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Background: Social distancing measures introduced during the COVID-19 pandemic have reduced admission rates for a variety of respiratory tract infections. We hypothesized that rates of asthma exacerbations would decline following the national lockdown introduced on March 12, 2020, in Denmark. Aim(s): To determine weekly rates of in- and out of hospital asthma exacerbations prior to and during the national lockdown. Method(s): All persons >18 years with at least one outpatient hospital contact with asthma as the primary diagnosis from January 1, 2013, to December 31, 2017, were included. Weekly asthma exacerbation rates from January 1, 2018, to May 22, 2020, were assessed. An interrupted time-series (ITS model) with March 12, 2020, as the point of interruption was conducted. Result(s): A total of 38,225 patients with asthma were identified. The ITS model showed no immediate changes in exacerbation rates during the first week after March 12, 2020. However, there was a significant decrease in weekly exacerbation rates in the following 10 weeks (change in trend for exacerbations requiring hospitalisation: -0.75 [95% CI -1.39,-0.12], (p < 0.02) corresponding to a reduction of about 1 exacerbation per year per 100 patients in the cohort, and a change in trend for all asthma exacerbations: -12.2 [95% CI -19.1,-5.4], p<0.001 corresponding to a reduction of 16.5 exacerbations per year per 100 patients in the cohort). Conclusion(s): The introduction of the social distancing measures in Denmark on March 12, 2020, did not lead to an immediate reduction in asthma exacerbation rates, however a gradual decline in exacerbation rates during the following 10-weeks period was observed.
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Introduction: The first case of coronavirus disease 2019 (COVID-19) disease caused by severe acute respiratory syndrome coronavirus-2 occurred in Denmark on 27 February 2020. On 10 March, the first case of COVID-19 pneumonia was admitted to Hvidovre Hospital.
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BACKGROUND: The coronavirus disease 2019 (COVID-19) pandemic has resulted in millions of deaths and overburdened healthcare systems worldwide. Systemic low-dose corticosteroids have proven clinical benefit in patients with severe COVID-19. Higher doses of corticosteroids are used in other inflammatory lung diseases and may offer additional clinical benefits in COVID-19. At present, the balance between benefits and harms of higher vs. lower doses of corticosteroids for patients with COVID-19 is unclear. METHODS: The COVID STEROID 2 trial is an investigator-initiated, international, parallel-grouped, blinded, centrally randomised and stratified clinical trial assessing higher (12 mg) vs. lower (6 mg) doses of dexamethasone for adults with COVID-19 and severe hypoxia. We plan to enrol 1,000 patients in Denmark, Sweden, Switzerland and India. The primary outcome is days alive without life support (invasive mechanical ventilation, circulatory support or renal replacement therapy) at day 28. Secondary outcomes include serious adverse reactions at day 28; all-cause mortality at day 28, 90 and 180; days alive without life support at day 90; days alive and out of hospital at day 90; and health-related quality of life at day 180. The primary outcome will be analysed using the Kryger Jensen and Lange test adjusted for stratification variables and reported as adjusted mean differences and median differences. The full statistical analysis plan is outlined in this protocol. DISCUSSION: The COVID STEROID 2 trial will provide evidence on the optimal dosing of systemic corticosteroids for COVID-19 patients with severe hypoxia with important implications for patients, their relatives and society.