Ten sessions of hyperbaric oxygen versus sham treatment in patients with long covid (HOT-LoCO): a randomised, placebo-controlled, double-blind, phase II trial

Objectives
To evaluate if 10 sessions of hyperbaric oxygen treatments (HBOTs) improve short- and long-term health related quality of life, symptoms and physical performance in long covid patients compared with placebo.

Design
Parallel, randomised, placebo-controlled, double-blind trial.

Setting
Single-centre, university hospital, Sweden.

Participants
Previously healthy subjects aged 18–60 years, diagnosed with long covid were included. We excluded pregnant women, patients with RAND-36 (role limitations due to physical health (RP) and physical functioning (PF)) above 70, diabetes, hypertension and contraindications for HBOT.

Interventions
Subjects were randomly assigned to 10 sessions of HBOT or sham (placebo) treatments over 6 weeks. HBOT involved 100% oxygen, 2.4 bar, 90 min, placebo medical air, 1.34–1.2 bar. Randomisation (1:1) was done electronically, in blocks stratified by sex and disease severity. Subjects and investigators were blinded to allocation.

Primary and secondary outcome measures
Primary endpoints were changes from baseline in RAND-36 PF and RP at 13 weeks. Efficacy was analysed on an intention-to-treat basis. Harms were evaluated according to the actual treatment given.

Results
Between 15 September 2021 and 20 June 2023, 80 subjects (65 women, 15 men) were enrolled and randomised (40 in each group). The trial is completed. The primary endpoint analysis included 79 subjects (40 in HBOT and 39 in control). At 13 weeks, both groups showed improvement, with no significant difference between HBOT and placebo in PF (least square mean difference between groups (LSD), 0.63 (95% CI –7.04 to 8.29), p=0.87) and RP (LSD, 2.35 (95% CI –5.95 to 10.66), p=0.57). Harms: 43 adverse events (AEs), most commonly cough and chest pain/discomfort, occurred in 19 subjects (49%) of the HBOT group and 38 AEs in 18 subjects (44%) of the placebo group, one serious AE in HBOT and one death in the placebo group.

Conclusions
10 HBOT sessions did not show more short-term benefits than placebo for long covid patients. Both groups improved, with a notable sex difference. HBOT has a favourable harm profile.

Trial registration number
ClinicalTrials.gov (NCT04842448), EudraCT (2021-000764-30). The trial was funded by Vetenskapsrådet (2022-00834), Region Stockholm (2020-0731, 2022-0674), Hjärt-Lungfonden and OuraHealth Oy.

Leggi
Aprile 2025

Tuberculosis service delivery challenges and their mitigations during the COVID-19 pandemic in Tanzania: a qualitative study

Objective
To describe challenges posed by COVID-19 on tuberculosis (TB) commodity supply, care cascade, active case finding and responses taken by healthcare workers (HCWs) and community health workers (CHWs) during the first year of the pandemic (March 2020 to February 2021).

Design
A qualitative descriptive study involving 25 in-depth interviews and 10 focus group discussions conducted in July 2022.

Setting
37 TB treatment facilities were purposively selected from seven regions due to high TB case notifications in 2019 and their provision of TB and COVID-19 services during the first year of the pandemic (March 2020 to February 2021).

Participants
Purposive selection of 58 HCWs and 55 CHWs who provided TB services in the first year of the COVID-19 pandemic.

Results
HCWs reported unusual stockouts and delayed receipt of GeneXpert cartridges and sputum containers. TB services faced a decline in client attendance, as clients were hesitant to undergo TB screening, sputum sample collection and contact tracing due to fear of contracting or being diagnosed with COVID-19 and subsequently being quarantined. To mitigate these challenges, HCWs used alternative containers for sputum sample collection, optimised GeneXpert cartridge use by prioritising GeneXpert testing for TB risk groups and diagnosed TB by microscopy, chest X-ray and sputum pooling method. Moreover, they extended drug refill schedules to minimise the risk of contracting COVID-19 in clinics. CHWs used mobile communication for client tracing and focused household visits on TB risk groups.

Conclusion
COVID-19 disrupted TB commodity availability and TB treatment-seeking behaviour. Adaptations like multi-month drug refills and optimised GeneXpert use supported the TB healthcare system’s resilience. While these adaptations offer valuable insights for strengthening TB service delivery, their effectiveness and sustainability require further evaluation. Thus, prospective studies could clarify their long-term impact. National Tuberculosis Program could consider adapting these practices postpandemic, with appropriate modifications to suit different contexts.

Leggi
Aprile 2025

COVID-19 Early Detection in Doctors and Healthcare Workers (CEDiD) study: a cohort study on the feasibility of wearable devices

Background
Infectious agents such as SARS-CoV-2 require strategies to contain outbreaks, particularly in hospitals where the spread of infection is most likely. Biometric monitoring of heart rate, temperature, oxygen saturations and sleep might provide important early warning signs for SARS-CoV-2. This study aimed to determine whether a smart medical device (E4 wristband) and a pulse oximeter used to continuously measure heart rate, skin temperature and oxygen saturation would predict the onset of SARS-CoV-2 infection.

Methods
A single-centre, prospective observational cohort of 30 healthcare workers (HCWs) working in areas at high risk for exposure to SARS-CoV-2 were enrolled. HCWs were tested for SARS-CoV-2 using RT-qPCR of daily self-administered swabs for 30 days. Each participant was asked to wear an E4 wristband to measure changes in their heart rate, skin temperature and sleep throughout the study.

Results
Nine (30%) HCWs (median (range) age of 39 (27–57) years) tested positive for COVID-19. No significant differences were found in the pre-infection and post-infection variations in the heart rate (p=0.31) or skin temperature (p=0.44). Seven of the nine positive subjects reported symptoms at some point during the study period: unusual fatigue (40%), headache (33%) and runny nose (22%) were the most frequent. Analysis of daily trends in observations demonstrated significant fluctuations in biometric parameters.

Conclusion
These results suggest that wearable technology might be useful in documenting signs of SARS-CoV-2 infection in exposed HCWs.

Trial registration number
NCT04363489.

Leggi
Aprile 2025

How did the context of COVID-19 affect the implementation and mechanisms of participatory learning and action to address type 2 diabetes? Mixed-methods research in rural Bangladesh

Objectives
Research indicates the effectiveness of participatory interventions to address rapid rises in type 2 diabetes in low-income countries. Understanding their transferability to different contexts is a priority. We aimed to analyse how the COVID-19 post-lockdown context and adjustments to a participatory learning and action intervention affected theorised mechanisms of effect in rural Bangladesh and to examine the broader implications of this context and intervention adjustments for developing optimal contexts for participatory interventions.

Design
Mixed methods using longitudinal qualitative and quantitative observation data, focus group discussions and interviews with group and community members and project personnel. We used descriptive content analysis, guided by realist evaluation research questions about context, implementation and mechanisms. We used team reflection to enhance the rigour of our analysis.

Setting
Cluster-randomised trial in Alfadanga upazila, Faridpur district, in the central region of Bangladesh. The intervention was implemented between January 2020 and December 2022, during the COVID-19 pandemic.

Participants
Participatory group members, community members and project personnel (n=32). Structured observations of participatory groups (n=1820) and unstructured observations of groups and their environments (n=15).

Interventions
Participatory learning and action community groups of men and women implemented by community-based facilitators.

Results
Due to COVID-19, the participatory learning and action (PLA) intervention was not implemented as planned, which had major effects on the time available to develop the intervention with communities. Communities learnt about diabetes and were motivated to address its causes at an individual level, but community action was a more challenging mechanism to trigger. The post-pandemic context made it difficult to build community rapport, and strategies to engage communities through home visits were challenging. Communities’ prior negative experience in working together and in working with non-governmental organisations led to low community cohesion and low motivation to address diabetes collectively. This also resulted in expectations that the implementing organisation would implement community actions and incentivise attendance at meetings. This misalignment of expectations further disabled relationship building, and community strategies addressing the social causes of diabetes were largely not enacted.

Conclusion
PLA has optimal effects when time is available to build trust and social cohesion. These are contextual elements and mechanisms that need to be activated to enable critical reflection and community action to develop an enabling environment to address type 2 diabetes.

Trial registration number
ISRCTN42219712.

Leggi
Aprile 2025

Association between smoking status and changes in health behaviours during the COVID-19 lockdown: a cross-sectional study in Israel

Objectives
To explore the association between smoking status (current vs former), changes in smoking habits (among current smokers only) and negative changes in dietary and physical activity habits during the initial COVID-19 lockdown in Israel.

Design
A secondary analysis of an online cross-sectional study (6 April 2020 to 28 April 2020). Dependent variables included deteriorations in dietary habits score and odds of reporting worsening of physical activity habits during the first COVID-19 lockdown. The study analysed the association between these variables and ‘smoking status’ (current vs former) and, within smokers, changes in smoking habits, using multivariate logistic and linear regression models. For changes in physical activity habits, there was a significant interaction with baseline physical activity levels (p=0.04), therefore, analysis was stratified accordingly.

Setting
Online data collection.

Participants
660 participants, current or former smokers in Israel, Hebrew speakers and ≥18 years old.

Primary outcomes
Self-reported negative changes in dietary habits and physical activity during the first COVID-19 lockdown.

Results
The sample (n=660) included 66.2% (n=437) current smokers and 33.8% (n=223) former smokers. Among current smokers, 43.5% (n=190) indicated an increase in their smoking habits. Of all respondents, 25% (n=170) reported a negative dietary change and 48% (n=192) spent less time engaging in physical activity, with 66% (n=437) reporting increased levels of stress. No significant association was found between smoking status and the dietary habits score in the multivariate linear regression (B=–0.046, CI –0.493 to 0.401, reference group: former smokers). This indicates that being a current smoker was associated with a non-significant 0.046 point decrease in the dietary habits score compared with former smokers. Similarly, no significant association was found between smoking status and odds of reporting worsening of physical activity, even after stratifying by baseline physical activity levels. Among participants who currently smoke, no significant association was found between changes in smoking habits and the dietary habits score (B=0.391, 95% CI –0.061 to 0.843, p=0.090, reference group: those who smoke the same or less) or with odds of reporting worsening of physical activity (OR=1.16, 95% CI 0.688 to 1.956, p=0.577, reference group: those who smoke the same or less).

Conclusion
Among current and former smokers, high rates of negative health habit changes were found, emphasising the need for interventions during future crises. Smoking status and/or changes in smoking habits among current smokers were not associated with negative changes in dietary and physical activity habits.

Leggi
Aprile 2025

Seroprevalence and demographic characteristics of SARS-CoV-2-infected residents of Kibera informal settlement during the COVID-19 pandemic in Nairobi, Kenya: a cross-sectional study

Objectives
To assess the prevalence of SARS-CoV-2 antibodies in the residents of Kibera informal settlement in Nairobi, Kenya, before vaccination became widespread, and explore demographic and health-related risk factors for infection.

Design
A cross-sectional study.

Setting
Kibera informal settlement, Nairobi, Kenya.

Participants
Residents of Kibera informal settlement between October 2019 and August 2021, age 1 year and above who reported no current symptoms of COVID-19.

Main outcome measures
Associations were determined between SARS-CoV-2 positive tests measured with one rapid test and two ELISAs and demographic and health-related factors, using Pearson’s 2 test. Crude OR and adjusted OR were calculated to quantify the strength of associations between variables and seropositive status.

Results
A total of 438 participants were recruited. Most (79.2%) were age 18–50 years; females (64.2%) exceeded males. More than one-third (39.1%) were unemployed; only 7.4% were in formal, full-time employment. Less than one-quarter (22.1%) self-reported any underlying health conditions. Nearly two-thirds (64.2%) reported symptoms compatible with COVID-19 in the previous 16 months; only one (0.23%) had been hospitalised with a reported negative COVID-19 test. 370 (84.5%) participants tested positive in any of the three tests. There was no significant difference in SARS-CoV-2 seropositivity across age, sex, presence of underlying health conditions, on medication or those ever tested for SARS-CoV-2. Multiple logistic regression analysis showed that COVID-19 symptoms in the previous 16 months were the only significant independent predictor of seropositivity (p=0.0085).

Conclusion
High SARS-CoV-2 exposure with limited morbidity was found in the residents of Kibera informal settlement. The study confirms other reports of high SARS-CoV-2 exposure with limited morbidity in slum communities. Reasons cited include the high infectious disease burden on the African continent, demographic age structure and underreporting due to limited testing and lack of access to healthcare services; genetic factors may also play a role. These factors require further investigation.

Leggi
Aprile 2025

Understanding symptom clusters, diagnosis and healthcare experiences in myalgic encephalomyelitis/chronic fatigue syndrome and long COVID: a cross-sectional survey in the UK

Objectives
This study aims to provide an in-depth analysis of the symptoms, coexisting conditions and service utilisation among people with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and long COVID. The major research questions include the clustering of symptoms, the relationship between key factors and diagnosis time, and the perceived impact of National Institute for Health and Care Excellence (NICE) guidelines on patient care.

Design
Cross-sectional survey using secondary data analysis.

Setting
Community-based primary care level across the UK, incorporating online survey participation.

Participants
A total of 10 458 individuals responded to the survey, of which 8804 confirmed that they or a close friend/family member had ME/CFS or long COVID. The majority of respondents were female (83.4%), with participants from diverse regions of the UK.

Primary and secondary outcome measures
Primary outcomes included prevalence and clustering of symptoms, time to diagnosis, and participant satisfaction with National Health Service (NHS) care, while secondary outcomes focused on symptom management strategies and the perceived effect of NICE guidelines.

Results
Fatigue (88.2%), postexertional malaise (78.2%), cognitive dysfunction (88.4%), pain (87.6%) and sleep disturbances (88.2%) were the most commonly reported symptoms among participants with ME/CFS, with similar patterns observed in long COVID. Time to diagnosis for ME/CFS ranged widely, with 22.1% diagnosed within 1–2 years of symptom onset and 12.9% taking more than 10 years. Despite updated NICE guidelines, only 10.1% of participants reported a positive impact on care, and satisfaction with NHS services remained low (6.9% for ME/CFS and 14.4% for long COVID).

Conclusions
ME/CFS and long COVID share overlapping but distinct symptom clusters, indicating common challenges in management. The findings highlight significant delays in diagnosis and low satisfaction with specialist services, suggesting a need for improved self-management resources and better-coordinated care across the NHS.

Leggi
Aprile 2025

Assessing the Impact of the COVID-19 Pandemic on Childhood Arterial Ischemic Stroke: An Unanticipated Natural Experiment

Stroke, Ahead of Print. BACKGROUND:The VIPS (Vascular Effects of Infection in Pediatric Stroke) II prospective cohort study aimed to better understand published findings that common acute infections, particularly respiratory viruses, can trigger childhood arterial ischemic stroke (AIS). The COVID-19 pandemic developed midway through enrollment, creating an opportunity to assess its impact.METHODS:Twenty-two sites (North America, Australia) prospectively enrolled 205 children (aged 28 days to 18 years) with AIS from December 2016 to January 2022, including 100 cases during the COVID-19 pandemic epoch, defined here as January 2020 to January 2022. To assess background rates of subclinical infection, we enrolled 100 stroke-free well children, including 39 during the pandemic. We measured serum SARS-CoV-2 nucleocapsid total antibodies (present after infection, not vaccination; half-life of 3–6 months). We assessed clinical infection via parental interview.RESULTS:The monthly rate of eligible AIS cases declined from spring through fall 2020, recovering in early 2021 and peaking in the spring. The prepandemic and pandemic cases were similar except pandemic cases had fewer clinical infections in the prior month (17% versus 30%;P=0.02) and more focal cerebral arteriopathy (20% versus 11%;P=0.09). Among pandemic cases, 26 of 100 (26%) had positive antibodies, versus 4 of 39 (10%) of pandemic-era well children (P=0.04). The first SARS-CoV-2 positive case occurred in July 2020. Ten of the 26 (38%) positive cases had a recent infection by parental report, and 7 of those 10 had received a diagnosis of COVID-19. Only 1 had multisystem inflammatory syndrome in children. Median (interquartile range) nucleocapsid IgG total levels were 50.1 S/CO (specimen to calibrator absorbance ratio; 26.9–95.3) in the positive cases and 18.8 (12.0–101) in the positive well children (P=0.33).CONCLUSIONS:The COVID-19 pandemic may have had dual effects on childhood AIS: an indirect protective effect related to public health measures reducing infectious exposure in general, and a deleterious effect as COVID-19 emerged as another respiratory virus that can trigger childhood AIS.

Leggi
Aprile 2025

Social, personal and medical factors influencing treatment delay for patients with primary glaucoma during the COVID-19 pandemic: a qualitative interview study

Background
Primary glaucoma patients faced many difficulties that affected their treatment during the COVID-19 pandemic. Glaucoma treatment often starts with prescription eye-drops. However, delays in ophthalmic therapy often occur due to poor awareness of the dangers of glaucoma, which subsequently leads to irreversible visual field defects and eventual blindness.

Objective
This study aimed to explore the social, personal and medical factors that contributed to barriers in the treatment of primary glaucoma during the COVID-19 pandemic, with the overarching goal of providing insights to develop measures that can identify the barriers of the treatment process and prevent consequent adverse outcomes.

Methods
We adopted a phenomenological approach and used purposive sampling to recruit 122 patients into our study. Face-to-face, semistructured, one-on-one interviews were conducted in a private office. The data were analysed using Colaizzi’s seven-step method. In cases where classification was difficult, consensus was reached among the three researchers who formed the core assessment team.

Results
A total of 122 glaucoma patients experienced delayed pharmaceutical treatment during the outbreak. Delays were longer among females and patients over 75 years old, highlighting that treatment delays were a significant issue for glaucoma patients during the COVID-19 pandemic, particularly for older females. Coding of the transcripts yielded three themes (eight subthemes): (1) the impact of social support on glaucoma pharmaceutical treatment: (a) the inability to seek pharmaceutical treatment alone and (b) online reservation and payment requirements; (2) the impact of personal reasons on glaucoma pharmaceutical treatment: (c) fear of being infected with COVID-19, (d) being infected with COVID-19 or coming into contact with COVID-19 patients, (e) being busy with work or life; (3) the impact of medical resources on glaucoma pharmaceutical treatment: (f) abnormal diagnosis and treatment processes, (g) insufficient medical manpower and (h) insufficient communication from medical staff.

Conclusions
To prevent medication delays and potential irreversible damage to the visual field in primary glaucoma patients during health crises, it is essential to further explore personalised strategies for coping with the impact of pandemics. Special attention should be given to glaucoma patients facing significant life burdens, such as the elderly and females, and efforts should be made to increase their awareness of the risks of glaucoma. Future studies could explore the feasibility of providing more support to glaucoma patients, such as online payment and appointment scheduling options, to reduce delays and alleviate patient anxiety.

Leggi
Marzo 2025