ABSTRACT
BackgroundWhilst timely clinical characterisation of infections caused by novel SARS-CoV-2 variants is necessary for evidence-based policy response, individual-level data on infecting variants are typically only available for a minority of patients and settings. MethodsHere, we propose an innovative approach to study changes in COVID-19 hospital presentation and outcomes after the Omicron variant emergence using publicly available population-level data on variant relative frequency to infer SARS-CoV-2 variants likely responsible for clinical cases. We apply this method to data collected by a large international clinical consortium before and after the emergence of the Omicron variant in different countries. ResultsOur analysis, that includes more than 100,000 patients from 28 countries, suggests that in many settings patients hospitalised with Omicron variant infection less often presented with commonly reported symptoms compared to patients infected with pre-Omicron variants. Patients with COVID-19 admitted to hospital after Omicron variant emergence had lower mortality compared to patients admitted during the period when Omicron variant was responsible for only a minority of infections (odds ratio in a mixed-effects logistic regression adjusted for likely confounders, 0.67 [95% confidence interval 0.61 - 0.75]). Qualitatively similar findings were observed in sensitivity analyses with different assumptions on population-level Omicron variant relative frequencies, and in analyses using available individual-level data on infecting variant for a subset of the study population. ConclusionsAlthough clinical studies with matching viral genomic information should remain a priority, our approach combining publicly available data on variant frequency and a multi-country clinical characterisation dataset with more than 100,000 records allowed analysis of data from a wide range of settings and novel insights on real-world heterogeneity of COVID-19 presentation and clinical outcome.
ABSTRACT
ISARIC (International Severe Acute Respiratory and emerging Infections Consortium) partnerships and outbreak preparedness initiatives enabled the rapid launch of standardised clinical data collection on COVID-19 in Jan 2020. Extensive global participation has resulted in a large, standardised collection of comprehensive clinical data from hundreds of sites across dozens of countries. Data are analysed regularly and reported publicly to inform patient care and public health response. This report, our 17th report, is a part of a series published over the past 2 years. Data have been entered for 800,459 individuals from 1701 partner institutions and networks across 60 countries. The comprehensive analyses detailed in this report includes hospitalised individuals of all ages for whom data collection occurred between 30 January 2020 and up to and including 5 January 2022, AND who have laboratory-confirmed SARS-COV-2 infection or clinically diagnosed COVID-19. For the 699,014 cases who meet eligibility criteria for this report, selected findings include: O_LImedian age of 58 years, with an approximately equal (50/50) male:female sex distribution C_LIO_LI29% of the cohort are at least 70 years of age, whereas 4% are 0-19 years of age C_LIO_LIthe most common symptom combination in this hospitalised cohort is shortness of breath, cough, and history of fever, which has remained constant over time C_LIO_LIthe five most common symptoms at admission were shortness of breath, cough, history of fever, fatigue/malaise, and altered consciousness/confusion, which is unchanged from the previous reports C_LIO_LIage-associated differences in symptoms are evident, including the frequency of altered consciousness increasing with age, and fever, respiratory and constitutional symptoms being present mostly in those 40 years and above C_LIO_LI16% of patients with relevant data available were admitted at some point during their illness into an intensive care unit (ICU), which is slightly lower than previously reported (19%) C_LIO_LIantibiotic agents were used in 35% of patients for whom relevant data are available (669,630), a significant reduction from our previous reports (80%) which reflects a shifting proportion of data contributed by different institutions; in ICU/HDU admitted patients with data available (50,560), 91% received antibiotics C_LIO_LIuse of corticosteroids was reported in 24% of all patients for whom data were available (677,012); in ICU/HDU admitted patients with data available (50,646), 69% received corticosteroids C_LIO_LIoutcomes are known for 632,518 patients and the overall estimated case fatality ratio (CFR) is 23.9% (95%CI 23.8-24.1), rising to 37.1% (95%CI 36.8-37.4) for patients who were admitted to ICU/HDU, demonstrating worse outcomes in those with the most severe disease C_LI To access previous versions of ISARIC COVID-19 Clinical Data Report please use the link below: https://isaric.org/research/covid-19-clinical-research-resources/evidence-reports/
ABSTRACT
BackgroundNew emerging infections have no known treatment. Assessing potential drugs for safety and efficacy enables clinicians to make evidence-based treatment decisions, and contributes to overall outbreak control. However, it is difficult to launch clinical trials in the unpredictable environment of an outbreak. We conducted a bibliometric systematic review for the 2009 influenza pandemic to determine the speed, and quality of evidence generation for treatments. This informs approaches to high-quality evidence generation in this and future pandemics. MethodsWe searched PubMed for all clinical data (including clinical trial, observational and case series) describing treatment for patients with influenza A(H1N1)pdm09 and ClinicalTrials.gov for research that aimed to enrol patients with the disease. Findings33869 treatment courses for patients hospitalised with A(H1N1)pdm09 were detailed in 160 publications. Most were retrospective observational studies or case series. 592 patients received treatment (or placebo) as participants in a registered interventional clinical trial with results publicly available. None of these registered trial results were available during the timeframe of the pandemic, and the median date of publication was 213 days after the Public Health Emergency of International Concern ended. InterpretationPatients were frequently treated for pandemic influenza with drugs not registered for this indication, but rarely under circumstances of high-quality data capture. The result was a reliance on use under compassionate circumstances, resulting in continued uncertainty regarding the potential benefits and harms of anti-viral treatment. Rapid scaling of clinical trials is critical for generating a quality evidence base during pandemics. FundingWellcome Trust.
ABSTRACT
IntroductionEarly during the SARS-CoV-2 pandemic, Australian emergency departments (EDs) have experienced an unprecedented surge in patients seeking screening for COVID-19. Understanding what proportion of these patients require screening, who can be safely screened in community based models of care, and who requires an emergency departments to care for them is critical for workforce and infrastructure planning across the healthcare system, as well as public messaging campaigns. MethodssIn this cross sectional survey, we screened patients presenting to a SARS-CoV-2 screening clinic in a tertiary hospital Emergency Department in Melbourne, Australia. We assessed the proportion of patients who met screening criteria; self-reported symptom severity; reasons why they came to the ED for screening; views on community-based models of care; and sources of information accessed about COVID-19. ResultsWe included findings from 1846 patients who presented to the Emergency Department (ED) for COVID-19 screening from 18th to 30th March 2020. Most patients (55.3%) did not meet criteria for screening and most (57.6%) had mild or no (13.4%) symptoms. The main reason for coming to the ED was being referred by a telephone health service (31.3%) and 136 (7.4%) said they tried to contact their GP but could not get an appointment. Only 47 (2.6%) said they thought the disease was too specialized for their GP to manage. Patients accessed numerous information sources, commonly government websites (68.4%) and other websites (51.3%) for COVID-19 information. Conclusionsif we are to ensure that emergency departments can cope with the likely surge in presentations requiring resuscitation or inpatient care COVID-19, we should strengthen access to alternative services to triage patients to prevent unnecessary presentations at health services, and to direct those who are well but require screening away from EDs.
