|drug1624||Low nitrite/NDMA meals Wiki||0.24|
|drug13||10% Povidone-iodine nasal decolonization swab plus 0.12% CHG oral rinse Wiki||0.24|
|drug1253||High nitrite/NDMA meals Wiki||0.24|
|drug1300||Hydroxychloroquine SAR321068 Wiki||0.24|
|drug1866||Nigella sativa Wiki||0.24|
|drug2835||Tears swab Wiki||0.24|
|drug207||Angiotensin 1-7 Wiki||0.24|
|drug1130||Follow up Wiki||0.17|
|D010510||Periodontal Diseases NIH||0.24|
|D012893||Sleep Wake Disorders NIH||0.14|
|D000163||Acquired Immunodeficiency Syndrome NIH||0.14|
|D018352||Coronavirus Infections NIH||0.12|
|D045169||Severe Acute Respiratory Syndrome NIH||0.11|
|D008107||Liver Diseases NIH||0.08|
|D015658||HIV Infections NIH||0.07|
|D003141||Communicable Diseases NIH||0.04|
|D016638||Critical Illness NIH||0.03|
|D011024||Pneumonia, Viral NIH||0.03|
|D014777||Virus Diseases NIH||0.03|
There are 18 clinical trials
COVID-19 may cause another world-wide epidemic. This study is divided into 2 arms: (1) Prospective longitudinal observational study involving patients with laboratory-confirmed COVID-19 and (2) Retrospective study on patients with laboratory-confirmed COVID-19. Arm 1: We will collect EDTA blood, stool samples, rectal swab, urine, saliva, and specimens from upper respiratory tract (nasopharyngeal aspirate or flocked swab), and lower respiratory tract (sputum or tracheal aspirate) on daily, alternate day, or weekly basis as appropriate. Arm 2: The remainder of specimens that were submitted for laboratory investigation as part of clinical management will be retrieved. Those specimens will only be used after all clinically indicated testing and confirmation procedures have been completed. Assistance from the Public Health Laboratory Service, Department of Health, will be invited to retrieve samples as well as participate in this study. Patients hospitalized for pneumonia in medical wards and ICU at the Prince of Wales Hospital tested negative for COVID-19 will be recruited as controls. Understanding the clinical, virological, microbiological and immunological profiles of this infection is urgently needed to facilitate its management and control.
Description: Patients' treatment and management during hospitalization.Measure: Clinical Time: 6 months
Description: Serial viral load changes during hospitalization.Measure: Virological Time: 6 months
Description: Alterations in fecal microbiota composition (including virome, bacteria and fungi) in COVID-19 patients compared with healthy controls.Measure: Microbiological Time: 6 months
Currently, limited data is available about patients with HIV in the context of the COVID-19 pandemic. People with HIV who have not achieved viral suppression through antiretroviral treatment may have a compromised immune system that leaves them vulnerable to infections and disease progression. However, little is known about the presentation and clinical outcomes of patients with HIV and SARS-CoV-2. Our aim is to characterize the clinical presentation and disease course of COVID-19 in patients with HIV.
Description: COVID-19 related death among patients with HIV and COVID-19Measure: Mortality Time: 30 days
Description: Percentage of patients who required hospitalizationMeasure: Frequency of patients requiring hospital admissions Time: 30 days
Description: Percentage of patients who required ICU admissionMeasure: Frequency of patients requiring ICU admissions Time: 30 days
Description: Percentage of patients who required respiratory support (new oxygen use, non-invasive ventilation,or invasive ventilation)Measure: Frequency of respiratory support use Time: 30 days
Description: Percentage of patients who developed acute kidney injury defined as increase in baseline creatinine, or use of renal replacement therapyMeasure: Frequency of kidney injury Time: 30 days
Description: Percentage of patients who developed liver injury defined as increase in baseline ALTMeasure: Frequency of liver injury Time: 30 days
Since December 2019, a new agent, the SARS-Cov-2 coronavirus has been rapidly spreading from China to other countries causing an international outbreak of respiratory illnesses named COVID-19. In France, the first cases have been reported at the end of January with more than 60000 cases reported since then. A significant proportion (20-30%) of hospitalized COVID-19 patients will be admitted to intensive care unit. However, few data are available for this special population in France. We conduct a large observational cohort of ICU suspected or proven COVID-19 patients that will enable to describe the initial management of COVID 19 patients admitted to ICU and to identify factors correlated to clinical outcome.
Description: Mortality at day 28Measure: Mortality at day 28 Time: day 28
Description: severe complications (pulmonary embolism, acute kidney injury, myocarditis, cardiac arrest, liver failure, ventilator associated pneumonia) Yes / NoMeasure: severe complications Time: up to day 28
Description: Delay in imaging in hoursMeasure: Imaging Time: day 1
Description: delay in microbiological diagnosis in hoursMeasure: Delay in Microbiological diagnosis Time: day 1
Description: Antiviral therapy Yes / noMeasure: Antiviral therapy Time: up to day 28
Description: Antibiotic therapy Yes / NoMeasure: Antibiotic therapy Time: day 28
Description: Covid-19 treatments Yes / NoMeasure: Covid-19 treatments Time: up to day 28
Description: numberMeasure: Patients receiving renal replacement therapy Time: up to day 28
Description: numberMeasure: Patients receiving mechanical ventilation Time: up to day 28
Description: Patient alive at day 28 : yes / NoMeasure: Vital status Time: day 28
Multicenter observational/registry study of the clinical features and outcomes of critically ill patients with COVID-19.
The current outbreak of COVID-19 pandemic has been marked by severe psychological problems. People around the world experienced a similarly frightening public health emergency, on a global scale, with the spread of this corona infection. (1) Studies of the Severe Acute Respiratory Syndrome (SARS) outbreaks that occurred in Canada, Taiwan, and Hong Kong found that the enormous emotional burden carried by those health care workers who were on the front lines of the battle against the disease led to psychological morbidity like anxiety, stress and even further leads to Post traumatic stress disorder. The initial phase of the COVID-19 outbreak in China in 2020 also reported more than half of the respondents rated the psychological impact as moderate-to-severe, and about one-third reported moderate-to-severe anxiety in general population.(2) - The chances of Fear, anxiety and stress are even higher in Individuals with preexisting liver disease as they have restriction of services for getting treatment. Moreover, they can have the following additional issues: - Fear of severe form of Corona present (as presented in most of the media and research) - Fear of dying - Added uncertainty - Family members also worried
Description: Following questionnaire will be used For Fear of COVID-19: FEAR OF COVID-19 Scale Fear of Coronavirus-19 Scale: The participants indicate their level of agreement with the statements using a five-item Likert-type scale. Answers included "strongly disagree," "disagree," "neither agree nor disagree," "agree," and "strongly agree". The minimum score possible for each question is 1, and the maximum is 5. A total score is calculated by adding up each item score (ranging from 7 to 35). The higher the score, the greater the fear of cororonavirus-19.Measure: Assessment of the fear levels during the COVID-19 disease pandemic among patients with Liver disease (currently under treatment from ILBS) Time: Day 0
Description: Following questionnaire will be used o For, anxiety: DASS - 21 Scale Depression, Anxiety and Stress Scale - 21 Items (DASS-21) Depression Anxiety Stress Scale (DASS)-21: The DASS-21 is based on three subscales of depression, stress, and anxiety and each subscale consists of seven questions each. Each subscale comprises of seven statements regarding how the test subject was feeling over the last week and four responses ranging from 0- did not apply to me at all, 1- applied to me some of the time, 2- applied to me for a considerable amount of time to 3- applied to me very much/most of the time. The scoring system is of the Likert type and the total score for each subscale gives the severity of that very symptom which has a range from 0 to 21 for each subscale.Measure: Assessment of the anxiety levels during the COVID-19 disease pandemic among patients with Liver disease (currently under treatment from ILBS) Time: Day 0
Description: Following questionnaire will be used o Stress levels: DASS - 21 Scale Depression Anxiety Stress Asymptomatic ≤4 ≤3 ≤7 Symptomatic >4 >3 >7Measure: Assessment of the stress levels during the COVID-19 disease pandemic among patients with Liver disease (currently under treatment from ILBS) Time: Day 0
Description: Following questionnaire will be used o For Fear of COVID-19: FEAR OF COVID-19 ScaleMeasure: Association between presence of Liver disease and fear levels Time: Day 0
Description: Following questionnaire will be used o For, anxiety levels: DASS - 21 Scale Depression, Anxiety and Stress Scale - 21 Items (DASS-21) Higher Scores mean worse conditionMeasure: Association between presence of Liver disease and anxiety levels Time: Day 0
Description: Following questionnaire will be used o For stress levels: DASS - 21 Scale Depression, Anxiety and Stress Scale - 21 Items (DASS-21) Higher Scores mean worse condition.Measure: Association between presence of Liver disease and stress levels Time: Day 0
Description: Higher Scores mean worse conditionMeasure: Correlation between Fear and Child-Turcotte-Pugh Score Time: Day 0
Description: Higher Scores mean worse conditionMeasure: Correlation between anxiety and Child-Turcotte-Pugh Score Time: Day 0
Description: Higher Scores mean worse conditionMeasure: Correlation between stress and Child-Turcotte-Pugh Score Time: Day 0
Description: Higher Scores mean worse conditionMeasure: Correlation between fear and Model for End Stage Liver Disease Score Time: Day 0
Description: Higher Scores mean worse conditionMeasure: Correlation between anxiety and Model for End Stage Liver Disease Score Time: Day 0
Description: Higher Scores mean worse conditionMeasure: Correlation between stress and Model for End Stage Liver Disease Score Time: Day 0
This is a prospective multicenter cohort study. The question arises as to whether treatment with protease inhibitors (PIs) could have a preventive role for COVID-19 infection, especially since patients living with HIV (PLWHIV) have not been described as more at risk of developing COVID-19 infection. The aim of our study will therefore be to assess the impact of long-term protease inhibitors in PLWHIV on the incidence of COVID-19.
Description: Occurrence of COVID-19 infection during the epidemics (M0, M1) in both study groupsMeasure: Comparison of the incidence of COVID-19 infection in PLWHIV treated with long-term antiretroviral drugs including a protease inhibitor and those without a protease inhibitor Time: 1 month
Description: Percentage of positive serological tests at the end of the epidemics in both study groupsMeasure: Determination of the seroprevalence of COVID-19 infection in both groups of the study Time: 6 months
Description: Proportion of severe forms in both study groupsMeasure: Comparison of the severity of COVID-19 infection symptoms in both groups of the study. Time: 6 months
Description: Statistical association between a risk factor and the occurrence of COVID-19 infection in both study groupsMeasure: Identification of potential risk factors for COVID-19 infection in HIV patients treated with protease inhibitor or without protease inhibitor Time: 6 months
This study aims at investigating handwashing behavior during COVID-19 pandemic. It was hypothesized that social-cognitive and emotional predictors as well as COVID-19 morbidity and mortality rates within the country would be associated with handwashing behavior in the general population of adults in 14 countries.
Description: The 12-item self-report measure of adherence to handwashing guidelines across situations (e.g., after visiting public spaces, after touching garbage, etc.) based on the guidelines issued by the World Health Organization and the Centers for Disease Control and Prevention. The responses are provided on a 4-point scale, ranging from 1 (strongly disagree) to 4 (strongly agree). Higher scores indicate better outcomes (the higher level of adherence to handwashing guidelines).Measure: Handwashing adherence Time: 1 month
Description: The 1-item self-report measure of the frequency of handwashing (for at least 20 seconds, all surfaces of the hands) daily. The responses are provided on a 4-point scale, ranging from 1 (less than once) to 5 (more than 10 times). Higher scores indicate better outcomes (the higher frequency of handwashing).Measure: Frequency of handwashing Time: 1 month
Description: 4 self-efficacy questionnaire items; mean item score ranging from 1 to 4, higher scores indicate stronger self-efficacyMeasure: Self-efficacy Time: 1 month
Description: 3 questionnaire items to assess risk perception; mean item score ranging from 1 to 5, higher scores indicate higher risk perceptionMeasure: Risk perception Time: 1 month
Description: 4 items assessing positive (1 item) and negative (1 items) outcome expectancies; mean item scores ranging from 1 to 4, higher scores indicate more positive outcome expectanciesMeasure: Outcome expectancy Time: 1 month
Description: 2 questionnaire items assessing intention to adhere to handwashing recommendations; mean item scores ranging from 1 to 4, higher scores indicate stronger intention to wash hands (for at least 20 seconds, all surfaces of the hands)Measure: Intention Time: 1 month
Description: 2 questionnaire items assessing action planning (1 item) and coping planning (1 item); mean item scores ranging from 1 to 4, higher scores indicate a higher level of self-reported planningMeasure: Planning Time: 1 month
Description: 3 questionnaire items assessing a facet of action control, namely self-monitoring; mean item scores ranging from 1 to 4, higher scores indicate a higher level of self-reported monitoring of handwashing behaviorMeasure: Action control Time: 1 month
Description: 1 questionnaire item assessing perceptions of handwashing as an effective means of preventing coronavirus SARS-CoV-2 infection; item scores ranging from 1 to 4, higher scores indicate a higher level of perceived effectiveness of hand hygieneMeasure: Perceived effectiveness of hand hygiene Time: 1 month
Description: 7-item self-report scale (Generalized Anxiety Disorder, GAD-7) scale to assess anxiety symptoms; mean item scores ranging from 1 to 4, higher scores indicate a higher level of generalized anxietyMeasure: Anxiety Time: 1 month
Description: The daily cumulative numbers for COVID-19 morbidity and mortality in the study countries. Published daily as the Situation Report by World Health Organization, starting on 21 January 2020. Higher numbers indicate the higher cumulative COVID-19 morbidity and mortality rates in the country.Measure: Country-level COVID-19 morbidity and mortality rates Time: 60 days
Hospital staff and emergency personnel are expected to suffer impaired psychological outcomes during a pandemic in terms of Quality of Life, anxiety, depression or other outcomes. The Covid-19 pandemic is a threat for both somatic and psychological health, therefore the impact of the impairment of this event on psychological parameters has to be assessed.
Description: Validated 20-items questionnaire for PTSDMeasure: PCL5 Questionnaire Time: 14 days
Description: The Brief Symptom Inventory (BSI) is a 53-item screener for mental health problems with 9 subscales.Measure: BSI - Brief symptom inventory Time: 14 days
Description: Instrument for psychological diagnostics, able to test the severity of mental disorders and the success of their treatmentMeasure: PHQD Time: 14 days
Description: Qol Questionnaire, assessed QoL with respect to the individual's perceptions in the context of culture and value systems.Measure: WHO - QoL BREF Time: 14 days
Description: The State-Trait Anger Expression Inventory is used to measure the expressions & control of angerMeasure: STAXI Time: 14 days
Description: The AUDIT questionnaire is designed to help in the self assessment of alcohol consumptionMeasure: AUDIT questionnaire Time: 14 days
To compare various treatments provided to positive COVID-19 patients at locations across the OSF Ministry. Provide the opportunity to compare the effectiveness of various treatments and treatment timelines provided to specific cohorts of patients that have the potential to impact future treatment plans for COVID-19 patients and/or future research hypotheses.
This prospective observational study examines the effects of the Covid-19 pandemic on oral health, taking psychosocial factors into account, and the possible impact of a high periodontitis risk on the severity of the need for treatment in Covid-19 patients.
Description: The survey consists of validated and unvalidated items giving the opportunity to assess periodontitis risk, psychosocial stress, anxiety, depression and oral health related quality of life as well as questions focusing on experiences of the covid-19 pandemic.Measure: How do people assess their oral health-related quality of life in times of the Covid-19 pandemic? Time: 08.05.2020-31.07.2020
Description: The survey consists of validated and unvalidated items giving the opportunity to assess periodontitis risk, psychosocial stress, anxiety, depression and oral health related quality of life as well as questions focusing on experiences of the covid-19 pandemic.Measure: Does the periodontitis risk have an influence on the severety of the Covid-19 disease and its' treatment? Time: 08.05.2020-31.07.2020
Description: The survey consists of validated and unvalidated items giving the opportunity to assess periodontitis risk, psychosocial stress, anxiety, depression and oral health related quality of life as well as questions focusing on experiences of the covid-19 pandemic.Measure: Do psychosocial stress factors in times of the Covid-19 pandemic have an impact on their oral health related quality of life? Time: 08.05.2020-31.07.2020
This study will describe the recovery process of patients undergoing cardiac surgery during the covid-19 pandemic. This will focus on hemodynamic failure and organ dysfunction after surgery. Capturing real-world data and sharing international experience will inform the management of this complex group of patients who undergo surgery throughout the COVID-19 pandemic, improving their clinical care. This investigator-led, non-commercial, non-interventional does not collect any patient identifiable information.
Description: The VIS score correlates with mortality after cardiac surgery and reflects the degree of patient hemodynamic failure. This score is calculated as follows: ISR = Dobutamine dose in g/kg/min + 100 times the Adrenaline dose in g/kg/min + 100 times the Noradrenaline dose in g/kg/min + 10,000 times the Vasopressin dose in U/kg/min.Measure: Highest VIS (Vasoactive-Inotropic Score) in the first 12 hours postoperatively. Time: 12 hours post-operatively
Description: Prospective assessment of ICU outcomes until all included patients were discharged from ICUMeasure: Post-operative organ failure Time: 5 days post-operatively
Description: Prospective assessment of ICU outcomes until all included patients.Measure: Post-operative outcome Time: 28 days post-operatively
The outbreak of coronavirus was categorized as a global pandemic in March 2020. The Danish government recommends social distancing during the COVID-19 pandemic. Long-term social distancing and fear of disease can lead to anxiety, depression and the feeling of loneliness. All these factors might affect the quality of life (QoL). The aim of this study is to investigate the overall QoL for patients with cancer during the COVID-19 pandemic with special focus on emotional functioning.
Description: EORTC (European Organisation for Research and Treatment of Cancer) QLQ-C30 (Quality of Life Questionnaire core 30) - The QLQ-C30 is a standardized cancer-specific 30-itemed instrument. Scores are transformed linearly to a zero to 100 scale. A higher score on the functional scale and the global Health related Quality of Life indicates better functioning. In the current study, the items addressing global quality of life and health: "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" will be used to get a pure expression of QoL. The EORTC QLQ-C30 scores in this study will be compared with QoL for Danish Cancer patients in the period before COVID-19 (https://www.cancer.dk/dyn/resources/File/file/3/8373/1574778638/kraeftens-bekaempelses-barometerundersoegelse-2019.pdf). Results on overall QoL is listed on page 36.Measure: Overall Quality of Life Time: One measurement of EORTC QLQ-C30 and a survey created for the purpose will be performed through study completion, an average of 1 months
The current project is a prospective, multicentric cohort study aiming at a multidisciplinary assessment (pulmonary, cardiometabolic, sleep and mental health) of the consequences of infection by SARS-CoV-2, 3 months after the diagnosis in order to better characterize these complications. 400 patients with a positive diagnosis of SARS-CoV-2 will be included in the study 3 months after their diagnosis: They will be followed at 6 months, 1 year, 3 years, and 5 years, as function of their after-effects discovered at 3 months and their evolution.
Description: Pulmonary function 3 months after COVID diagnosis, as measured by diffusion capacity of carbon monoxide (DLCO)Measure: Diffusion Capacity for Carbon Monoxide (CO) 3 months after COVID diagnosis Time: 3 months after COVID diagnosis
Description: Prevalence of Sleep Disordered Breathing, as measured by polysomnographyMeasure: Prevalence of Sleep Disordered Breathing (SDB) 3 months after COVID diagnosis Time: 3 months after COVID diagnosis
Description: Prevalence of sleep disorders, as measured by polysomnographyMeasure: Prevalence of sleep disorders 3 months after COVID diagnosis Time: 3 months after COVID diagnosis
Description: Prevalence of ventilatory impairments measured by pulmonary function testsMeasure: Prevalence of ventilatory muscle function impairments, 3 months after COVID diagnosis Time: 3 months after COVID diagnosis
Description: Prevalence of cardiac impairments measured by cardiac echographyMeasure: Prevalence of cardiac impairments 3 months after COVID diagnosis Time: 3 months after COVID diagnosis
Description: Pulmonary function as measured by diffusion capacity of carbon monoxide (DLCO)Measure: Follow-up of pulmonary diffusion capacity of carbon monoxide Time: From Baseline (3 months after COVID diagnosis) to 5 years
Description: Assessment of SDB treatments adherence will be monitored in hours/nightMeasure: Follow-up of sleep disorders treatment compliance Time: From Baseline (3 months after COVID diagnosis) to 5 years
Description: Assessment of SDB treatments efficacy will be based on the residual AHI index (Apnea Hypopnea/hour) under treatmentMeasure: Follow-up of sleep disorders treatments efficacy Time: From Baseline (3 months after COVID diagnosis) to 5 years
Description: HLA alleles will be assessed as a component of genetic immune capacityMeasure: HLA alleles aspect of COVID clinical presentation Time: 3 months after COVID diagnosis
Description: KIR loci will be assessed as a different component of genetic immune capacityMeasure: KIR loci aspect of COVID clinical presentation Time: 3 months after COVID diagnosis
Description: metabolome expression in seraMeasure: metabolomic aspect of COVID clinical presentation Time: 3 months after COVID diagnosis
As dentists begin reopening their practices during a global pandemic, the risk of COVID-19 infection that dentists face in providing dental care remains unknown. Estimating the occupational risk of COVID-19, and producing evidence on the types of infection control practices and dental practices that may affect COVID-19 risk, is therefore imperative. The goal of the proposed study is to understand U.S.-based dentists' health and dental-practice reactions to COVID-19. To estimate this, U.S-based dentists will be surveyed monthly. These findings could be used to describe the prevalence and incidence of COVID-19 among dentists, determine what infection control steps dentists take over time, and estimate whether infection control adherence in dental practice is related to COVID-19 incidence.
Description: COVID-19 case as confirmed by clinician and/or detection of SARS-CoV-2 RNA or a specific antigen in a clinical specimenMeasure: COVID-19 probable or confirmed case Time: 18 months
Description: Assessed using the Patient Health Questionnaire for Depression and Anxiety (PHQ-4). Two items scored 0 to 3 (total score of 0-6), with higher numbers indicating greater anxiety.Measure: Anxiety Time: 12 months
Description: Assessed using the Patient Health Questionnaire for Depression and Anxiety (PHQ-4). Two items scored 0 to 3 (total score of 0-6), with higher numbers indicating greater depressive symptoms.Measure: Depression Time: 12 months
Description: Self-reports of infection control efforts in the respondents' primary dental practicesMeasure: Dental practice infection control efforts Time: 12 months
Description: Self-reports of personal protective equipment useMeasure: Dentists' use of personal protective equipment Time: 12 months
The study cohort will be enrolled among all Humanitas group employees (including ICH, Humanitas University and Gavazzeni), and two validation cohorts. Participants will be asked consent for the research use of blood, pharyngeal swab, and for those hospitalized for COVID-19, also for the bronchoalveolar lavage and fecal samples. Biological samples will be used to perform cellular, microbial and molecular analyses aimed at better understanding the disease pathogenesis and the individual differences in susceptibility to the disease.
Description: COVID-19 infection will be assessed by serological analysis of the presence of IgG anti-Covid-19 antibodies, an a subsequent pharyngeal swab. Symphtoms and possible hospitalization will be considered in clinical response.Measure: Clinical response to COVID-19 Time: 36 months
Description: PBMC analysis by FACS to investigate the immunophenotype and correlate it to the clinical outcome (symptoms aggressiveness).Measure: Immunological response to COVID-19 Time: 36 months
Description: Genetic variants analysis potentially related with COVID-19 susceptibility/severity in different subgroups of patients, ranging from individuals positive for the virus but asymptomatic to individuals affected by COVID-19 with ARDS requiring admission to ICUMeasure: Genetic predisposition to COVID-19 Time: 36 months
Description: Microbiota analysis (using 16S rDNA sequencing technology) of residual BAL, pharyngeal swab, plasma and saliva/sputum to evaluate whether different microbial or metabolome profiles are associated to worsen disease or to protectionMeasure: Microbiome-related response to COVID-19 Time: 36 months
SARS-CoV-2 is the novel coronavirus responsible for COVID-19, coronavirus disease 2019. This new coronavirus was first detected in Wuhan, China in late December 2019. According to WHO, the incidence rate of COVID-19 is prominent among adults and elderly people, reaching so far >2 million cases globally. Meanwhile, confirmed death cases reached >126 thousands of reported cases in 185 countries and still increasing. We anticipate that immunological differences among COVID19-infected patients might be a reason behind the variation of patient outcomes. Therefore, we intend to investigate cellular and humoral immune responses of COVID19-positive patients, and we claim to discover new indicators of patients' prognosis. Our target population includes three categories of patients staying at ICU, HMC (COVID19-positive vs. COVID19-negative vs. healthy control). Throughout their ICU stay, multiple blood samples will be screened for leukocytes surface markers, leukocytes' production of certain molecules, and circulating cytokines/chemokines/checkpoint inhibitors. Their plasma/serum will be used as well for immune proteomics, metabolomics, and other serological tests. Such parameters can provide the more comprehensive status of COVID19-infected patients at infection onset, during treatment intake, and at recovery or relapse stage. Following analysis, the main prospective outcome of this study is to identify the most reflective markers of COVID19-positive patients' outcomes.
Description: A descriptive analysis of the innate and adaptive immune cells (phenotypically and functionally), along with circulating pro- and anti-inflammatory cytokines, and the dynamic change of immune cells and cytokines throughout the first 4 weeks of the COVID-19 infection.Measure: To create an immune profile for each COVID19-positive patient during their ICU stay Time: 8 to 12 months
Description: A correlative analysis of the immune cells and cytokines levels with the COVID-19 severity and with the patient's outcome following their stay at the ICU. An attempt to identify markers associated with the disease severity and predictive measures to the patient's outcome.Measure: To correlate patients' immune profile to disease severity and patient's outcome Time: 4 to 6 months
This is a multi-center study comparing clinical outcomes in patients with COVID-19 in subjects hospitalized at Hadassah and other hospitals for PCR or serology confirmed COVID-19 and compare the outcomes to the presence of different degrees of a cytokine storm. The patients will be subdivided into a mild, moderate, and severe course according to NEWS2.
Description: To compare the clinical outcomes of patients with COVID-19 to Sepsis and CAR-T-related cytokine storm. This will be done by assessment of acute-illness severity using the NEWS2 scoring system (Higher scores mean more severe illness)Measure: Clinical Outcomes of Patients with COVID-19 using the National Early Warning Score 2 (NEWS2) system Time: 6 months
Description: To compare the clinical outcomes of patients with COVID-19 to Sepsis and CAR-T-related cytokine storm. This will be done by assessment of acute-illness severity using the new NIH Patient Classification to (1) Asymptomatic or Pre-symptomatic Infection; (2) Mild Illness; (3) Moderate Illness; (4) Severe Illness; (5) Critical Illness As detailed in the Study design section.Measure: Clinical Outcomes of Patients with COVID-19 using the new NIH Patient Classification of severity of illness Time: 6 months
Description: Incidence rate of Mortality from any causeMeasure: Mortality Time: 6 months
Description: To assess cytokine/chemokine/hematopoietic growth factors/ Complement and other immune modulators in patients with COVID-19 by measuring the serum concentrations of these factors in COVID-19 patients and compare those the levels of patients with sepsis and CAR T cytokine release syndrome.Measure: Cytokine/Chemokine/Hematopoietic Growth Factors/ Complement and Other Immune Modulators in Patients with COVID-19 Time: 6 months
The current Coronavirus Disease 2019 (COVID-19) pandemic has resulted in extraordinary public health orders of social distancing and self-isolation, leading to widespread disruption and discontinuation of cardiac rehabilitation programmes and other social opportunities for cardiovascular disease (CVD) patients to exercise. In Austria, the government initiated drastic public health measures on March 10, 2020, closing all outpatient cardiac rehabilitation facilities and restricting inpatient rehabilitation to patients with urgent medical indications only. This study aims to explore the impact of COVID-19-related national lockdown and public health restrictions on cardiac rehabilitation patients, with respect to maintenance of physical activity for secondary CVD prevention. The study poses three research questions, which will be addressed in a mixed-methods study with sequential quantitative-qualitative (QUANT-QUAL) design: 1. What was the impact of the COVID-19-related lockdown on patients' physical activity and physical fitness levels? (QUANT stage) 2. What was the patient experience of the closure of group-based cardiac rehabilitation training due to COVID-19 public health restrictions? (QUAL stage) 3. Which insights and learning points may be drawn from patients' experiences during COVID-19 public health restrictions with respect to the provision of home-based digital support for physical activity? (QUAL stage) The study will recruit a cohort of up to 40 cardiac rehabilitation patients from one outpatient cardiac rehabilitation centre in Salzburg, Austria, whose rehabilitation programme was interrupted by COVID-19 public health orders, including "lockdown". Patients will undergo re-assessment of physical fitness in cycle ergometry test and re-assessment of cardiovascular risk profile. This will be compared with patients' most recent available test results from before the COVID-19 lockdown (i.e. prior to mid-March 2020) from patient records. Additionally, patients will take part in a semi-structured qualitative interview in which they will be invited to reflect on their personal experiences during the COVID-19 lockdown and thereafter.
Description: Maximal work load (W) achieved in cycle ergometry testMeasure: Work load (W) Time: up to 12 months
Description: Maximal work load (W) achieved in cycle ergometry test expressed as percentage of predicted valueMeasure: Work load % of predicted value Time: up to 12 months
Description: Maximal heart rate (bpm) during cycle ergometry testMeasure: Heart rate (bpm) Time: up to 12 months
Description: Range 1% to 29%, higher percentage indicating worse risk estimateMeasure: Framingham Recurrent Coronary Heart Disease risk score Time: up to 12 months
Description: MET-minutes/week calculated from patient self-report of physical activity (International Physical Activity Questionnaire, IPAQ, 7 day version)Measure: Metabolic Equivalent (MET) minutes / week Time: up to 12 months
Description: Semi-structured qualitative interviewMeasure: Patient Experience Time: 5 months