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Purpose: There is limited research on individuals undergoing self-initiated health examinations, and the Werlabs cohort will be a base for such research., Participants: All individuals aged 18 or older who had undertaken a self-initiated health examination at Werlabs AB with at least one recorded value of creatinine or cholesterol in Sweden (from 1 January 2015 through 31 December 2023) was included. Medical history and anthropometric measurements were self-reported through an online questionnaire. We describe cohort baseline characteristics, demographic variables and cardiometabolic risk factors., Findings to Date: The study population includes 149 556 individuals who provided at least one health screening. The median (IQR) age was 43 (33-54) years and 54% were women. The most common self-reported chronic disease was hypertension (4.5%), followed by cardiovascular disease (0.9%) and 12.6% reported values of obesity. The prevalence was 2.1% for diabetes, 1.2% for kidney disease (including an estimated glomerular filtration rate of <60 mL/min/1.73 m 2 ), 57.8% for a low-density lipoprotein cholesterol level of >3.0 mmol/L and 4.1% for anaemia (haemoglobin <120 g/L and <130 g/L for women and men, respectively). Interestingly, 1.5% of the individuals had a glucose measurement of >7.0 mmol/L, without reporting a previous diagnosis of diabetes. In an analysis restricted to 621 individuals with recorded blood pressure data between the age of 40 and 70 years and without existing cardiovascular disease, diabetes or kidney disease, 35,4% were classified as high or very high cardiovascular risk according to the 2021 ESC guidelines on cardiovascular disease prevention and with lipid levels that made them eligible for lipid-lowering therapy., Future Plans: The Werlabs cohort comprises a rather healthy and young population that can provide opportunities for future studies on individuals undergoing self-initiated health examinations and has the potential to impact treatment of cardiometabolic risk factors., Competing Interests: Competing interests: HCA, NBF, DPA and OH are employed by Werlabs AB. LK is a former employee of Werlabs. NBF and DPA are shareholders in Werlabs AB. AN and KB have contributed with medical and scientific advice to Werlabs AB, and non-reimbursed (AN and KB) in the later years. PU declares no conflict of interest and all other authors declare no further conflicts of interest., (© Author(s) (or their employer(s)) 2025. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ Group.)

Background: Early in the COVID-19 pandemic, numerous clinical trials were initiated. Although concerns were raised regarding the quality of the trials, the eventual research output yielded from the trials remains unknown. The objective of this study was to include all clinical trials registered on ClinicalTrials.gov during the first 6 months of the pandemic and assess if and where their results had been reported, their completion and discontinuation rates, achieved enrolment and changes made to the primary outcome after trial registration., Methods: We included all interventional studies related to COVID-19 first registered on ClinicalTrials.gov between 1 January 2020 and 1 July 2020. We systematically searched for trial results, reported through 15 May 2023, in scientific publications, preprints and ClinicalTrials.gov. We assessed the achieved trial enrolment, trial discontinuation (reaching <90% of target enrolment), and whether the primary outcome had been changed as compared with the initial protocol registration., Results: The 775 clinical trials included in the analysis planned to enrol 238 933 (median (IQR) 120 (60, 304) patients; 355 (46%) of the trials had reported results, and 283 (36%) were published in a scientific journal. In the reported trials, the total enrolment was 95 332 (median (IQR) 105 (45, 222) patients. 186 (24%) trials were completed, and 169 (22%) trials were discontinued, with slow recruitment being the most stated reason for discontinuation (9% of all trials, although 30% of the discontinued trials did not report a reason). 117 (33%) of the reported trials had changed their primary outcome. In total, 157 (20%) trials were completed and published in a scientific journal, of which 105 enrolled ≥100 patients and 103 had not changed the primary outcome. 63 completed and published trials enrolled ≥100 patients and had not changed the primary outcome., Conclusions: Most clinical trials of COVID-19 registered at ClinicalTrials.gov during the first 6 months of the pandemic remained unreported or had been discontinued. Many of the trials whose results had been reported enrolled few patients and changed the primary outcome after trial registration., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: To assess the efficacy of inhaled ciclesonide in reducing the duration of oxygen therapy (an indicator of time to clinical improvement) among adults hospitalised with COVID-19., Design: Multicentre, randomised, controlled, open-label trial., Setting: 9 hospitals (3 academic hospitals and 6 non-academic hospitals) in Sweden between 1 June 2020 and 17 May 2021., Participants: Adults hospitalised with COVID-19 and receiving oxygen therapy., Intervention: Inhaled ciclesonide 320 µg two times a day for 14 days versus standard care., Main Outcome Measures: Primary outcome was duration of oxygen therapy, an indicator of time to clinical improvement. Key secondary outcome was a composite of invasive mechanical ventilation/death., Results: Data from 98 participants were analysed (48 receiving ciclesonide and 50 receiving standard care; median (IQR) age, 59.5 (49-67) years; 67 (68%) men). Median (IQR) duration of oxygen therapy was 5.5 (3-9) days in the ciclesonide group and 4 (2-7) days in the standard care group (HR for termination of oxygen therapy 0.73 (95% CI 0.47 to 1.11), with the upper 95% CI being compatible with a 10% relative reduction in oxygen therapy duration, corresponding to a <1 day absolute reduction in a post-hoc calculation). Three participants in each group died/received invasive mechanical ventilation (HR 0.90 (95% CI 0.15 to 5.32)). The trial was discontinued early due to slow enrolment., Conclusions: In patients hospitalised with COVID-19 receiving oxygen therapy, this trial ruled out, with 0.95 confidence, a treatment effect of ciclesonide corresponding to more than a 1 day reduction in duration of oxygen therapy. Ciclesonide is unlikely to improve this outcome meaningfully., Trial Registration Number: NCT04381364., Competing Interests: Competing interests: This study received non-financial support from COVIS Pharma (study drug donation). The authors have no conflict of interest to disclose., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: To assess the association of cardiometabolic risk factors with hospitalisation or death due to COVID-19 in the general population., Design, Setting and Participants: Swedish population-based cohort including 29 955 participants., Exposures: Cardiometabolic risk factors assessed between 2014 and 2018., Main Outcome Measures: Hospitalisation or death due to COVID-19, as registered in nationwide registers from 31 January 2020 through 12 September 2020. Associations of cardiometabolic risk factors with the outcome were assessed using logistic regression adjusted for age, sex, birthplace and education., Results: Mean (SD) age was 61.2 (4.5) and 51.5% were women. 69 participants experienced hospitalisation or death due to COVID-19. Examples of statistically significant associations between baseline factors and subsequent hospitalisation or death due to COVID-19 included overweight (adjusted OR (aOR) vs normal weight 2.73 (95% CI 1.25 to 5.94)), obesity (aOR vs normal weight 4.09 (95% CI 1.82 to 9.18)), pre-diabetes (aOR vs normoglycaemia 2.56 (95% CI 1.44 to 4.55)), diabetes (aOR vs normoglycaemia 3.96 (95% CI 2.13 to 7.36)), sedentary time (aOR per hour/day increase 1.10 (95% CI 1.02 to 1.17)), grade 2 hypertension (aOR vs normotension 2.44 (95% CI 1.10 to 5.44)) and high density lipoprotein cholesterol (aOR per mmol/L increase 0.33 (95% CI 0.17 to 0.65)). Statistically significant associations were not observed for grade 1 hypertension (aOR vs normotension 1.03 (95% CI 0.55 to 1.96)), current smoking (aOR 0.56 (95% CI 0.24 to 1.30)), total cholesterol (aOR per mmol/L increase 0.90 (95% CI 0.71 to 1.13)), low density lipoprotein cholesterol (aOR per mmol/L increase 0.90 (95% CI 0.69 to 1.15)) and coronary artery calcium score (aOR per 10 units increase 1.00 (95% CI 0.99 to 1.01))., Conclusions: In a large population-based sample from the general population, several cardiometabolic risk factors were associated with hospitalisation or death due to COVID-19., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)