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Navigate: Clinical Trials and HPO
Name (Synonyms) | Correlation | |
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drug4013 | power breathe Wiki | 0.20 |
drug2830 | Remdesivir-HU Wiki | 0.20 |
drug2189 | Nintedanib Wiki | 0.20 |
Name (Synonyms) | Correlation | |
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drug2496 | Placebo (PB0) Wiki | 0.20 |
drug31 | 1: Usual practice Wiki | 0.20 |
drug1761 | Janus Kinase Inhibitor (ruxolitinib) Wiki | 0.20 |
drug1908 | LungFit™ Wiki | 0.20 |
drug60 | 80 ppm Nitric Oxide delivered through LungFit Delivery System Wiki | 0.20 |
drug1615 | IgM and IgG antibodies assay Wiki | 0.20 |
drug2395 | PT-Pal Wiki | 0.20 |
drug517 | Breath test Wiki | 0.20 |
drug535 | Bronchoalveolar Lavage (BAL) Wiki | 0.20 |
drug679 | CYNK-001 Wiki | 0.20 |
drug45 | 2: Usual practice + SYMBICORT RAPIHALER Wiki | 0.20 |
drug3532 | Ulinastatin Wiki | 0.20 |
drug2849 | Respiratory and psychological rehabilitation Wiki | 0.20 |
drug1156 | Electrical Impedance Tomography (EIT) Wiki | 0.20 |
drug1658 | Inhaled Hypertonic ibuprofen Wiki | 0.20 |
drug1863 | Losmapimod oral tablet Wiki | 0.20 |
drug1667 | Inspiratory training device Wiki | 0.20 |
drug1829 | Linagliptin 5 MG Wiki | 0.20 |
drug26 | 150 ppm Nitric Oxide delivered through LungFit Delivery System Wiki | 0.20 |
drug228 | Angiotensin Receptor Blockers Wiki | 0.20 |
drug2540 | Placebo for Camostat Mesilate Wiki | 0.20 |
drug1789 | LYT-100 Wiki | 0.20 |
drug950 | Cross-sectional survey Wiki | 0.20 |
drug1305 | Fiberoptic Bronchoscopy (FOB) Wiki | 0.20 |
drug3232 | Stem Cell Product Wiki | 0.20 |
drug975 | DWJ1248 Wiki | 0.20 |
drug1257 | Extended sampling and procedures Wiki | 0.20 |
drug3037 | Self-guided exercises Wiki | 0.20 |
drug282 | Arterial Blood Gas test (ABG) Wiki | 0.20 |
drug2201 | Nitric Oxide delivered via LungFit™ system Wiki | 0.20 |
drug1247 | Expiratory training device Wiki | 0.20 |
drug2693 | Pulmonary Rehabilitation Wiki | 0.14 |
drug899 | Convalescent plasma Wiki | 0.13 |
drug3958 | no intervention Wiki | 0.12 |
drug2025 | Methotrexate Wiki | 0.11 |
drug3196 | Standard of Care (SoC) Wiki | 0.11 |
drug1116 | EIDD-2801 Wiki | 0.11 |
drug4099 | survey Wiki | 0.07 |
drug686 | Camostat Mesilate Wiki | 0.06 |
drug1023 | Dexamethasone Wiki | 0.06 |
drug2490 | Placebo Wiki | 0.05 |
drug2192 | Nitazoxanide Wiki | 0.05 |
drug1292 | Favipiravir Wiki | 0.04 |
drug2557 | Placebo oral tablet Wiki | 0.03 |
drug3430 | Tocilizumab Wiki | 0.03 |
drug1507 | Hydroxychloroquine Wiki | 0.02 |
Name (Synonyms) | Correlation | |
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D012120 | Respiration Disorders NIH | 0.88 |
D030341 | Nidovirales Infections NIH | 0.28 |
D012327 | RNA Virus Infections NIH | 0.21 |
Name (Synonyms) | Correlation | |
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D056152 | Respirat NIH | 0.20 |
D003333 | Coronaviridae Infections NIH | 0.18 |
D004700 | Endocrine System Diseases NIH | 0.14 |
D044882 | Glucose Metabolism Disorders NIH | 0.14 |
D012141 | Respiratory Tract Infections NIH | 0.13 |
D008659 | Metabolic Diseases NIH | 0.11 |
D053120 | Respiratory Aspiration NIH | 0.11 |
D007154 | Immune System Diseases NIH | 0.09 |
D011024 | Pneumonia, Viral NIH | 0.09 |
D003141 | Communicable Diseases NIH | 0.08 |
D045169 | Severe Acute Respiratory Syndrome NIH | 0.08 |
D008171 | Lung Diseases, NIH | 0.08 |
D018352 | Coronavirus Infections NIH | 0.07 |
D014777 | Virus Diseases NIH | 0.06 |
D005355 | Fibrosis NIH | 0.06 |
D003924 | Diabetes Mellitus, Type 2 NIH | 0.06 |
D007239 | Infection NIH | 0.05 |
D017563 | Lung Diseases, Interstitial NIH | 0.05 |
D011014 | Pneumonia NIH | 0.05 |
D011658 | Pulmonary Fibrosis NIH | 0.05 |
D001523 | Mental Disorders NIH | 0.04 |
D003920 | Diabetes Mellitus, NIH | 0.04 |
D013577 | Syndrome NIH | 0.02 |
Name (Synonyms) | Correlation | |
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HP:0000818 | Abnormality of the endocrine system HPO | 0.14 |
HP:0011947 | Respiratory tract infection HPO | 0.13 |
HP:0002088 | Abnormal lung morphology HPO | 0.09 |
Name (Synonyms) | Correlation | |
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HP:0005978 | Type II diabetes mellitus HPO | 0.06 |
HP:0006515 | Interstitial pneumonitis HPO | 0.05 |
HP:0002090 | Pneumonia HPO | 0.05 |
HP:0002206 | Pulmonary fibrosis HPO | 0.05 |
HP:0000819 | Diabetes mellitus HPO | 0.04 |
Navigate: Correlations HPO
There are 26 clinical trials
A randomized controlled clinical trial will be carried out using inspiratory and expiratory training devices on healthy subjects recruited in social networks and university environments. The aim will be to determine the effectiveness and safety in the prevention and severity of COVID-19 disease by a respiratory training with inspiratory and expiratory devices.
Description: Dichotomous categorical variable measured by "yes" or "no" responses
Measure: COVID-19 disease diagnosis Time: Change from Baseline COVID-19 disease diagnosis at 8 weeksDescription: Dichotomous categorical variable measured by "slight" or "severe" responses
Measure: COVID-19 disease symptoms severity Time: Change from Baseline COVID-19 disease symptoms severity at 8 weeksDescription: Polytomous categorical variable measured by adverse effects responses
Measure: Adverse effects Time: Change from Baseline adverse effects at 8 weeksOn Dec 31, 2019, a number of viral pneumonia cases were reported in China. The virus causing pneumonia was then identified as a new coronavirus called SARS-CoV-2. Since this time, the infection called coronavirus disease 2019 (COVID-19) has spread around the world, causing huge stress for health care systems. To diagnose this infection, throat and nose swabs are taken. Unfortunately, the results often take more than 24 hrs to return from a laboratory. Speeding diagnosis up would be of great help. This study aims to look at the breath to find signs that might allow clinicians to diagnose the coronavirus infection at the bedside, without needing to send samples to the laboratory. To do this, the team will be using a machine called a BreathSpec which has been adapted to fit in the hospital for this purpose.
Description: breath sample collection
Measure: To perform a study in patients with clinical features of pneumonia/chest infection to identify a signature of Covid-19 pneumonia in patients exposed to SARS-CoV-2, compared to unexposed patients or those without. Time: up to daily during hospital admissionDescription: breath sample collection
Measure: Detection of markers of Covid-19 pneumonia in non-invasive breath samples. Time: multiple samples up to 60 daysDescription: breath sample collection
Measure: Relationship of this biomarker signature to the presence of SARS-CoV-2 in nasal and throat swabs. Time: multiple samples up to 60 daysDescription: breath sample collection
Measure: Subsequently, the signature's relationship to other biomarkers of SARS-CoV-2 infection which are currently being explored Time: multiple samples up to 60 daysDescription: breath sample collection
Measure: In a smaller group of participants, ideally daily non-invasive breath samples will be collected to determine if there are changes between SARS-CoV-2 positive patients and those that are negative until hospital discharge or undue participant burden . Time: multiple samples up to 60 daysWe hypothesize that inhaled steroid therapy and long acting beta 2 adrenergic agonist, widely prescribed in asthma patients, may also have a local protective effect against coronavirus infection, even in patients without asthma. The primary purpose is To compare time to clinical improvement in patients receiving standard of care associated to the combination budesonide/formoterol or standard of care only. Time (in days) to clinical improvement is defined as the time from randomization to an improvement of two points (from the status at randomization) on a seven-category ordinal scale or live discharge from the hospital, whichever came first within 30 days.
Description: Time (in days) to clinical improvement is defined as the time from randomization to an improvement of two points (from the status at randomization) on a seven-category ordinal scale or live discharge from the hospital, whichever came first within 30 days. The seven-category ordinal scale consisted of the following categories: Not hospitalized with resumption of normal activities Not hospitalized, but unable to resume normal activities Hospitalized, not requiring supplemental oxygen Hospitalized, requiring supplemental oxygen Hospitalized, requiring nasal high-flow oxygen therapy, non-invasive mechanical ventilation, or both; Hospitalized, requiring ECMO, invasive mechanical ventilation, or both Death. These parameters will be evaluated daily during hospitalization.
Measure: Time (in days) to clinical improvement within 30 days after randomization Time: within 30 daysProspective cohort study of COVID-19 infection among children in Norway.
Description: Identify comorbidities predisposing for severe infection
Measure: Risk Factors for severe infection Time: 2030Description: Immunological response to acute infection, focusing on initial innate host response and its associations to inflammatory enhancement, genetic factors and clinical course.
Measure: Immunulogical mechanisms Time: 2030Description: prevalence and risk factors of long-lasting complication, in particular the development of post-infectious chronic fatigue
Measure: Long term outcome Time: 2030The emerging field of stem cell therapy holds promise of treating a variety of diseases. Especially the mesenchymal stromal cells from bone marrow or adipose tissue (ASCs) have proven their potential for regenerative therapy in patients with ischemic heart disease. Both of these cell types have putative immunomodulatory properties, as they have demonstrated their ability to evade recognition and actively suppress the immune system. This knowledge is transferred into studies with COVID-19 patients having severe pulmonary dysfunction, to modify the virus induced immunological and inflammatory activity involved in the progression of disease often leading to prolonged ICU stay and in some occasion's death. We will conduct a clinical trial in which patients with COVID-19 and severe pulmonary symptoms will be randomized to either placebo or treatment with allogeneic CSCC_ASCs from adipose tissue. The aim is to assess the impact of CSCC_ASCs on the activated immune system and clinical efficacy on pulmonary function. The perspective is that this new information can be of pivotal importance and potentially be a paradigm shift for the clinical problems and severe outcome seen in some patients with severe COVID-19 and other severe diseases with Acute Respiratory Distress Syndrome.
This study is a Phase 1 / 2 trial to determine the safety and efficacy of CYNK-001, an immunotherapy containing Natural Killer (NK) cells derived from human placental CD34+ cells and culture-expanded, in patients with moderate COVID-19 disease.
Description: Number and severity of adverse events
Measure: Phase 1: Frequency and Severity of Adverse Events (AE) Time: Up to 6 monthsDescription: Proportion of subjects with "negative" measurement of COVID-19 by rRT-PCR
Measure: Phase 1: Rate of clearance of SARS-CoV-2 Time: Up to 6 monthsDescription: Proportion of subjects who improved clinical symptoms related to lower respiratory tract infection, as measured by National Early Warning Score 2 (NEWS2) score.
Measure: Phase 1: Rate of clinical improvement Time: Up to 6 monthsDescription: Time from the date of randomization to the clearance of SARS-CoV-2 by rRT-PCR. Negative results will need to be confirmed by a second negative result in the same sample type at least 24 hours after the first negative result.
Measure: Phase 2: Time to Clearance of SARS-CoV-2 Time: Up to 28 daysDescription: Time from the date of randomization to the first date of improved clinical symptoms related to lower respiratory tract infection. Improvement as measured by National Early Warning Score 2 (NEWS2) Score.
Measure: Phase 2: Time to Clinical Improvement by NEWS2 Score Time: Up to 28 daysDescription: Proportion of subjects with "negative" measurement of COVID-19 by rRT-PCR
Measure: Rate of Clearance of SARS-CoV-2 Time: Up to 6 monthsDescription: Number and severity of adverse events
Measure: Phase 2: Frequency and Severity of Adverse Events (AE) Time: up to 6 monthsDescription: Time to medical discharge as an assessment of overall clinical benefit
Measure: Overall Clinical Benefit by time to medical discharge Time: up to 6 monthsDescription: Hospital utilization will be measured as an assessment of overall clinical benefit
Measure: Overall Clinical Benefit by hospital utilization Time: up to 6 monthsDescription: Mortality rate will be measured as an assessment of overall clinical benefit
Measure: Overall Clinical Benefit by measuring mortality rate Time: up to 6 monthsDescription: Assess the impact of CYNK-001 on changes in sequential organ failure assessment (SOFA) score.
Measure: Impact of CYNK-001 on sequential organ failure assessment (SOFA) score Time: Up to 28 daysDescription: Time from randomization to the date of disappearance of virus from lower respiratory tract infection (LRTI) specimen where it has previously been found (induced sputum, endotracheal aspirate).
Measure: Time to Pulmonary Clearance Time: Up to 28 daysDescription: For ventilatory support subjects, the days with supplemental oxygen-free.
Measure: Supplemental oxygen-free days Time: Up to 28 daysDescription: Proportion of subjects who need invasive or non-invasive ventilation
Measure: Proportion of subjects requiring ventilation Time: Up to 28 daysThe SARS-CoV2 virus causes severe or even fatal disease in a fraction of infected people. The clinical severity is based on a complicated pneumopathy with acute respiratory distress syndrome that can lead to multi-visceral failure. The underlying mechanism is a cytokinergic storm, an emerging facet of immunological dysregulation. This clinical trial is aimed to understand the mechanisms of this immunological dysregulation in order to identify therapeutic levers. The main objective is to understand the relationships between clinical severity, death or morbidity of resuscitation management, and immune status (i.e., immune pathways activated or not). Immune status will be investigated at many levels of organization (i.e., circulating leukocytes, cytokines and chemokines, transcripts). The secondary objectives are : - to understand what is responsible for clinical severity, viral load, or immune activation; - to highlight the consequences of immunological dysregulation on associated risks (i.e., immunosuppression leading to the emergence of infectious comorbidities) as well as the functioning of neurotransmission through metabolic pathway diversions. The impact of dysimmunity on these biological pathways will be assessed with a metabolomic analysis; - to understand the mechanisms of vulnerability related to the field. Moreover, while co-morbidities are likely to be a risk factor for severe disease progression, there are many situations in which they do not occur. Stress, with its neurovegetative and endocrinological dimensions, modulates the immune response. It is essential to know whether the stress response plays a role in immunological dysregulation. This analysis is a prerequisite for understanding the conditions of treatment with glucocorticoids. Angiotensin converting enzyme type 2 (ACE2) also plays a likely role in host viral infection. It is also thought to play an important role in the emergence of severe syndromes by affecting the quality of vascular response.
Description: Mortality
Measure: Mortality Time: 90 days following the enrollmentDescription: Th1/Th2/Th17/Treg balance, Type I Interferons and inflammation
Measure: Immune response - Plasma cytokine profile Time: Through study completion (90 days following the enrollment)Description: T cells (CD3, CD4, CD8, PD1, FAS, CD45RO, CTLA4+, CXCR5, CXCR3, CCR6, CD69, CD95, HLA-DR) and B cells (CD3, CD19, CD27, IgD, CD69) with cell subtypes and memory/naive compartments (CD27, CD38, IgD, IgG1, IgG2, IgG3, CD20, CD24), NK cells (CD14, CD16, CD56, HLA-DR), monocytes (CD14, CD45, HLA-DR, PDL-1)
Measure: Immune response - Phenotype of circulating cells Time: Through study completion (90 days following the enrollment)Description: Number of days in intensive care unit
Measure: Severity criteria - Duration of stay in intensive care unit Time: 90 days following the enrollmentDescription: Number of days of hospitalization
Measure: Severity criteria - Duration of hospitalization stay Time: 90 days following the enrollmentDescription: Number of days out of hospital
Measure: Severity criteria - Duration of period out of hospital Time: 90 days following the enrollmentDescription: Number of days without mechanical ventilation (invasive/non-invasive)
Measure: Severity criteria - Duration without mechanical ventilation Time: 90 days following the enrollmentDescription: Number of days not being ventilated
Measure: Severity criteria - Duration without ventilation Time: 90 days following the enrollmentDescription: Number of days not being intubated
Measure: Severity criteria - Duration without intubation Time: 90 days following the enrollmentDescription: Number of transfusions
Measure: Severity criteria - Number of transfusions Time: 90 days following the enrollmentDescription: Number of days without cathecholamines
Measure: Severity criteria - Duration of the period without cathecholamines Time: 90 days following the enrollmentDescription: Number of days without dialysis
Measure: Severity criteria - Duration of the period without dialysis Time: 90 days following the enrollmentDescription: Sepsis-related Organ Failure Assessment (SOFA) Score
Measure: Severity criteria - SOFA Time: Through study completion (90 days following the enrollment)Description: Lung Injury Score (LIS)
Measure: Severity criteria - LIS Time: Through study completion (90 days following the enrollment)Description: SARS-Cov2 viral load will be measured in blood and in broncho-tracheal secretions
Measure: SARS-Cov2 viral load Time: Through study completion (90 days following the enrollment)Description: Co-infections and acquired infections (bacterial or fungal) in intensive care unit, in particular based on an all-site positive PCR for EBV and/or CMV and/or HSV
Measure: Emergence of concomitant infections Time: 90 days following the enrollmentDescription: T cells (CD3, CD4, CD8, PD1, FAS, CD45RO, CTLA4+, CXCR5, CXCR3, CCR6, CD69, CD95, HLA-DR) and B cells (CD3, CD19, CD27, IgD, CD69) with cell subtypes and memory/naive compartments (CD27, CD38, IgD, IgG1, IgG2, IgG3, CD20, CD24), NK cells (CD14, CD16, CD56, HLA-DR), monocytes (CD14, CD45, HLA-DR, PDL-1)
Measure: Emergence of concomitant infections - Phenotype of circulating cells Time: Through study completion (90 days following the enrollment)Description: Heart rate variability
Measure: Stress physiological profile - Sympathetic tone Time: Through study completion (90 days following the enrollment)Description: Core temperature
Measure: Stress physiological profile - Temperature Time: Through study completion (90 days following the enrollment)Description: Quantity of glucocorticoids in the urine during 24 hours and at night
Measure: Stress physiological profile - Glucocorticoids Time: Through study completion (90 days following the enrollment)Description: ACE Polymorphism
Measure: Angiotensin converting enzyme type II (ACE2) polymorphism - ACE Time: At enrollmentDescription: Protein expression of ACE2 vs. ACE1 and angiotensin II chain proteins
Measure: Angiotensin converting enzyme type II (ACE2) polymorphism - ACE2/ACE1 Time: At enrollmentDescription: Diabete diagnosis
Measure: Comorbidities - diabetes Time: At enrollmentDescription: Heart disease diagnosis
Measure: Comorbidities - Heart disease Time: At enrollmentDescription: Organ failure diagnosis
Measure: Comorbidities - organ failure Time: At enrollmentDescription: GABA level in blood and urine
Measure: Plasma concentrations of several metabolic pathways - GABA Time: Through study completion (90 days following the enrollment)Description: Glucocorticoid level in blood and urine
Measure: Plasma concentrations of several metabolic pathways - Glucocorticoid Time: Through study completion (90 days following the enrollment)Description: Tryptophan in blood and urine
Measure: Plasma concentrations of several metabolic pathways - Tryptophan Time: Through study completion (90 days following the enrollment)Description: Serotonin level in blood and urine
Measure: Plasma concentrations of several metabolic pathways - Serotonin Time: Through study completion (90 days following the enrollment)Description: Dopamin level in blood and urine
Measure: Plasma concentrations of several metabolic pathways - Dopamin Time: Through study completion (90 days following the enrollment)Description: Catecholamines level in blood and urine
Measure: Plasma concentrations of several metabolic pathways - Cathecholamines Time: Through study completion (90 days following the enrollment)Description: Arachidonic acid derivatives level in blood and urine
Measure: Plasma concentrations of several metabolic pathways - Arachidonic acid derivatives Time: Through study completion (90 days following the enrollment)Description: Endocannabinoids level in blood and urine
Measure: Plasma concentrations of several metabolic pathways - Endocannabinoids Time: Through study completion (90 days following the enrollment)The coronavirus disease 2019 (COVID-19) is an emerging pandemic in 2020 caused by a novel coronavirus named SARS-CoV2. Diabetes confers a significant additional risk for COVID-19 patients. Dipeptidyl peptidase 4 (DPP-4) is a transmembrane glycoprotein expressed ubiquitously in many tissues. In addition to its effect on glucose levels, DPP-4 has various effects on the immune system and several diseases, including lung diseases. This trial aims to assess the safety and efficacy of linagliptin, a DPP-4 inhibitor, in the treatment of COVID-19. The trial will be randomized without blinding, with one are treated by insulin only for glucose balance and the other by insulin and linagliptin. The trial will assess the effects of linagliptin on different measures of COVID-19 recovery.
Description: Clinical change is defined as 2 points reduction in the World Health Organization (WHO) Ordinal Scale for Clinical Improvement of COVID-19: 0 - No clinical or virological evidence of infection; 1 - No limitation of activities; 2 - Limitation of activities; 3 - Hospitalized, no oxygen therapy; 4 - Oxygen by mask or nasal prongs; 5 - Non-invasive ventilation or high-flow oxygen; 6 - Intubation and mechanical ventilation; 7 - Ventilation + additional organ support - pressors, renal replacement therapy, extracorporeal membrane oxygenation; 8 - Death.
Measure: Time to clinical change Time: 28 daysDescription: Percent of patients with a 2 points reduction in the World Health Organization (WHO) Ordinal Scale for Clinical Improvement of COVID-19.
Measure: Percent of patients with clinical improvement. Time: 28 daysThe study aims to evaluate the reduction in severity and progression of lung injury with inhaled ibuprofen in patients with severe acute respiratory syndrome due to SARS-CoV-2 virus.
Description: Time to clinical improvement: defined as time from inhaled Ibuprofen first dose to an improvement of three points from the status on a seven-category ordinary scale
Measure: Change in the scale of ordinary COVID results at 7, 14 and 28 days in patients with acute respiratory infection, induced by SARS-CoV-2, treated with inhaled Ibuprofen. Time: 7, 14 and 28 daysDescription: Negativization of two consecutive pharyngo-nasal swab 24-72 hrs apart
Measure: Change to Negativization of the swab to the following treatment points on day 7, day 14, 21 and 28 after treatment with inhaled Ibuprofen. Time: 7, 14 and 28 daysDescription: NEWS2 score 20 points is the maximum and indicates that the patient needs emergent assessment by a clinical team or critical care team and usually transfer to higher level of care.
Measure: Average score of National Early Warning (NEWS2) between days 1, 7, 14 and 28. Time: 1, 7, 14 and 28Description: qSOFA, score for sepsis, a maximum value of 3 indicates high risk qSOFA Scores 2-3 are associated with a 3- to 14-fold increase in in-hospital mortality. Assess for evidence of organ dysfunction with blood testing including serum lactate and calculation of the full SOFA Score. Patients meeting these qSOFA criteria should have infection considered even if it was previously not.
Measure: Average change in quick sepsis-related organ failure assessment score (qSOFA) score between day 1, 7, 14 and 28. Time: 1, 7, 14 and 28 daysThis study applied the Pulmonary Rehabilitation Adapted Index of Self-Efficacy (PRAISE) on respiratory patients who had their on-going ambulatory Pulmonary Rehabilitation program interrupted due to the COVID-19 outbreak. The research hypothesis is that ranking patients' self-efficacy is a useful screening tool to support patients' follow-up on a Pulmonary Rehabilitation telehealth solution to be explored during the COVID-19 outbreak.
Description: Vincent and co-authors (2011) proposed the Pulmonary Rehabilitation Adapted Index of Self-Efficacy (PRAISE). The PRAISE tool is composed by a total of 15 items, combining 10 items from the General Self-Efficacy Scale (GSE) by Schwarzer and Jerusalem (1995), and 5 new specific items related to Pulmonary Rehabilitation. Each item is scored from 1 to 4 with a total range from 15 to 60, with higher scores indicating higher levels of self-efficacy. This study applies the Portuguese PRAISE version by Santos CD and co-authors (2019).
Measure: Patient's self-efficacy Time: 3 daysDescription: Patients were questioned if they were engaging on a daily routine of respiratory exercises by their initiative while isolated at home COVID-19 outbreak. The answer was registered as yes/no.
Measure: Respiratory exercises Time: 3 daysDescription: Patients were questioned if they managed to preserve a daily period to practice physical activity while isolated at home during COVID-19 outbreak. The answer was recorded as yes/no. In case of a positive answer, information concerning available equipment and exercise protocol adopted at patient's home environment was also collected.
Measure: Physical activity Time: 3 daysDescription: Number of Pulmonary Rehabilitation hospital sessions completed as outpatient, according to Hospital Pulido Valente information system
Measure: Treatment sessions completed Time: 3 daysDescription: Number of Pulmonary Rehabilitation sessions planned per week, according to Hospital Pulido Valente information system
Measure: Treatment weekly frequency Time: 3 daysThe Controlled evaLuation of Angiotensin Receptor Blockers for COVID-19 respIraTorY disease (CLARITY) study is a pragmatic prospective, open-label, randomised controlled trial. CLARITY aims to examine the effectiveness of angiotensin II receptor blockers (ARBs) on improving the outcomes of people who tested positive for COVID-19 disease.
Description: To determine whether the addition of the intervention, compared to standard care, changes the clinical health score of a participant on the following scale; Not hospitalized, no limitations on activities. Not hospitalized, limitation on activities; Hospitalized, not requiring supplemental oxygen; Hospitalized, requiring supplemental oxygen; Hospitalized, on non-invasive ventilation or high flow oxygen devices; Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); Death;
Measure: 7-Point National Institute of Health Clinical Health Score Time: 14 DaysDescription: To determine whether the addition of the intervention, compared to standard care, changes the clinical health score of a participant on the following scale; Not hospitalized, no limitations on activities. Not hospitalized, limitation on activities; Hospitalized, not requiring supplemental oxygen; Hospitalized, requiring supplemental oxygen; Hospitalized, on non-invasive ventilation or high flow oxygen devices; Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); Death;
Measure: 7-Point National Institute of Health Clinical Health Score Time: 28 DaysDescription: To determine whether the addition of the intervention, compared to standard care, changes the risk of all cause mortality
Measure: Mortality Time: 28 DaysDescription: To determine whether the addition of the intervention, compared to standard care, changes the risk of all cause mortality
Measure: Mortality Time: 90 DaysDescription: To determine whether the addition of the intervention, compared to standard care, changes the count of all cause Intensive Care Unit admission
Measure: Intensive Care Unit Admission Time: 28 DaysDescription: To determine whether the addition of the intervention, compared to standard care, changes the count of all cause Intensive Care Unit admission
Measure: Intensive Care Unit Admission Time: 90 DaysDescription: To determine whether the addition of the intervention, compared to standard care, changes the number of days total, of intensive care unit admission
Measure: Intensive Care Unit Number of Days Time: 90 DaysDescription: To determine whether the addition of the intervention, compared to standard care, changes the incidence of respiratory failure
Measure: Respiratory Failure Time: 28 DaysDescription: To determine whether the addition of the intervention, compared to standard care, changes the requirements for dialysis
Measure: Dialysis Requirement Time: 28 DaysDescription: To determine whether the addition of the intervention, compared to standard care, changes the number of hospitalisation days
Measure: Hospitalisation Days Time: 28 DaysDescription: To determine whether the addition of the intervention, compared to standard care, changes the number of hospitalisation days
Measure: Hospitalisation Days Time: 90 DaysDescription: To determine whether the addition of the intervention, compared to standard care, changes need for ventilation
Measure: Ventilator-Free Days Time: 28 DaysDescription: To determine whether the addition of the intervention, compared to standard care, changes need for dialysis
Measure: Dialysis Days Time: 28 DaysDescription: To determine whether the addition of the intervention, compared to standard care, changes risk of acute kidney injury, based on the idney Disease: Improving Global Outcomes definition
Measure: Acute Kidney Injury Time: 28 DaysDescription: To determine whether the addition of the intervention, compared to standard care, changes risk of hypotension requiring vasopressors
Measure: Hypotension Requiring Vasopressors Time: 28 DaysDescription: To determine whether the addition of the intervention, compared to standard care, changes risk of hyperkalaemia.
Measure: Hyperkalaemia Time: Day 28Description: To determine whether the addition of the intervention, compared to standard care, changes risk of decreased oxygen saturation
Measure: Oxygen Saturation Time: Day 28Description: To determine whether the addition of the intervention, compared to standard care, changes risk of decreased oxygen saturation
Measure: Oxygen Saturation Time: Day 14The purpose of this open label, randomized, study is to obtain information on the safety and efficacy of 80 ppm Nitric Oxide given in addition to the standard of care of patients with COVID-19 caused by SARS-CoV-2.
Description: Time to deterioration measured by need for NIV, HFNC or intubation
Measure: Time to deterioration Time: 14 DaysDescription: Time to non-invasive ventilation
Measure: Time to NIV Time: 14 DaysDescription: Time to high flow nasal cannula
Measure: Time to HFNC Time: 14 DaysDescription: Time to intubation
Measure: Time to intubation Time: 14 daysDescription: Time to patient having stable oxygen saturation (SpO2) of greater than or equal to 93%
Measure: Time to patient having stable oxygen saturation (SpO2) of greater than or equal to 93% Time: 14 daysDescription: Need for supplemental oxygen
Measure: Need for supplemental oxygen Time: 14 daysDescription: Change in viral load
Measure: Change in viral load Time: 30 daysDescription: Duration of the Hospital Length of Stay (LOS)
Measure: Duration of the Hospital Length of Stay (LOS) Time: 14 daysDescription: Mortality rate at Day 30
Measure: Mortality rate at Day 30 Time: 30 daysA new Coronavirus (SARS-CoV-2) emerged in Wuhan Province, China in December 2019 and rapidly spread around the world. To date, the data in the literature regarding the clinical and epidemiological characteristics of severe forms of CoVid-19 in patients with chronic respiratory disease are not well known. The hypothesis is that patients with chronic respiratory disease (COPD, asthma, bronchial dilatations, pulmonary hypertension, cystic fibrosis, obesity-hypoventilation syndrome, obstructive sleep apnea syndrome) infected with SARS-Cov-2 will have increased dyspnea and hypoxemia leading to hospitalization for severe forms more frequently than the general population. However, they do not appear to be more at risk of developing a critical form. This study is carried out in order to propose to estimate the prevalence of critical forms of CoVid19 among patients with chronic respiratory diseases hospitalized for severe forms.
Description: Value of 6 or greeter on WHO CoVid-19 scale, indicating of a critical form of CoVid-19.
Measure: Percentage of patients who reached, during their hospitalization, a value greater than or equal to 6 on the WHO CoVid-19 infection progression scale Time: up to 28 days (during hospitalisation)Description: Radiological damage (extension of ground-glass) could be a predictive factor.
Measure: Determined potential predictive factors of critic form in patients with chronic lung diseases Time: up to 28 days (during hospitalisation)Description: intra-hospital death, intra-ICU death
Measure: Determined percentage of death Time: up to 28 days (during hospitalisation)Description: in days (or duration at a different flow rate compared to long-term home oxygen therapy prior to hospitalization)
Measure: Determined duration of oxygen therapy Time: up to 28 days (during hospitalisation)Description: in days for patients with chronic respiratory disease between the date of admission and the date of discharge. Patients who died during hospitalization will be assigned the highest cohort value.
Measure: Determined duration of hospitalization Time: up to 28 days (during hospitalisation)Description: values will be measured at D3, D7 and D14 in each of the groups. Patients who do not reach D7 and D14 will have the last postponement
Measure: Determine mean values of the WHO CoVid-19 infection progression scale measured Time: up to 28 days (during hospitalisation)The purpose of this open label, 2-phase, study is to obtain information on the safety of 80 ppm and the safety and efficacy of 150 ppm Nitric Oxide given in addition to the standard of care of patients with COVID-19 caused by SARS-CoV-2.
Description: Time to deterioration as measured by any one of the following: need for non-invasive ventilation need for high flow nasal cannula (HFNC) or need for intubation Death from any cause
Measure: Time to deterioration Time: up to 14 daysDescription: Time to patient having stable oxygen saturation (SpO2) of greater than 92% for longer than 3 hr on room air
Measure: Time to stable oxygen saturation Time: up to 14 daysDescription: Treatment Emergent Adverse Events and SAEs - safety evaluation for 30 days after last inhalation treatment
Measure: Treatment Emergent Adverse Events and SAEs Time: 30 days after last inhalation treatmentThe overall objective of the study is to determine the therapeutic effect and tolerance of Tocilizumab combined with Dexamethasone in patients with moderate, severe pneumonia or critical pneumonia associated with Coronavirus disease 2019 (COVID-19). Tocilizumab (TCZ) is an anti-human IL-6 receptor monoclonal antibody that inhibits signal transduction by binding sIL-6R and mIL-6R. The study has a cohort multiple Randomized Controlled Trials (cmRCT) design. Randomization will occur prior to offering Dexamethasone alone or Dexamethasone +Tocilizumab administration to patients enrolled in the CORIMUNO-19 cohort. Tocilizumab will be administered to consenting adult patients hospitalized with COVID-19 either diagnosed with moderate or severe pneumonia requiring no mechanical ventilation or critical pneumonia requiring mechanical ventilation. Patients who will chose not to receive Tocilizumab will receive standard of cares. Outcomes of Tocilizumab-treated patients will be compared with outcomes of standard of care (including Dexamethasone) treated patients
Description: Survival without needs of ventilator utilization (including non invasive ventilation and high flow) at day 14. Thus, events considered are needing ventilator utilization (including Non Invasive Ventilation, NIV or high flow), or death.
Measure: Survival without needs of ventilator utilization at day 14 Time: day 14Description: WHO progression scale: Uninfected; non viral RNA detected: 0 Asymptomatic; viral RNA detected: 1 Symptomatic; Independent: 2 Symptomatic; Assistance needed: 3 Hospitalized; No oxygen therapy: 4 Hospitalized; oxygen by mask or nasal prongs: 5 Hospitalized; oxygen by NIV or High flow: 6 Intubation and Mechanical ventilation, pO2/FIO2>=150 OR SpO2/FIO2>=200: 7 Mechanical ventilation, (pO2/FIO2<150 OR SpO2/FIO2<200) OR vasopressors (norepinephrine >0.3 microg/kg/min): 8 Mechanical ventilation, pO2/FIO2<150 AND vasopressors (norepinephrine >0.3 microg/kg/min), OR Dialysis OR ECMO: 9 Dead: 10
Measure: WHO progression scale at day 7 and 14 Time: day 7 and day 14Description: Overall survival
Measure: Overall survival at 14, 28, 60 and 90 days Time: 14, 28, 60 and 90 daysDescription: Cumulative incidence of discharge alive
Measure: Cumulative incidence of discharge alive at 14 and 28 days Time: 14 and 28 daysDescription: Survival without needs of mechanical ventilation at day 1. New DNR order (if given after the inclusion of the patient) will be considered as an event at the date of the DNR.
Measure: Survival without needs of mechanical ventilation at day 1 Time: day 1Description: Cumulative incidence of oxygen supply independency
Measure: Cumulative incidence of oxygen supply independency at 14 and 28 days Time: 14 and 28 daysThe COVID-19 pandemic has had a dramatic effect in public health worldwide. In Brazil, there have been more than 2 million confirmed cases and over 75,000 deaths since February 26, 2020. Based on reports of a hyperinflammatory state associated with COVID-19, the use of immunosuppressive drugs may be efficacious in the treatment of this disease. JAK inhibitors have been shown to harness inflammation in a number of different pathologic conditions. The aim of the present study is to evaluate the efficacy and safety of JAK inhibitor ruxolitinib in patients with acute respiratory distress syndrome due to COVID-19.
Description: ICU admission, mechanical ventilation, death or consent withdrawal
Measure: Time to treatment failure Time: 28 daysFiberoptic bronchoscopy (FOB) is widely used as a diagnostic or therapeutic procedure in intensive care units. Patients with ARDS or COVID-19 disease often undergoes to these procedures. However, intensive care patients might suffer from serious side effects such as prolonged oxygen desaturation and adverse change in lung compliance and resistance. This study aims to evaluate these changes and determine their impact on patient stability.
Description: The variation of regional compliance, calculated by electrical impedance
Measure: Regional Compliance Variation Time: From FOB/BAL to 6 hours laterDescription: The variation of regional resistance, calculated by electrical impedance
Measure: Regional Resistance Variation Time: From FOB/BAL to 6 hours laterDescription: Relation between regional compliance variation and FOB duration
Measure: Regional Compliance and FOB duration Time: From FOB/BAL to 6 hours laterDescription: Relation between regional compliance variation and PaO2 variation
Measure: Regional Compliance and PaO2 Time: From FOB/BAL to 6 hours laterDescription: Relation between atelectasis impedance-detected areas and BAL flooded impedance-detected areas
Measure: Atelectasis areas and BAL flooded areas Time: From FOB/BAL to 6 hours laterDescription: Variation of PaO2 and PaO2/FiO2 ratio post FOB/BAL
Measure: PaO2 and PaO2/FiO2 ratio Time: From FOB/BAL to 6 hours laterDescription: Variation of PaCO2 post FOB/BAL
Measure: PaCO2 Time: From FOB/BAL to 6 hours laterDescription: Relation between the endotracheal tube/fiberscope size ratio and gas exchanges
Measure: Endotracheal tube size and Fiberscope size Time: From FOB/BAL to 6 hours laterDescription: Heart rate (HR), Blood Pressure (BP)
Measure: Hemodynamic variations Time: From FOB/BAL to 6 hours laterOne of the major problems in suppressing the spreading of an epidemic resides in understanding and monitoring its propagation patterns, and in evaluating how these are modified by enforced policies. The standard solution requires detailed information at the microscopic scales, e.g. how infected people have moved and whom they came in contact with, which is hardly ever available. The researchers propose a novel approach to the study of the propagation of COVID-19, in which a proxy of this information is derived at macroscopic scales. This will be based on two ingredients: the spatiotemporal study in shiny with mathematical models with aggregated or non aggregated data and the reconstruction of functional networks of spreading patterns, and the development of a supporting software.
Description: spatiotemporal spread of COVID-19 patient in our hospital
Measure: spatiotemporal spread Time: February 1, 2020 to September 30, 2020Description: risk classification score of each patients with clinical and analytical variables
Measure: classification score Time: February 1, 2020 to September 30, 2020COVID 19 has become a pandemic and has led to high demand on healthcare systems. It can cause a severe acute respiratory syndrome (SARS CoV-2) which leads to a long hospital stay, developing important functional damage and making hospital discharge difficult. Elderly, obese and people with chronic diseases are more susceptible to contracting the disease, this profile of patients already has a predisposition for respiratory muscle weakness and in this context, after clinical stability, it is still necessary in a hospital environment to approach respiratory and motor physiotherapy. to optimize the recovery of these patients. Objective: Improved breathing, functionality, exercise capacity and muscle strength in non-critical patients. Method: Prospective randomized clinical study where one group received motor and respiratory physiotherapy and the other group performed the same therapy associated with inspiratory muscle training. Results: The findings will be compared before and after the approach and will be presented in graphs and tables. Statistical tests will be used considering a significance level of 5%.
Description: respiratory muscle training appears to impact functionality
Measure: impact on functionality Time: 14 daysThe purpose of this multi center, open label, randomized, study is to obtain information on the safety and efficacy of 150 ppm Nitric Oxide given in addition to the standard of care of patients with viral pneumonia
Description: Clinical safety will be assessed by incidence of Serious Adverse Events (SAEs)
Measure: incidence of Serious Adverse Events Time: 30 daysDescription: Time to fever resolution
Measure: fever resolution Time: Baseline to 30 daysDescription: Number of patients requiring admission to ICU
Measure: ICU admission Time: Baseline to 30 daysDescription: Time until patient no longer requires supportive oxygen
Measure: Oxygen support Time: Baseline to 30 daysDescription: b.d. Stable room air saturation of 93% and above or returning to baseline saturation, whichever is lower
Measure: Stable room air saturation Time: Baseline to 30 daysThis is a collaborative study between Icahn School of Medicine at Mount Sinai and Boehringer Ingelheim Pharmaceuticals to determine the effect of Nintedanib on slowing the rate of lung fibrosis in patients who have been diagnosed with COVID-19, and have ongoing lung injury more than 4 weeks out from their diagnosis.
Description: Change in Forced Vital Capacity (FVC) at 180 days as compared to baseline. Forced vital capacity (FVC) is the amount of air that can be forcibly exhaled from your lungs after taking the deepest breath possible, as measured by spirometry.
Measure: Change in Forced Vital Capacity (FVC) Time: Baseline and 180 daysDescription: Death within 90 days and 180 days from enrollment due to a respiratory cause
Measure: Number of deaths due to respiratory cause Time: within 90-180 daysDescription: Quantitative Change in chest CT visual score graded by blinded chest radiologists. Data driven texture analysis (DTA) is a patented deep learning method to quantify lung fibrosis. DTA score is reported in percentage ranging from 0% to 100%. A minimally clinical important difference when comparing CT scans from the same subject is 4%. A higher percentage suggests worsening lung injury.
Measure: Chest CT visual score Time: 180 daysDescription: The Saint George's Respiratory Questionnaire (SGRQ) is a self-reported disease-specific, health-related quality of life (QOL) questionnaire. 50-item instrument. Scores range from 0 to 100, with higher scores indicating more limitations.
Measure: St. George's Respiratory Questionnaire (SGRQ) Time: Day 90Description: The Saint George's Respiratory Questionnaire (SGRQ) is a self-reported disease-specific, health-related quality of life (QOL) questionnaire. 50-item instrument. Scores range from 0 to 100, with higher scores indicating more limitations.
Measure: St. George's Respiratory Questionnaire (SGRQ) Time: Day 180Description: The King's Brief Interstitial Lung Disease (KBILD) questionnaire is a self-administered, ILD-specific measure of health-related quality of life, comprising 15 items with three domains (Psychological (KBILD-P), Breathlessness and activities (KBILD-B), and Chest symptoms (KBILD-C)) combined in a total score (KBILD-T). The KBILD domain and total score ranges are 0-100; 100 represents best health status.
Measure: King's Brief Interstitial Lung Disease (KBILD) Time: Day 90Description: The King's Brief Interstitial Lung Disease (KBILD) questionnaire is a self-administered, ILD-specific measure of health-related quality of life, comprising 15 items with three domains (Psychological (KBILD-P), Breathlessness and activities (KBILD-B), and Chest symptoms (KBILD-C)) combined in a total score (KBILD-T). The KBILD domain and total score ranges are 0-100; 100 represents best health status.
Measure: King's Brief ILD (KBILD) Time: Day 180Description: The LCQ is a 19 item questionnaire that assesses cough-related QOL. It has 3 domains (physical, psychological and social). The domain scores range from 1-7 and total score range is 3-21 with a higher score indicating a better quality of life.
Measure: Leicester Cough Questionnaire (LCQ) Time: Day 90Description: The LCQ is a 19 item questionnaire that assesses cough-related QOL. It has 3 domains (physical, psychological and social). The domain scores range from 1-7 and total score range is 3-21 with a higher score indicating a better quality of life.
Measure: Leicester Cough Questionnaire Time: Day 180Description: The (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 is a measure of health status. Scores range from 0 - 100, with higher scores indicating less disability.
Measure: Short Form (SF) 36 Health Survey Time: Day 90Description: The (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 is a measure of health status. Scores range from 0 - 100, with higher scores indicating less disability.
Measure: SF 36 Health Survey Time: Day 180Description: Questionnaire with 7 items for anxiety and 7 items for depression, each item is scored on a 4 point response 0 - 3, with full range from 0 to 42, with higher score indicating more severe anxiety or depression. 14-items scale with responses scored from 0-3, scores for each subscale from 0 (normal) to 21 (severe symptoms). Scores for the entire scale is 0 to 42, with higher score indicating more distress.
Measure: Hospital Anxiety and Depression Scale (HADS) Time: Day 90Description: Questionnaire with 7 items for anxiety and 7 items for depression, each item is scored on a 4 point response 0 - 3, with full range from 0 to 42, with higher score indicating more severe anxiety or depression. 14-items scale with responses scored from 0-3, scores for each subscale from 0 (normal) to 21 (severe symptoms). Scores for the entire scale is 0 to 42, with higher score indicating more distress.
Measure: Hospital Anxiety and Depression Scale (HADS) Time: Day 180Description: Number of participants with Increase in liver transaminases
Measure: Number of participants with Increase in liver transaminases (AST and ALT) > 3 times the upper limit of normal Time: day 90Description: Number of participants with Increase in liver transaminases
Measure: Number of participants with Increase in liver transaminases (AST and ALT) > 3 times the upper limit of normal Time: day 180Description: Number of participants with Thrombotic events: venous or arterial thrombosis
Measure: Number of participants with Thrombotic events Time: day 90Description: Number of participants with Thrombotic events: venous or arterial thrombosis
Measure: Number of participants with Thrombotic events Time: day 180Description: Number of participants with 10% weight loss
Measure: Number of participants with 10% weight loss over 90 days Time: day 90Description: Number of participants with 10% weight loss
Measure: Number of participants with 10% weight loss over 90 days Time: day 180Description: Number of participants with Nausea/emesis/diarrhea not responsive to anti-emetics and anti-motility agents
Measure: Number of participants with GI events Time: day 90Description: Number of participants with Nausea/emesis/diarrhea not responsive to anti-emetics and anti-motility agents
Measure: Number of participants with GI events Time: day 180Project is designed as a comprehensive population-based epidemiological study in Upper-Silesian Conurbation (Poland) aiming at: 1. analysis of available data on incidence and mortality due to COVID-19 and 2. estimation of the occurrence of viral infection SARS-CoV-2 as revealed by the results of serological test (ELISA: IgM, IgG), with assessment of risk factors. The project's objectives are: to assess incidence and mortality due COVID-19 according to sex, age and coexisting diseases; to determine the level of potential "underdiagnosis" of the magnitude of COVID-19 mortality using vital statistics data for Upper-Silesian Conurbation; to assess the prevalence of SARS-CoV-2 based on the level of seropositivity in Upper-Silesian Conurbation; to identify host-related and environmental risk factors if the infection. Analysis of existing data will include monthly records on incidence and mortality over the period 01.01.2020-31.12.2020 and comparison of the findings with the monthly records of 2018 and 2019, for the same population. Cross-sectional epidemiological study will be located in three towne (Katowice, Sosnowiec, Gliwice). In each town a representative age-stratified sample of 2000 subjects will undergo questionnaire assessment and serological examination performed by serological test. The project corresponds with analogous population-based studies on COVID-19 in a number of countries and responds to the WHO recommendation in that field.
Description: Estimation of real prevalence of elevated IgM and IgG COVID antibodies in general population will allow to estimate real number of current and past COVID infection in the population.
Measure: Estimation of prevalence of specific anti-SARS-CoV-2 IgM and IgG antibodies in general population. Time: 8 monthsDescription: Prevalence of asymptomatic cases into seropositive population
Measure: Frequency of asymptomatic course of COVID in individuals with anti-SARS-CoV2 antibodies Time: 8 monthsSome COVID-19 survivors may have respiratory and mental health sequelae, especially those who required hospitalization. The investigators hypothesize that the participation of a rehabilitation program composite by home-based respiratory physiotherapy and telephone-based psychological support will improve respiratory function, quality of life, and psychological status in severe COVID-19 patients.
Description: Distance walked during 6-minutes (meters)
Measure: Six minute walk distance Time: Change from baseline measure at hospital discharge to week 6 and 12Description: The SGRQ scores from 0 (no impairment of quality of life by respiratory diseases/symptoms) to 100 (highest impairment of quality of life by respiratory diseases/symptoms)
Measure: Impact on overall health by respiratory diseases assessed by the score of the St. George's respiratory questionnaire (SGRQ) Time: Change from baseline measure at hospital discharge to week 6 and 12Description: The Patient Health Questionnaire-9 (PHQ-9) consists of nine items covering the Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) criteria for major depression scored on a four-point 0 (not at all) to 3 (almost every day) scale, with total scores ranging from 0 to 27. A greater score means worse depressive symptoms.
Measure: Depressive symptomatology assessed by the Patient Health Questionnaire (PHQ-9) Time: Change from baseline measure at hospital discharge to week 6 and 12Description: The Generalized Anxiety Disorder-7 (GAD-7) consists of seven items covering the DSM-IV criteria for GAD scored on a four-point 0 (not at all) to 3 (almost every day) scale, with total scores ranging from 0 to 21. A higher score means worse anxiety symptoms.
Measure: Anxious symptoms assessed by the Generalized Anxiety Disorder (GAD-7) questionnaire Time: Change from baseline measure at hospital discharge to week 6 and 12Description: The SF-36 questionnaire consists of 36 items, which are used to calculate eight subscales: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). The first four scores can be summed to create the physical composite score (PCS), while the last four can be summed to create the mental composite score (MCS). Scores for the SF-36 scales range between 0 and 100, with higher scores indicating a better health-related quality of life
Measure: Quality of life assessed by the Short Form Health Survey (SF-36) questionnaire Time: Change from baseline measure at hospital discharge to week 6 and 12Description: EQ-5D is a standardized tool for the assessment of quality of life in 5 different dimensions (Mobility, Self-Care, Usual Activities, Pain/Discomfort, Anxiety/Depression). Possible scores range from 1 (No problem) to 3 (Extreme problems) and each dimension are evaluated individually.
Measure: Quality of life assessed by the Health-Related Quality of Life (EQ-5D) questionnaire Time: Change from baseline measure at hospital discharge to week 6 and 12Description: Measured in milliliters by dynamic spirometry
Measure: Forced expiratory volume in the first second Time: Change from baseline measure at hospital discharge to week 6 and 12Description: Measured in milliliters by dynamic spirometry
Measure: Forced Vital Capacity Time: Change from baseline measure at hospital discharge to week 6 and 12Description: IES-R consists of 21 items covering the DSM-IV criteria for PTSD. Score varying from 0 (no risk of post traumatic stress) to 88 (highest risk of post traumatic stress).
Measure: Post-traumatic stress disorder symptomatology assessed by the Impact of Event Scale Revised (IES-R) questionnaire. Time: Change from baseline measure at hospital discharge to week 6 and 12This study is a randomized, double-blind, parallel arm study to evaluate the safety and efficacy of LYT-100 compared to placebo in adults with post-acute COVID-19 respiratory complications
Description: The 6MWT is a validated endpoint commonly used in clinical trial research
Measure: Change in distance walked on the six-minute walk test (6MWT) Time: Baseline to Day 91Description: The mBDS is an assessment tool that analyzes breathlessness under exertion
Measure: Change in Modified Borg Dyspnoea Scale (mBDS) score Time: Baseline to Day 91Description: The SF-36 (v2) is a self-administered questionnaire containing 36 items that measures functional status, well-being and overall evaluation of health in 8 domains
Measure: Quality of Life assessment as collected using the SF-36 Time: Baseline to Day 91The outbreak of the novel coronavirus SARS-CoV-2 caused a health emergency of international proportions when it was declared by the World Health Organization (WHO) in January 2020. Since then, the virus has spread internationally and the WHO has classified the outbreak as a pandemic. In the context of the increasing reporting of this pandemic and the increasing governmental measures to limit or slow down the spread of SARS-CoV-2 by all means, there is so far little scientific evidence for the effects of a healthy lifestyle on the disease. The aim of this study is to compare the potential of different, possibly protective lifestyles using the example of the COVID-19 pandemic. We will conduct an online survey with 3.000 participants using mobile website technology.
Description: The scale ranges from 0 to 100, where 0 is the lowest level of well-being / lowest quality of life and 100 is the highest level of well-being / highest quality of life.
Measure: WHO-5 Well-Being Index Time: Assessed when filling out the questionnaire (Baseline)Description: The NAS ranges from 0 to 10, where 0 is the lowest level of stress and 10 is the highest level of stress.
Measure: Numeric analog scale (NAS) stress Time: Assessed retrospectively (last 6 months) with self-designed questionDescription: The NAS ranges from 0 to 10, where 0 is the lowest level of anxiety and 10 is the highest level of anxiety.
Measure: Numeric analog scale (NAS) anxiety Time: Assessed retrospectively (last 6 months) with self-designed questionDescription: The NAS ranges from 0 to 10, where 0 is the lowest level of anxiety and 10 is the highest level of anxiety.
Measure: Numeric analog scale (NAS) depression Time: Assessed retrospectively (last 6 months) with self-designed questionDescription: The scale ranges from 0 to 100, where 0 is the lowest level of self-efficacy and 100 is the highest level of self-efficacy.
Measure: Self-efficacy Time: Assessed when filling out the questionnaire (Baseline)This study is a 4-arm, multicenter, randomized, partly double- blind, controlled trial to evaluate the safety and efficacy of convalescent serum (CP) or camostat mesylate with control or placebo in adult patients diagnosed with SARS-CoV-2 and high risk for moderate/severe COVID-19. The working hypothesis to be tested in the RES-Q-HR study is that the early use of convalescent plasma (CP) or camostat mesylate (Foipan®) reduces the likelihood of disease progression to modified WHO stages 4b-8 in SARS-CoV-2 positive adult patients at high risk of moderate or severe COVID-19 progression. The primary endpoint of the study is the cumulative number of individuals who progressed to or beyond category 4b on the modified WHO (World Health Organization) COVID-19 ordinal scale within 28 days after randomization.
Description: The primary endpoint of the study is the number of individuals whose clinical status is on the COVID-19 modified WHO ordinal scale ≥ 4b up to and including day 28
Measure: WHO ordinal Covid-19 scale up to day 28 Time: up to and including day 28Description: Cumulative number of persons in the respective treatment arms versus SoC/placebo in WHO categories 4b-8
Measure: Cumulative number WHO categories 4b-8 Time: day 8, day 14, day 56 and day 90Description: Cumulative number of persons in the respective treatment arms versus SoC/placebo in WHO categories 3-4a
Measure: Cumulative number WHO categories 3-4a Time: day 8, day 14, day 28, day 56 and day 90Description: Cumulative number of participants not hospitalized at day 90
Measure: Not hospitalized Time: at day 90Description: All-cause mortality at day 90
Measure: All-cause mortality Time: at day 90Description: Number of patient with SARS-CoV-2 reinfection up to day 90
Measure: Reinfection Time: up to day 90Description: Number of patient with secondary sclerosis cholangitis at day 90
Measure: Secondary sclerosing cholangitis (SSC) Time: at day 90Description: Number of patient with COVID-19 associated chronic pulmonary disease
Measure: chronic pulmonary disease as sequelae from COVID-19 Time: at day 90Description: The proportion of patients with remdesivir therapy
Measure: patients with remdesivir treatment Time: up to day 90Description: The clinical status on the WHO COVID-19 ordinal scale of at the start of remdesivir treatment WHO ordinal scale ranges from 0 to 8; whereas 0 = no COVID-19 infection and 8 = death
Measure: COVID-19 WHO status of patients at start of remdesivir treatment Time: up to day 90Description: The proportion of patients on dexamethasone therapy
Measure: patients with dexamethasone treatment Time: up to day 90Description: The clinical status on the WHO COVID-19 ordinal scale of at the start of dexamethasone treatment WHO ordinal scale ranges from 0 to 8; whereas 0 = no COVID-19 infection and 8 = death
Measure: COVID-19 WHO status of patients at start of dexamethasone treatment Time: up to day 90Description: Time to resolution of COVID-19 related symptoms (e.g. fever)
Measure: resolution of COVID-19 symptoms Time: until day of resolution up to day 90Description: Time to first negative SARS-CoV-2-PCR (polymerase chain reaction)
Measure: negative SARS-CoV-2-PCR test Time: until day of first negative test up to day 90Description: Duration of oxygen therapy (in days)
Measure: Oxygen therapy Time: number of days with oxygen therapy up to day 90Description: Frequency of occurrence of COVID-19 pneumonia
Measure: COVID-19 pneumonia Time: up to day 90Description: Percentage of participants in each group with need for mechanical ventilation
Measure: Percentage of participants requiring mechanical ventilation Time: up to day 90Description: Number of ventilation days per participant up to day 90
Measure: Number of ventilation days per participant up to day 90 Time: up to day 90Description: Duration of hospital stay (in days), duration in intensive care/intermediate care (IMC) (in days)
Measure: hospital stay and intensive care Time: up to day 90Description: All-cause mortality at day 28
Measure: Mortality Time: at day 28Description: Cumulative incidence of Serious Adverse Events (SAE) per group within 90 days follow up
Measure: SAEs Time: up to day 90Description: Cumulative incidence of grade 3/4 Adverse Events (AE) per group
Measure: Grade 3/4 AEs Time: up to day 90Description: SARS-CoV-2 antibody concentrations (IgA in g/l) in serum on day 8, day 14, day 90
Measure: SARS-CoV-2 antibody IgA concentrations Time: on day 8, day 14, day 90Description: SARS-CoV-2 antibody concentrations (IgG in g/l) in serum on day 8, day 14, day 90
Measure: SARS-CoV-2 antibody IgG concentrations Time: on day 8, day 14, day 90Description: SARS-CoV-2 neutralizing antibody titers in serum on day 8, day 14, day 90
Measure: SARS-CoV-2 neutralizing antibody titers Time: on day 8, day 14, day 90Description: Number of screening failures due to the lack of a suitable plasma preparation
Measure: Plasma treatment screening failures Time: up to day 8 (End of treatment)Alphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on January 01, 2021.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
Drug Reports MeSH Reports HPO Reports