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1.
Vaccine ; 40(31): 4090-4097, 2022 Jul 29.
Article in English | MEDLINE | ID: covidwho-1867869

ABSTRACT

INTRODUCTION: The coronavirus disease 2019 (COVID-19) pandemic has evidenced the key role of vaccine design, obtention, production and administration to successfully fight against infectious diseases and to provide efficient remedies for the citizens. Although clinical trials were rapidly established during this pandemic, identifying suitable study subjects can be challenging. For this reason, the University Hospital Cologne established a volunteer registry for participation in clinical trials first in Germany, which has now been incorporated into the European VACCELERATE clinical trials network and grew to a European Volunteer Registry. As such, VACCELERATE's Volunteer Registry aims to become a common entry point for potential volunteers in future clinical trials in Europe. METHODS: Interested volunteers who would like to register for clinical trials in the VACCELERATE Volunteer Registry can access the registration questionnaire via http://www.vaccelerate.eu/volunteer-registry. Potential volunteers are requested to provide their current country and area of residence, contact information, including first and last name and e-mail address, age, gender, comorbidities, previous SARS-CoV-2 infection and vaccination status, and maximum distance willing to travel to a clinical trial site. The registry is open to both adults and children, complying with national legal consent requirements. RESULTS: As of May 2022, the questionnaire is available in 12 countries and 14 languages. Up to date, more than 36,000 volunteers have registered, mainly from Germany. Within the first year since its establishment, the VACCELERATE Volunteer Registry has matched more than 15,000 volunteers to clinical trials. The VACCELERATE Volunteer Registry will be launched in further European countries in the coming months. CONCLUSIONS: The VACCELERATE Volunteer Registry is an active single-entry point for European residents interested in COVID-19 clinical trials participation in 12 countries (i.e., Austria, Cyprus, Germany, Greece, Ireland, Lithuania, Norway, Portugal, Spain, Sweden and Turkey). To date, more than 15,000 registered individuals have been connected to clinical trials in Germany alone. The registry is currently in the implementation phase in 5 additional countries (i.e., Belgium, Czech Republic, Hungary, Israel and the Netherlands).


Subject(s)
COVID-19 , Clinical Trials as Topic , Patient Participation , Adult , COVID-19/epidemiology , COVID-19/prevention & control , Child , Europe/epidemiology , Humans , Registries , Volunteers
2.
JAMA Pediatr ; 176(3): 253-261, 2022 Mar 01.
Article in English | MEDLINE | ID: covidwho-1864300

ABSTRACT

IMPORTANCE: Childhood community-acquired pneumonia (CAP) is usually treated with 10 days of antibiotics. Shorter courses may be effective with fewer adverse effects and decreased potential for antibiotic resistance. OBJECTIVE: To compare a short (5-day) vs standard (10-day) antibiotic treatment strategy for CAP in young children. DESIGN, SETTING, AND PARTICIPANTS: Randomized double-blind placebo-controlled clinical trial in outpatient clinic, urgent care, or emergency settings in 8 US cities. A total of 380 healthy children aged 6 to 71 months with nonsevere CAP demonstrating early clinical improvement were enrolled from December 2, 2016, to December 16, 2019. Data were analyzed from January to September 2020. INTERVENTION: On day 6 of their originally prescribed therapy, participants were randomized 1:1 to receive 5 days of matching placebo or 5 additional days of the same antibiotic. MAIN OUTCOMES AND MEASURES: The primary end point was the end-of-treatment response adjusted for duration of antibiotic risk (RADAR), a composite end point that ranks each child's clinical response, resolution of symptoms, and antibiotic-associated adverse effects in an ordinal desirability of outcome ranking (DOOR). Within each DOOR rank, participants were further ranked by the number of antibiotic days, assuming that shorter antibiotic durations were more desirable. Using RADAR, the probability of a more desirable outcome was estimated for the short- vs standard-course strategy. In a subset of children, throat swabs were collected between study days 19 and 25 to quantify antibiotic resistance genes in oropharyngeal flora. RESULTS: A total of 380 children (189 randomized to short course and 191 randomized to standard course) made up the study population. The mean (SD) age was 35.7 (17.2) months, and 194 participants (51%) were male. Of the included children, 8 were Asian, 99 were Black or African American, 234 were White, 32 were multiracial, and 7 were of unknown or unreported race; 33 were Hispanic or Latino, 344 were not Hispanic or Latino, and 3 were of unknown or unreported ethnicity. There were no differences between strategies in the DOOR or its individual components. Fewer than 10% of children in either strategy had an inadequate clinical response. The short-course strategy had a 69% (95% CI, 63-75) probability of a more desirable RADAR outcome compared with the standard-course strategy. A total of 171 children were included in the resistome analysis. The median (range) number of antibiotic resistance genes per prokaryotic cell (RGPC) was significantly lower in the short-course strategy compared with the standard-course strategy for total RGPC (1.17 [0.35-2.43] vs 1.33 [0.46-11.08]; P = .01) and ß-lactamase RGPC (0.55 [0.18-1.24] vs 0.60 [0.21-2.45]; P = .03). CONCLUSIONS AND RELEVANCE: In this study, among children responding to initial treatment for outpatient CAP, a 5-day antibiotic strategy was superior to a 10-day strategy. The shortened approach resulted in similar clinical response and antibiotic-associated adverse effects, while reducing antibiotic exposure and resistance. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02891915.


Subject(s)
Community-Acquired Infections , Pneumonia , Anti-Bacterial Agents/adverse effects , Child , Child, Preschool , Community-Acquired Infections/drug therapy , Double-Blind Method , Female , Humans , Male , Outpatients , Pneumonia/drug therapy
3.
SSRN; 2022.
Preprint in English | SSRN | ID: ppcovidwho-333367

ABSTRACT

Introduction: The coronavirus disease 2019 (COVID-19) pandemic has demonstrated the key role that vaccines play against infectious diseases. Although clinical trials were rapidly established during this pandemic, identifying suitable study subjects can be challenging. For this reason, the University Hospital Cologne established a volunteer registry for participation in clinical trials first in Germany, which has now been incorporated into the European VACCELERATE clinical trials network and grew to a European Volunteer Registry. As such, VACCELERATE’s Volunteer Registry aims to become a common entry point for potential volunteers in future clinical trials in Europe. Methods: Interested volunteers who would like to register for clinical trials in the VACCELERATE Volunteer Registry can access the registration questionnaire via http://www.vaccelerate.eu/volunteer-registry. Potential volunteers are requested to provide their current country and area of residence, contact information, including first and last name and e-mail address, age, gender, comorbidities, previous SARS-CoV-2 infection and vaccination status, and maximum distance willing to travel to a clinical trial site. The registry is open to both adults and children, complying with national legal consent requirements. Results: As of January 2022, the questionnaire is available in 9 countries and 11 languages. Up to date, more than 35,000 volunteers have registered, mainly from Germany. Within the first year since its establishment, the VACCELERATE Volunteer Registry has matched 13,719 volunteers to clinical trials. The VACCELERATE Volunteer Registry will be launched in further European countries in the coming months. Conclusion: The VACCELERATE Volunteer Registry is an active single-entry point for European residents interested in COVID-19 clinical trials participation in 9 countries. To date, more than 13,000 registered individuals have been connected to clinical trials in Germany alone. The registry is currently in the implementation phase in 6 additional countries.

4.
Viruses ; 14(3)2022 03 17.
Article in English | MEDLINE | ID: covidwho-1753689

ABSTRACT

Coronavirus disease 2019 (COVID-19) has resulted in approximately 5 million deaths around the world with unprecedented consequences in people's daily routines and in the global economy. Despite vast increases in time and money spent on COVID-19-related research, there is still limited information about the factors at the country level that affected COVID-19 transmission and fatality in EU. The paper focuses on the identification of these risk factors using a machine learning (ML) predictive pipeline and an associated explainability analysis. To achieve this, a hybrid dataset was created employing publicly available sources comprising heterogeneous parameters from the majority of EU countries, e.g., mobility measures, policy responses, vaccinations, and demographics/generic country-level parameters. Data pre-processing and data exploration techniques were initially applied to normalize the available data and decrease the feature dimensionality of the data problem considered. Then, a linear ε-Support Vector Machine (ε-SVM) model was employed to implement the regression task of predicting the number of deaths for each one of the three first pandemic waves (with mean square error of 0.027 for wave 1 and less than 0.02 for waves 2 and 3). Post hoc explainability analysis was finally applied to uncover the rationale behind the decision-making mechanisms of the ML pipeline and thus enhance our understanding with respect to the contribution of the selected country-level parameters to the prediction of COVID-19 deaths in EU.


Subject(s)
COVID-19 , COVID-19/epidemiology , Europe/epidemiology , Humans , Machine Learning , Risk Factors , Support Vector Machine
5.
Glob Health Res Policy ; 6(1): 3, 2021 01 29.
Article in English | MEDLINE | ID: covidwho-1054852

ABSTRACT

BACKGROUND: Epidemiological data indicate that a large part of population needs to be vaccinated to achieve herd immunity. Hence, it is of high importance for public health officials to know whether people are going to get vaccinated for COVID-19. The objective of the present study was to examine the willingness of adult residents in Greece to receive a COVID-19 vaccine. METHODS: A cross-sectional was survey conducted among the adult general population of Greece between April 28, 2020 to May 03, 2020 (last week of lockdown), using a mixed methodology for data collection: Computer Assisted Telephone Interviewing (CATI) and Computer Assisted web Interviewing (CAWI). Using a sample size calculator, the target sample size was found to be around 1000 respondents. To ensure a nationally representative sample of the urban/rural population according to the Greek census 2011, a proportionate stratified by region systematic sampling procedure was used to recruit particpants. Data collection was guided through a structured questionnaire. Regarding willingness to COVID-19 vaccination, participants were asked to answer the following question: "If there was a vaccine available for the novel coronavirus, would you do it?" RESULTS: Of 1004 respondents only 57.7% stated that they are going to get vaccinated for COVID-19. Respondents aged > 65 years old, those who either themselves or a member of their household belonged to a vulnerable group, those believing that the COVID-19 virus was not developed in laboratories by humans, those believing that coronavirus is far more contagious and lethal compared to the H1N1 virus, and those believing that next waves are coming were statistically significantly more likely to be willing to get a COVID-19 vaccine. Higher knowledge score regarding symptoms, transmission routes and prevention and control measures against COVID-19 was significantly associated with higher willingness of respondents to get vaccinated. CONCLUSION: A significant proportion of individuals in the general population are unwilling to receive a COVID-19 vaccine, stressing the need for public health officials to take immediate awareness-raising measures.


Subject(s)
COVID-19 Vaccines/administration & dosage , COVID-19/prevention & control , Health Knowledge, Attitudes, Practice , Patient Acceptance of Health Care/statistics & numerical data , Adult , Aged , Cross-Sectional Studies , Female , Greece , Humans , Immunity, Herd , Interviews as Topic , Male , Middle Aged , Public Health
6.
Cmes-Computer Modeling in Engineering & Sciences ; 125(2):815-828, 2020.
Article | Web of Science | ID: covidwho-907540

ABSTRACT

Themodeling and risk assessment of a pandemic phenomenon such as COVID-19 is an important and complicated issue in epidemiology, and such an attempt is of great interest for public health decision-making. To this end, in the present study, based on a recent heuristic algorithm proposed by the authors, the time evolution of COVID-19 is investigated for six different countries/states, namely New York, California, USA, Iran, Sweden and UK. The number of COVID-19-related deaths is used to develop the proposed heuristic model as it is believed that the predicted number of daily deaths in each country/state includes information about the quality of the health system in each area, the age distribution of population, geographical and environmental factors as well as other conditions. Based on derived predicted epidemic curves, a new 3D-epidemic surface is proposed to assess the epidemic phenomenon at any time of its evolution. This research highlights the potential of the proposed model as a tool which can assist in the risk assessment of the COVID-19. Mapping its development through 3D-epidemic surface can assist in revealing its dynamic nature as well as differences and similarities among different districts.

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