anti-S1-RBD and anti-N antibodies at three timepoints. In the subgroup, serum levels of neutralising antibodies will be determined at inclusion and 6 months post-vaccination. Probiotic and vaccine side effects are monitored. At the end of the study, we expect to identify the adjuvant effect of probiotic on vaccine-induced immune response.

Ethics and dissemination
The study was approved by Research Ethics Board of the Centre Intégré Universitaire de Santé et des Services Sociaux de l’Estrie- Centre Hospitalier Universitaire de Sherbrooke (CIUSSS de l’Estrie-CHUS) and the CHU de Québec-Université Laval # MP-31-2022-4598 as well as Health Canada. All participants will provide informed consent. Results will be disseminated to the scientific community and to all networks related in this research.

Trial registration number
NCT05195151.

Leggi
Marzo 2025

COVER-ME: developing and evaluating community-based interventions to promote vaccine uptake for COVID-19 and influenza in East London minority ethnicity (ME) and underserved individuals – protocol for a pilot randomised controlled trial

Introduction
Under-vaccination among underserved groups remains low due to existing disparities. This is particularly the case with postpandemic COVID-19 vaccinations and other vaccine-preventable diseases, including measles, mumps, rubella or influenza. Therefore, we aim to (1) determine the feasibility and practicality of implementing a patient engagement tool (PET) and gain vital insights to plan a subsequent definitive randomised controlled trial (RCT) to evaluate the effectiveness of this tool for increasing uptake of COVID-19 and influenza vaccinations and (2) define the appropriate level of support needed for healthcare providers at site-level to ensure successful implementation of the PET and to identify supporting activities needed to implement interventions for COVID-19 and influenza vaccinations.

Methods and analysis
This is a randomised controlled feasibility study evaluating a co-designed PET, involving randomisation at individual and cluster levels. For individual randomisation, patients will be individually randomised 1:1 to receive the intervention (PET) or routine care; whereas for cluster randomisation, six GP (General Practitioner) practices will be randomised 1:1 and divided into two tranches at two separate time points. Both groups will receive training and software activation. Data will be analysed using statistical software R (V.4.0 or greater) or STATA (V.17 or greater). Baseline characteristics will be summarised and presented in groups based on an intention-to-treat basis with categorical data, including demographics, socioeconomic variables, comorbidities and vaccination status.

Ethics and dissemination
Ethical approval was granted by the Westminster Ethics Committee (ref: 316860). Our dissemination strategy targets three audiences: (1) policy makers, public and health service managers, and clinicians responsible for delivering vaccines and infection prevention services; (2) patients and public from underserved population groups and (3) academics.

Trial registration number
ClinicalTrials.gov (NCT05866237).

Leggi
Marzo 2025

COVID-19 information sources, knowledge, attitude and control practices among community members during the pandemic in Ebonyi state, Nigeria: an analytical cross-sectional study

Objectives
After taking a heavy toll on the world population, the COVID-19 pandemic is now an endemic disease of global public health significance that requires long-term application of control measures, which will likely be influenced by people’s sources of information, knowledge and attitude about COVID-19 and their previous use of control measures. This study aimed to further the understanding of COVID-19 information sources, knowledge, attitude and control practices and their predictors among community members in Ebonyi state, Nigeria during the COVID-19 pandemic.

Design
Analytical cross-sectional survey.

Setting and participants
We conducted a survey among all consenting/assenting community members aged 15 years and above in 28 randomly selected geographical clusters between 12 March and 9 May 2022. Data were collected through a structured, interviewer-administered questionnaire using KoBoCollect installed in Android devices.

Analysis
Descriptive and inferential statistical analyses were done, including multivariate generalised estimating equations.

Results
10 825 participants were surveyed. The radio was the most common individual source of information about COVID-19 (used by 71.9% of the participants), and also the main and most trusted source of information for majority of the participants (46.1% and 44.7%, respectively). This was followed by family members/relatives/friends (61.8%) as the next most common source of information about COVID-19. Next to radio, family members/relatives/friends (13.2%) were the second main source of information, followed by health workers (13.0%). Meanwhile, health workers (15.2%) were the second most trusted source of COVID-19 information, next to radio. Traditional media was the main and also the most trusted source of information (55.6% and 54.3%, respectively), followed by interpersonal sources (36.9% and 39.7%, respectively) and internet/social media/text messages (7.5% and 6.0%, respectively). 10.1%, 51.4% and 23.7% of the participants had good knowledge, good attitude and good control practice, respectively. The strongest and most important predictor of the main and most trusted sources of information was gender. Other predictors included marital status, educational level, age and occupation. Good attitude, being married and educational level were strong predictors of good control practices.

Conclusion
The evidence from this study should be used to guide subsequent policy actions on COVID-19 or other similar health emergencies in order to enhance effective emergency health information dissemination and optimal use of control measures by community members in Ebonyi state, Nigeria and in other similar settings.

Leggi
Marzo 2025

Effect of COVID-19 with or without acute kidney injury on inpatient mortality in England: a national observational study using administrative data

Objectives
To evaluate hospital outcomes and their predictors during the pandemic for patients with and without COVID-19, stratified by the presence of acute kidney injury (AKI).

Design
Retrospective observation study using the Hospital Episodes Statistics database for England.

Participants
2 385 337 unique hospital admissions of adult patients from March 2020 to March 2021 in England.

Main outcome measures
COVID-19 cases were identified by the International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) code of U07.1. Patients with suspected COVID-19 (U07.2 code) and patients with end-stage kidney disease on chronic dialysis (N18.6 and Z99.2) were excluded. AKI cases were identified by the ICD10 code. Patients were categorised into four groups based on COVID-19 and AKI diagnoses: Group 1—neither; Group 2—COVID-19 only; Group 3—AKI only; Group 4—both. A multivariable logistic regression model was created with in-hospital mortality as the outcome, including diagnostic groups, demographics, admission methods, comorbidity severity, deprivation index and intensive therapy unit (ITU) admission.

Results
Among 2 385 337 admissions involving 663 628 patients, 856 544 had AKI (N17 codes) and 1 528 793 did not. Among patients without AKI, there were 1,008,774 admissions among 133,988 individuals without COVID-19 (Group 1) and 520,019 admissions among 256,037 individuals with COVID-19 (Group 2). Among patients with AKI, there were 630,342 admissions among 218,270 individuals without COVID-19 (Group 3) and 226,202 admissions among 55,333 individuals with COVID-19 (Group 4). Patients in group 4 were older (75.4 ± 13.8 years) and had greater length of stay (17.1 ± 17 days) than all other groups. They also had and had a greater proportion of males, ethnic minorities and comorbidities than other groups. Mortality was highest in Group 4 (28.7%) and lowest in Group 1 (1.1%). The increased risk of death persisted after controlling for multiple baseline factors (OR for death vs Group 1: Group 4—22.28, Group 2—9.67, Group 3—6.44). ITU admission was least required in Group 1 (1.2%) and most in Group 4 (10.9%), with mortality at 4.8% versus 47.8%, respectively.

Conclusions
Patients with COVID-19 and AKI have a high risk of mortality and should be recognised early and provided with optimal support. Planning for future pandemics should ensure adequate critical care and acute dialysis capacity.

Trial registration number
NCT04579562.

Leggi
Marzo 2025

Prioritising community-defined interventions to address the health and well-being impact of the COVID-19 pandemic on racially minoritised communities in East London: results from an adapted James Lind Alliance priority setting partnership

Objectives
Racially minoritised communities (RMCs) were disproportionately affected by COVID-19, experiencing among the highest mortality rates of the UK’s pandemic. We sought to understand the priorities for action to address the impact of the COVID-19 pandemic on the health and well-being of RMCs in the ethnically diverse and socioeconomically unequal area of East London, located in the northeastern part of London, England.

Design
Prospective surveys and a consensus meeting following the established James Lind Alliance priority setting partnership (PSP) methodology, adapted for a specific geographic location and ethnic groups.

Setting
Conducted in East London between 2021 and 2023.

Participants
Participants were individuals aged ≥18 years living and/or working in East London. Communities represented included Black African, Black Caribbean, Somali, South Asian and Bangladeshi.

Outcome measure
People were asked to submit suggestions for the priorities for action to address the impact of the COVID-19 pandemic. Return responses were reviewed and prioritised in a final workshop.

Results
816 suggestions were gathered from 187 responses to the initial survey. These were summarised into a longlist of 40 for the second survey, from which 243 respondents identified a shortlist of 26 priorities for discussion in a consensus meeting. The final top 10 priorities cover community-based support and spaces spanning education, social support, mental health and housing.

Conclusion
A systematic methodology was used to identify the priorities of RMCs in East London in the context of recovery from the COVID-19 pandemic. The breadth of the top 10 reflects how profound the effects of the pandemic have been among these communities. It also demonstrates the capacity of a PSP to articulate diverse community-driven priorities for a topic that was wider than healthcare. The findings could have applications in other disease areas that disproportionately affect RMCs.

Leggi
Marzo 2025

Access and use of general and mental health services before and during the COVID-19 pandemic: a systematic review and meta-analysis

Objectives
To quantify access to health services during the COVID-19 pandemic and measure the change in use between the prepandemic and the pandemic periods in a population with assessment of psychological distress or diagnosis of mental disorders.

Data sources
We developed and piloted a search syntax and adapted it to enter the following databases from 1 January 2020 to 31 March 2023: PubMed/MEDLINE, PsycINFO, Web of Science, Epistemonikos and the WHO International Clinical Trials Registry Platform. We reran the searches from the end of the original search to 3 December 2024.

Design
We systematically screened titles, abstracts and full texts of retrieved records.

Eligibility criteria
We included observational studies on any populations and regions, covering health services such as doctor visits, hospital admissions, diagnostic examinations, pharmaceutical therapies and mental health (MH) services. Only studies using validated scales to assess psychological distress or mental disorders as defined in the Diagnostic and Statistical Manual of Mental Disorders were included.

Data extraction and synthesis
We extracted data using a purposefully designed form and evaluated the studies’ quality with the Newcastle-Ottawa Scale. We measured the incidence rate (IR) of access to health services and the IR ratio (IRR) between the prepandemic and the pandemic periods. We calculated contacts days and catchment areas in the different periods. We used the random effects DerSimonian-Laird inverse-variance model and calculated heterogeneity with statistics I² and ². We computed pooled IR and pooled IRR and tested the hypothesis of no variation (IRR=1).

Results
We retrieved 10 014 records and examined the full text of 580 articles. We included 136 primary studies of which 44 were meta-analysed. The IR of access to services during the pandemic was 2.59 contact months per 10 000 inhabitants (IR=2.592; 95% CI: 1.301 to 5.164). We observed a reduction of 28.5% in the use of services with negligible differences by age group and type of services (IRR=0.715; 95% CI: 0.651 to 0.785). We observed significant differences in effect sizes across studies (2=5.44; p

Leggi
Marzo 2025

Lesson learnt from the COVID-19 pandemic: a qualitative inquiry into patient and family experiences in Pakistan

Objectives
This study aims to explore the perceptions of patients affected by COVID-19 and their families regarding the challenges faced, coping strategies used and lessons learnt in Pakistan.

Design
A qualitative exploratory descriptive approach was used to explore the real-time experiences of the participants.

Setting
The study was carried out in a tertiary care hospital in Karachi, Pakistan.

Participants
Purposive and snowball sampling methods were used to enrol 22 dyads of adult patients diagnosed with COVID-19 and their respective family members (FMs) (spouse, children, siblings or any other FM sharing a residence in Karachi, Pakistan, with the patient before quarantine). The 44 participants, with 23 females and 21 males, had an average age of 43.2 years.

Results
We identified five key themes: practising a healthy diet and physical activity to boost immunity; developing workplace policies for job security, safety and mental well-being; encouraging digitalisation of health through teleconsultation and virtual learning; using technology and artificial intelligence to transform healthcare delivery systems; and empowering resilience and community unity to promote mental well-being.

Conclusion
The study summarises the opinions of people directly affected by COVID-19 and the stakeholders of systemic challenges. The findings of the study can guide further strengthening of the healthcare system and improvements of organisational policies to facilitate better preparation of marginalised communities for future pandemics.

Leggi
Marzo 2025

Representative national survey on drug use during the COVID-19 stay-at-home order in the USA

Objectives
This study explores the drug use behaviour in the US general population in the early days of the COVID-19 pandemic with a focus on the relationship between sociopsychological factors, mobility restrictions from March to June 2020 and mental health conditions.

Design
A retrospective anonymous online survey representing a cross-section of the US population in 2020.

Setting
A qualified panel of 500 000 Qualtrics participants stratified by gender, race, age and geographical region to represent the US population.

Participants
3340 participants voluntarily consented to respond.

Measures
Outcome measure for illicit and non-medical use of prescription drugs based on the National Institute on Drug Abuse-Modified Alcohol, Smoking and Substance Involvement Screening Test Level-2 Substance Use for Adult Questionnaire and predictor measures include self-reports of mobility behaviours, demographics and mental states using psychometrically validated scales.

Results
2 tests showed that those who stayed home reported higher odds (p

Leggi
Marzo 2025

Assessing the impact of COmorbidities and Sociodemographic factors on Multiorgan Injury following COVID-19: rationale and protocol design of COSMIC, a UK multicentre observational study of COVID-negative controls

Introduction
SARS-CoV-2 disease (COVID-19) has had an enormous health and economic impact globally. Although primarily a respiratory illness, multi-organ involvement is common in COVID-19, with evidence of vascular-mediated damage in the heart, liver, kidneys and brain in a substantial proportion of patients following moderate-to-severe infection. The pathophysiology and long-term clinical implications of multi-organ injury remain to be fully elucidated. Age, gender, ethnicity, frailty and deprivation are key determinants of infection severity, and both morbidity and mortality appear higher in patients with underlying comorbidities such as ischaemic heart disease, hypertension and diabetes. Our aim is to gain mechanistic insights into the pathophysiology of multiorgan dysfunction in people with COVID-19 and maximise the impact of national COVID-19 studies with a comparison group of COVID-negative controls.

Methods and analysis
COmorbidities and Sociodemographic factors on Multiorgan Injury following COVID-19 (COSMIC) is a prospective, multicentre UK study which will recruit 200 subjects without clinical evidence of prior COVID-19 and perform extensive phenotyping with multiorgan imaging, biobank serum storage, functional assessment and patient reported outcome measures, providing a robust control population to facilitate current work and serve as an invaluable bioresource for future observational studies.

Ethics and dissemination
Approved by the National Research Ethics Service Committee East Midlands (REC reference 19/EM/0295). Results will be disseminated via peer-reviewed journals and scientific meetings.

Trial registration number
COSMIC is registered as an extension of C-MORE (Capturing Multi-ORgan Effects of COVID-19) on ClinicalTrials.gov (NCT04510025).

Leggi
Marzo 2025