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Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
Name (Synonyms) | Correlation | |
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drug3441 | Tofacitinib Wiki | 0.31 |
drug2189 | Nintedanib Wiki | 0.27 |
drug3220 | Standard treatment according to the Clinical protocols Wiki | 0.27 |
Name (Synonyms) | Correlation | |
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drug2037 | Microcannula Harvest Adipose Derived tissue stromal vascular fraction (tSVF) Wiki | 0.27 |
drug1597 | IV Deployment Of cSVF In Sterile Normal Saline IV Solution Wiki | 0.27 |
drug725 | Centricyte 1000 Wiki | 0.27 |
drug789 | Clinical, laboratory and imaging characteristics of pneumonia Wiki | 0.27 |
drug196 | Allogenic pooled olfactory mucosa-derived mesenchymal stem cells Wiki | 0.27 |
drug2699 | Pulmonary ultrasound Wiki | 0.27 |
drug3024 | Scanning Chest X-rays and performing AI algorithms on images Wiki | 0.27 |
drug2697 | Pulmonary function tests Wiki | 0.27 |
drug3770 | bovhyaluronidase azoxymer Wiki | 0.27 |
drug1817 | Liberase Enzyme (Roche) Wiki | 0.27 |
drug3857 | high-titer anti-Sars-CoV-2 plasma Wiki | 0.27 |
drug2961 | SELF-BREATHE Wiki | 0.27 |
drug579 | COVI-AMG Wiki | 0.27 |
drug1618 | Imaging Wiki | 0.27 |
drug3233 | Sterile Normal Saline for Intravenous Use Wiki | 0.27 |
drug4099 | survey Wiki | 0.19 |
drug3991 | oxygen therapy Wiki | 0.19 |
drug385 | BNT162b2 Wiki | 0.13 |
drug491 | Blood sampling Wiki | 0.09 |
drug899 | Convalescent plasma Wiki | 0.06 |
drug2490 | Placebo Wiki | 0.04 |
drug1507 | Hydroxychloroquine Wiki | 0.03 |
Name (Synonyms) | Correlation | |
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D008171 | Lung Diseases, NIH | 0.33 |
D001987 | Bronchiectasis NIH | 0.31 |
D011658 | Pulmonary Fibrosis NIH | 0.28 |
Name (Synonyms) | Correlation | |
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D001469 | Barotrauma NIH | 0.27 |
D011649 | Pulmonary Alveolar Proteinosis NIH | 0.27 |
D004646 | Emphysema NIH | 0.27 |
D017093 | Liver Failure NIH | 0.27 |
D054990 | Idiopathic Pulmonary Fibrosis NIH | 0.19 |
D005355 | Fibrosis NIH | 0.15 |
D003550 | Cystic Fibrosis NIH | 0.15 |
D000755 | Anemia, Sickle Cell NIH | 0.13 |
D011014 | Pneumonia NIH | 0.13 |
D011024 | Pneumonia, Viral NIH | 0.12 |
D053717 | Pneumonia, Ventilator-Associated NIH | 0.09 |
D007251 | Influenza, Human NIH | 0.08 |
D004417 | Dyspnea NIH | 0.08 |
D012120 | Respiration Disorders NIH | 0.06 |
D012140 | Respiratory Tract Diseases NIH | 0.05 |
D003141 | Communicable Diseases NIH | 0.02 |
D007239 | Infection NIH | 0.01 |
D045169 | Severe Acute Respiratory Syndrome NIH | 0.01 |
D018352 | Coronavirus Infections NIH | 0.01 |
Name (Synonyms) | Correlation | |
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HP:0006515 | Interstitial pneumonitis HPO | 1.00 |
HP:0002088 | Abnormal lung morphology HPO | 0.35 |
HP:0002110 | Bronchiectasis HPO | 0.31 |
Name (Synonyms) | Correlation | |
---|---|---|
HP:0002206 | Pulmonary fibrosis HPO | 0.28 |
HP:0006517 | Intraalveolar phospholipid accumulation HPO | 0.27 |
HP:0001399 | Hepatic failure HPO | 0.27 |
HP:0002090 | Pneumonia HPO | 0.13 |
HP:0002098 | Respiratory distress HPO | 0.08 |
Navigate: Correlations HPO
There are 14 clinical trials
This project aims to use artificial intelligence (image discrimination) algorithms, specifically convolutional neural networks (CNNs) for scanning chest radiographs in the emergency department (triage) in patients with suspected respiratory symptoms (fever, cough, myalgia) of coronavirus infection COVID 19. The objective is to create and validate a software solution that discriminates on the basis of the chest x-ray between Covid-19 pneumonitis and influenza
Description: Number of participants with pneumonitis on Chest X-Ray and COVID 19 positive
Measure: COVID-19 positive X-Rays Time: 6 monthsDescription: Number of participants with pneumonitis on Chest X-Ray and COVID 19 negative
Measure: COVID-19 negative X-Rays Time: 6 monthsCOVID-19 Viral Global Pandemic resulting in post-infection pulmonary damage, including Fibrotic Lung Disease due to inflammatory and reactive protein secretions damaging pulmonary alveolar structure and functionality. A short review includes: - Early December, 2019 - A pneumonia of unknown cause was detected in Wuhan, China, and was reported to the World Health Organization (WHO) Country Office. - January 30th, 2020 - The outbreak was declared a Public Health Emergency of International Concern. - February 7th, 2020 - 34-year-old Ophthalmologist who first identified a SARS-like coronavirus) dies from the same virus. - February 11th, 2020 - WHO announces a name for the new coronavirus disease: COVID-19. - February 19th, 2020 - The U.S. has its first outbreak in a Seattle nursing home which were complicated with loss of lives.. - March 11th, 2020 - WHO declares the virus a pandemic and in less than three months, from the time when this virus was first detected, the virus has spread across the entire planet with cases identified in every country including Greenland. - March 21st, 2020 - Emerging Infectious Disease estimates the risk for death in Wuhan reached values as high as 12% in the epicenter of the epidemic and ≈1% in other, more mildly affected areas. The elevated death risk estimates are probably associated with a breakdown of the healthcare system, indicating that enhanced public health interventions, including social distancing and movement restrictions, should be implemented to bring the COVID-19 epidemic under control." March 21st 2020 -Much of the United States is currently under some form of self- or mandatory quarantine as testing abilities ramp up.. March 24th, 2020 - Hot spots are evolving and identified, particularly in the areas of New York-New Jersey, Washington, and California. Immediate attention is turned to testing, diagnosis, epidemiological containment, clinical trials for drug testing started, and work on a long-term vaccine started. The recovering patients are presenting with mild to severe lung impairment as a result of the viral attack on the alveolar and lung tissues. Clinically significant impairment of pulmonary function appears to be a permanent finding as a direct result of the interstitial lung damage and inflammatory changes that accompanied. This Phase 0, first-in-kind for humans, is use of autologous, cellular stromal vascular fraction (cSVF) deployed intravenously to examine the anti-inflammatory and structural potential to improve the residual, permanent damaged alveolar tissues of the lungs.
Description: Reporting of Adverse Events or Severe Adverse Events Assessed by CTCAE v4.0
Measure: Incidence of Treatment-Emergent Adverse Events Time: 1 monthDescription: High Resolution Computerized Tomography of Lung (HRCT Lung) for Fluidda Analysis comparative at baseline and 3 and 6 months post-treatment comparative analytics
Measure: Pulmonary Function Analysis Time: baseline, 3 Month, 6 monthsDescription: Finger Pulse Oximetry taken before and after 6 minute walk on level ground, compare desaturation tendency
Measure: Digital Oximetry Time: 3 months, 6 monthsImmune-mediated lung injury plays a pivotal role in severe interstitial pnemumonia related to SARS-CoV2 infection. Tofacitinib, a JAK1/3-Inhibitor, could mitigate alveolar inflammation by blocking IL-6 signal. The aim of this prospective single cohort open study is to test the hypotesis that early administration of tofacitinib in patients with symptomatic pneumonia could reduce pulmonary flogosis, preventing function deterioration and the need of mechanical ventilation and/or admission in intensive care units.
Description: Rate of patients needing mechanical ventilation to maintain PaO2/FIO2>150 or, if PaO2 data not available, to maintain SO2>94% with FiO2 0,5.
Measure: need of mechanical ventilation Time: day 14Description: Rate of patients needing admission to the intensive care unit for oro-tracheal intubation and/or evidence of Multiple Organ Disfunction
Measure: need of admission in intensive care unit Time: day 14Description: rate of patients dead
Measure: death Time: day 28Description: rate and type of adverse events
Measure: rate of adverse events Time: day 28Currently there are no proven treatment option for COVID-19. Human convalescent plasma is an option for COVID-19 treatment and could be available from people who have recovered and can donate plasma.
Description: reduction in oxygen and ventilation support
Measure: reduction in oxygen and ventilation support Time: through study completion, an average of 4 weeksThe recent pandemic due to the SARS-CoV2 results in a pulmonary infection in major symptomatic patients. Because of the large number of patients and the risk of acute respiratory distress syndrome (which seems to occur in almost 5% of patients), there is a real challenge to improve physician ability to screen between patients those who will require specific surveillance and those who can be sent back home. The recent French official recommendation of the French radiology society prescribe that chest X-ray do not have any place in the COVID-19+ management whereas the WHO stipulate that ultrasound machines may be useful for these patients [1-2]. Moreover, scattered recent publications tend to stress the interest of quick ultrasound imaging for COVID-19 suspected patients for screening purpose [2-5]. The aim of this observational historico-prospective study is to assess the risk of severe clinical outcomes (admission in continuous care unit (USC), invasive respiratory assistance, death) in patients suspected or diagnosed COVID-19+ as a function of initial pulmonary ultrasound abnormalities. These clinical outcomes are assessed through phone calls at D5, D15, M1. The secondary objectives are: - Assessing the concordance between the severity of pulmonary lesions as detected by pulmonary ultrasound devices and the ones detected by CT-scanner, for patients who will undergo these two examinations. - Assessing the compared performances in detecting ultrasound pulmonary lesions for patients suspected or diagnosed COVID-19+, between an experimented operator and a newly trained operator.
Description: Association of pulmonary lesions on ultrasound on D0 classified according to three stages of severity There are few B lines at the lung bases Bi-lateralization of B lines, numerous diffuse and / or curtain sign Presence of signs of pulmonary consolidation, hepatization of the lung and air bronchogram)
Measure: Association of pulmonary lesions on ultrasound on D0 classified according to three stages of severity Time: at day0Treatment of patients with Covid-19 associated pneumonia using intravenous injection of allogenic pooled olfactory mucosa-derived mesenchymal stem cells
Description: Number of patients cured, assessed by PCR in addition to chest CT scan
Measure: Number of cured patients Time: 3 weeksDescription: MSC infusion related adverse events assessed by blood count, liver and function tests
Measure: Number of patients with treatment-related adverse events Time: 3 weeksMultifocal interstitial pneumonia represents the most common cause of admission in intensive care units and death in SARS-CoV2 infections. In our Hospital, similarly to what reported in literature, up to 25% of admitted patients with pneumonitis requires mechanical ventilation or oro-tracheal intubation within 5-10 days. No established treatment is available for this condition. Preliminary evidence is accumulating about the efficacy of an aggressive treatment of the corona virus-induced inflammation and, in particular, investigators believe that blocking JAK1 is clinically rewarding in down-regulating IL-6 driven inflammation in patients with corona-virus infection. Thus, investigators designed a randomized controlled trial to test the hypothesis that adding Tofacitinib to the standard treatment in the early phase of COVID related pneumonitis could prevent the development of severe respiratory failure needing mechanical ventilation.
Description: Rate of patients needing mechanical ventilation to maintain PaO2/FIO2>150
Measure: Prevention of severe Respiratory Failure requiring mechanical ventilation Time: 14 daysDescription: Rate of patients needing admission to the intensive care unit
Measure: Prevention of need of ICU admission Time: 28 daysDescription: Rate of patients who die due to COVID-19 related conditions
Measure: Prevention of COVID-19 related Deaths Time: 28 daysDescription: Role of some clinical and laboratory factors in predicting outcome (Age, sex, smoking status, Body Mass Index (BMI), Comorbidities (Diabetes, number of comorbidities), Respiratory Failure at admission defined as PaO2/FiO2<300, Extension of Ct-scan involvement, basal level of serum IL-6, vW-Factor, Thrombomodulin, KL-6, sACE2 and SP-D )
Measure: Identification of predictors of outcome Time: 14 daysDescription: Rate of severe drug-related adverse events
Measure: Incidence of Treatment-Emergent Adverse Events Time: 28 daysCOVID-19, the infectious disease caused by the novel coronavirus SARS-CoV-2, currently poses a global economic, social, political and medical challenge. The virus originated in December 2019 in Wuhan, China, and has spread rapidly around the world. Currently, European countries, including Austria, are severely affected.The most common computed tomographic changes in acute lung injury include bilateral and subpleural milk glass opacity, consolidation in lower lobes, or both. In the intermediate phase of the infection (4-14 days after the onset of symptoms) a so-called "crazy paving" may occur. The most prominent radiological changes occur around day 10, followed by gradual resolution, which begins two weeks after the onset of symptoms. Given the phylogenetic relationship between SARS-CoV-1 and SARS-CoV-2, the similar clinical course in severe cases and overlapping CT patterns in the acute setting, persistent radiological and pulmonary functional changes in survivors are conceivable. It is also conceivable that a proportion of survivors will develop progressive ILD, either due to viral or ventilator-induced alveolar damage, or both. Here, the investigators intend to investigate COVID-19 survivors through clinical examinations, functional lung examinations, HR-CT scans, and by determining the "immunofibrotic" pattern in peripheral mononuclear cells (PBMCs) 1, 3, and 6 months after discharge.
Description: Define the frequency of ILD and pulmonary vascular disease in SARS-CoV-2 infected patients with a severe/prolonged Course (inhospital stay, either on the normal ward or ICU), with and without oxygen supplementation, non-invasive or invasive ventilation) at 1 month after discharge or diagnosis of COVID-19 disease by the use of HR-CT.
Measure: Pattern of pulmonary abnormalities in SARS-CoV2 infected patients after 1 month Time: 1 monthDescription: Define the frequency of ILD and pulmonary vascular disease in SARS-CoV-2 infected patients with a severe/prolonged Course (inhospital stay, either on the normal ward or ICU), with and without oxygen supplementation, non-invasive or invasive ventilation) at 3 months after discharge or diagnosis of COVID-19 disease by the use of HR-CT
Measure: Pattern of pulmonary abnormalities in SARS-CoV2 infected patients after 3 months Time: 3 monthsDescription: Define the frequency of ILD and pulmonary vascular disease in SARS-CoV-2 infected patients with a severe/prolonged Course (inhospital stay, either on the normal ward or ICU), with and without oxygen supplementation, non-invasive or invasive ventilation) at 6 months after discharge or diagnosis of COVID-19 disease by the use of HR-CT
Measure: Pattern of pulmonary abnormalities in SARS-CoV2 infected patients after 6 months Time: 6 monthsPneumonia is a recurrent element of COVID-19 infection, it is often associated with development of respiratory failure and patients frequently need various degrees of oxygen therapy up to non invasive ventilation (NIV-CPAP) and invasive mechanical ventilation (IMV). Main purpose of this study is to evaluate with non invasive clinical instruments (pletysmography, Diffusion lung capacity for carbon monoxide -DLCO-, six minute walking test and dyspnea scores) and radiological tools (chest X-ray and chest CT scan) the development of medium-to-long term pulmonary sequelae caused by SARS-CoV-2 pneumonia.
Description: Reduction below 80% of predicted values of DLCO
Measure: Reduction of Diffusion of Lung CO (DLCO, single breath technique) Time: T1 at 6 months from dischargeDescription: Reduction below 80% of predicted values of DLCO
Measure: Reduction of Diffusion of Lung CO (DLCO, single breath technique) Time: T2 at 12 months from dischargeDescription: reduction in maximum distance walked
Measure: Alterations in 6 minute walking test (6MWT) Time: T1 at 6 months from dischargeDescription: reduction in maximum distance walked
Measure: Alterations in 6 minute walking test (6MWT) Time: T2 at 12 months from dischargeDescription: reduction in oxygen saturation nadir
Measure: Alterations in 6 minute walking test (6MWT) Time: T1 at 6 months from dischargeDescription: reduction in oxygen saturation nadir
Measure: Alterations in 6 minute walking test (6MWT) Time: T2 at 12 months from dischargeDescription: reduction of Forced Vital Capacity (FVC, %)
Measure: Alterations of pletismography Time: T1 at 6 months from dischargeDescription: reduction of Forced Vital Capacity (FVC, %)
Measure: Alterations of pletismography Time: T2 at 12 months from dischargeDescription: reduction of Forced Vital Capacity (FVC, L)
Measure: Alterations of pletismography Time: T1 at 6 months from dischargeDescription: reduction of Forced Vital Capacity (FVC, L)
Measure: Alterations of pletismography Time: T2 at 12 months from dischargeDescription: reduction of Vital Capacity (VC, %)
Measure: Alterations of pletismography Time: T1 at 6 months from dischargeDescription: reduction of Vital Capacity (VC, %)
Measure: Alterations of pletismography Time: T2 at 12 months from dischargeDescription: reduction of Vital Capacity (VC, L)
Measure: Alterations of pletismography Time: T1 at 6 months from dischargeDescription: reduction of Vital Capacity (VC, L)
Measure: Alterations of pletismography Time: T2 at 12 months from dischargeDescription: reduction of Forced Expiratory Volume in the 1st second (FEV1, L)
Measure: Alterations of pletismography Time: T1 at 6 months from dischargeDescription: reduction of Forced Expiratory Volume in the 1st second (FEV1, %)
Measure: Alterations of pletismography Time: T1 at 6 months from dischargeDescription: reduction of Forced Expiratory Volume in the 1st second (FEV1, L)
Measure: Alterations of pletismography Time: T2 at 12 months from dischargeDescription: reduction of Forced Expiratory Volume in the 1st second (FEV1, L%)
Measure: Alterations of pletismography Time: T2 at 12 months from dischargeDescription: reduction of Total Lung Capacity (TLC, L)
Measure: Alterations of pletismography Time: T1 at 6 months from dischargeDescription: reduction of Total Lung Capacity (TLC, %)
Measure: Alterations of pletismography Time: T1 at 6 months from dischargeDescription: reduction of Total Lung Capacity (TLC, L)
Measure: Alterations of pletismography Time: T2 at 12 months from dischargeDescription: reduction of Total Lung Capacity (TLC, %)
Measure: Alterations of pletismography Time: T2 at 12 months from dischargeDescription: alterations of Residual Volume (RV,%)
Measure: Alterations of pletismography Time: T1 at 6 months from dischargeDescription: alterations of Residual Volume (RV, L)
Measure: Alterations of pletismography Time: T1 at 6 months from dischargeDescription: alterations of Residual Volume (RV, L)
Measure: Alterations of pletismography Time: T2 at 12 months from dischargeDescription: alterations of Residual Volume (RV, %)
Measure: Alterations of pletismography Time: T2 at 12 months from dischargeDescription: increase of Specific Airway Resistance (sRAW) (absolute value)
Measure: Alterations of pletismography Time: T1 at 6 months from dischargeDescription: increase of Specific Airway Resistance (sRAW) (%)
Measure: Alterations of pletismography Time: T1 at 6 months from dischargeDescription: increase of Specific Airway Resistance (sRAW) (absolute value)
Measure: Alterations of pletismography Time: T2 at 12 months from dischargeDescription: increase of Specific Airway Resistance (sRAW) (%)
Measure: Alterations of pletismography Time: T2 at 12 months from dischargeDescription: alterations of Motley Index (VR/CPT)
Measure: Alterations of pletismography Time: T1 at 6 months from dischargeDescription: alterations of Motley Index (VR/CPT)
Measure: Alterations of pletismography Time: T2 at 12 months from dischargeDescription: alterations of Tiffeneau Index (IT)
Measure: Alterations of pletismography Time: T1 at 6 months from dischargeDescription: alterations of Tiffeneau Index (IT)
Measure: Alterations of pletismography Time: T2 at 12 months from dischargeDescription: reduction of PaO2 mmHg
Measure: Alterations of Arterial Blood Gas Analysis Time: T1 at 6 months from dischargeDescription: reduction of PaO2 mmHg
Measure: Alterations of Arterial Blood Gas Analysis Time: T2 at 12 months from dischargeDescription: alteration of PaCO2 mmHg
Measure: Alterations of Arterial Blood Gas Analysis Time: T1 at 6 months from dischargeDescription: alteration of PaCO2 mmHg
Measure: Alterations of Arterial Blood Gas Analysis Time: T2 at 12 months from dischargeDescription: Modified Medical Research Council - mMRC > 0 (minimum 0, maximum 4; higher score means worse outcome)
Measure: Abnormal Dyspnea Score Time: T1 at 6 months from dischargeDescription: Modified Medical Research Council - mMRC > 0(minimum 0, maximum 4; higher score means worse outcome)
Measure: Abnormal Dyspnea Score Time: T2 at 12 months from dischargeDescription: Presence and extension of abnormal pulmonary lung sounds at auscultation
Measure: Presence and extension of abnormal pulmonary lung sounds at auscultation Time: T1 at 6 months from dischargeDescription: Presence and extension of abnormal pulmonary lung sounds at auscultation
Measure: Presence and extension of abnormal pulmonary lung sounds at auscultation Time: T2 at 12 months from dischargeDescription: Presence and extension of radiological alterations at chest X-ray
Measure: Presence and extension of radiological alterations at chest X-ray Time: T1 at 6 months from dischargeDescription: Presence and extension of radiological alterations at chest CT scan
Measure: Presence and extension of radiological alterations at chest CT scan Time: T2 at 12 months from dischargeThe investigating group aims at performing an observational, prospective study that involves the evaluation of circulating biomarkers predictive of clinical evolution in patients suffering from COVID-19 disease. In particular, the aim will be to verify whether there are transcripts or cytokines / chemokines in peripheral blood, modulated differently in patients with COVID-19, distinguished on the basis of the evolution towards more severe clinical pictures that require patient intubation or that show signs of cardiovascular damage. The study will be based on the transcriptional analysis of the entire genome and serum protein to evaluate the expression of a broad spectrum of cytokines and chemokines. Genome analysis will allow the genotype to be correlated to the identified gene expression profiles.
Description: Identify circulating transcripts (coding and non-coding for proteins) or cytokines and chemokines which, alone or in combination (COVID19_signature), are predictive of adverse events (death, endotracheal intubation) and the prognostic capacity of COVID19_signature in the prediction of adverse events in additional to the use of standard clinical parameters
Measure: Circulating markers for COVID-19 signature Time: From ICU/ward admission for 8 weeks follow/upDescription: Evaluate the association of COVID19_signature with adverse cardiovascular events. Adverse cardiovascular events are defined: death from cardiovascular causes, acute coronary syndrome, troponin T levels greater than the ninety-ninth percentile of the upper reference limit, stroke, cardiac arrhythmias, development of heart failure, venous thromboembolism
Measure: COVID-19 signature and adverse cardiovascular events Time: From ICU/ward admission for 8 weeks follow/upDescription: Evaluate, in a subset of 20 patients, the characteristics of the coagulation pattern with specific tests for thrombin generation and fibrinolysis.
Measure: COVID-19 related coagulation pattern Time: From ICU/ward admission for 8 weeks follow/upIn the late 2019 a new Coronavirus was identified as the cause of a group of atypical interstitial pneumonia cases in Wuhan, a city in the Chinese province of Hubei. In February 2020, the World Health Organization designated COVID-19 disease, which stands for Coronavirus 2019 disease. Following the progressive spread of the infection in other countries of the world, WHO declared the Pandemic on 11 March 2020. Italy was the first European country involved in the spread of the infection and among those with the highest number of victims. The Coronavirus responsible for COVID-19 has, as its main target organ, the respiratory system, being able to determine a serious acute respiratory syndrome similar to that of the cases found during the SARS epidemic of 2003: hence the name of the virus as SARS-CoV-2. The diagnosis of SARS-COV-2 infection is made by direct detection by PCR of viral RNA on different biological materials from patients with suspicious symptoms, and the first level diagnostic test is generally the nasopharyngeal swab. However, even if the specificity of the nasopharyngeal swab is high, its sensitivity can be affected by technical causes (sampling mode), as well as by intrinsic factors related to the method. The purpose of the study is to identify the clinical, laboratory and imaging characteristic which are similar or which can differentiate the hospitalized patients affected by COVID-19 pneumonia (with positive PCR on naso-pharyngeal swab) and patients with pneumonia with negative PCR for COVID-19. To do this, the investigators will compare the clinical, laboratory and imaging characteristics between interstitial pneumonia secondary to SARS-COV-2 infection, confirmed by molecular biology investigations (viral RNA research by PCR on nasopharyngeal swab) and cases of interstitial pneumonia negative to the nasopharyngeal swab.
Description: Accuracy of severity of respiratory insufficiency - evaluated as need of three step "nasal oxygen, oxygen mask, invasive ventilation" - in differentiate COVID-19 infection, classified according to the results of PCR assay for COVID-19 on naso-pharyngeal swab as "COVID-19 patients" and "COVID-19 negative controls"
Measure: Evaluation of the clinical characteristics of patients with clinical presentation suggestive of COVID-19 infection, classified according to the results of PCR assay as "COVID-19 patients" and "COVID-19 negative controls". Time: 75 DaysDescription: Accuracy of the association of 3 haemato-chemical abnormalities (lymphopenia + increased serum transaminases + increased serum LDH) in differentiate COVID-19 infection, classified according to the results of PCR assay for COVID-19 on naso-pharyngeal swab as "COVID-19 patients" and "COVID-19 negative controls".
Measure: Evaluation of the laboratory characteristics of patients with clinical presentation suggestive of COVID-19 infection, classified according to the results of PCR assay as "COVID-19 patients" and "COVID-19 negative controls". Time: 75 DaysDescription: Accuracy of thorax CT scan in differentiate COVID-19 infection, classified according to the results of PCR assay for COVID-19 on naso-pharyngeal swab as "COVID-19 patients" and "COVID-19 negative controls".
Measure: Evaluation of the imaging characteristics of patients with clinical presentation suggestive of COVID-19 infection, classified according to the results of PCR assay as "COVID-19 patients" and "COVID-19 negative controls". Time: 75 DaysDescription: Evaluation of mortality in "COVID-19 patients" and "COVID-19 negative controls", hospitalized in the study period.
Measure: Evaluation of mortality of patients with clinical presentation suggestive of COVID-19 infection, classified according to the results of PCR assay as "COVID-19 patients" and "COVID-19 negative controls". Time: 75 DaysDescription: Evaluation of clinical severity in "COVID-19 patients" and "COVID-19 negative controls", hospitalized in the study period.
Measure: Evaluation of clinical severity of patients with clinical presentation suggestive of COVID-19 infection, classified according to the results of PCR assay as "COVID-19 patients" and "COVID-19 negative controls". Time: 75 DaysDescription: Evaluation of hospital stay length in "COVID-19 patients" and "COVID-19 negative controls", hospitalized in the study period.
Measure: Evaluation of hospital stay length of patients with clinical presentation suggestive of COVID-19 infection, classified according to the results of PCR assay as "COVID-19 patients" and "COVID-19 negative controls". Time: 75 DaysA feasibility RCT comprising two groups: 1. Intervention (SELF-BREATHE in addition to standard NHS care) 2. Control group (standard / currently available NHS care)
Description: The number of patients recruited into this study over a 12-month period
Measure: Feasibility: the number of patients recruited into this study over a 12-month period Time: 12 monthsThis 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 180A study is being conducted to evaluate the efficacy and safety of Longidaze for the prevention and treatment of post-inflammatory pulmonary fibrosis and interstitial lung disease following COVID-19.
Description: The severity of pulmonary tissue lesions with fibrosis and interstitial changes (%) according to high resolution computed tomography examination relative to the baseline value after 2.5 months in patients of the Longidaze® group compared with the dynamic observation group according to the results of a blinded central laboratory
Measure: The severity of lung tissue lesions with fibrosis and interstitial changes on day 75 Time: Day 0, Day 75Description: The severity of lung tissue damage by fibrosis and interstitial changes (%) according to high resolution computed tomography examination relative to the baseline value after 6 months in relation to the baseline values of the indicator in patients of the Longidaze® group in comparison with the the dynamic observation group (according to the results of a blinded central laboratory)
Measure: The severity of lung tissue damage by fibrosis and interstitial changes (%) on day 180 Time: Day 0, Day 180Description: The severity of lung tissue lesions with fibrosis and interstitial changes (%) according to high resolution computed tomography examination relative to the baseline value after 2.5 months and 6 months in patients of the Longidaze® group compared with the the dynamic observation group (according to the results of the local laboratory)
Measure: The severity of lung tissue lesions with fibrosis and interstitial changes (%) on day 75 and day 180 Time: Day 0, Day 75, Day 180Description: The severity of lesions of the lung tissue with fibrosis and interstitial changes and indicators: frosted glass, hydrothorax, consolidation (%) based on the high-resolution computed tomography images analyzed by the Botkin.AI program (artificial intelligence) and then verified by a specialist after 2.5 months and 6 months from the beginning of observation in relation to the baseline values of indicators in patients of the Longidaze® group in comparison with the dynamic observation group
Measure: The severity of lesions of the lung tissue with fibrosis and interstitial changes and indicators: frosted glass, hydrothorax, consolidation (%) images analyzed by the Botkin.AI program (artificial intelligence) Time: Day 75, Day 180Description: Change in forced vital capacity FVC (%) relative to the baseline value after 2.5 months and 6 months in patients of the Longidaze® group compared with the the dynamic observation group
Measure: Change in forced vital capacity (FVC) Time: Day 0, Day 75, Day 180Description: Change in the diffusion capacity of the lungs (%) relative to the baseline value after 2.5 months and 6 months in patients of the Longidaze® group compared with the the dynamic observation group
Measure: Change in the diffusion capacity of the lungs Time: Day 0, Day 75, Day 180Description: Change in the degree of dyspnea on the MMRC scale from baseline after 2.5 months and 6 months in patients of the Longidaze® group compared with the dynamic observation group. MMRC scale (Modified Medical Research Council scale) 0 - no - Dyspnea does not bother, except for very intense exercise - mild - Shortness of breath bothers with brisk walking or climbing a small elevation - moderate to severe - Shortness of breath results in slower walking compared to other people of the same age, or need to stop while walking at normal pace on a level surface - Severe - Shortness of breath makes you stop when walking about 100 m or after a few minutes of walking on a flat surface - very severe - Shortness of breath makes it impossible to leave the house or appears when dressing and undressing
Measure: Change in the degree of dyspnea on the MMRC scale Time: Day 0, Day 75, Day 180Description: Changes in SpO2 of capillary blood relative to the initial value after 2.5 months and 6 months in patients of the Longidaze® group compared with the dynamic observation group.
Measure: Changes in capillary blood oxygen saturation (SpO2) Time: Day 0, Day 75, Day 180Description: Changes in the covered footage in the 6-minute walk test after 2.5 months and 6 months in patients of the Longidaze® group compared with the dynamic observation group.
Measure: Changes in the covered footage in the 6-minute walk test Time: Day 0, Day 75, Day 180Description: Changes in capillary blood saturation (SpO2) after a 6-minute walk test after 2.5 months and 6 months in patients of the Longidaze® group compared with the dynamic observation group.
Measure: Changes in capillary blood saturation (SpO2) after a 6-minute walk test Time: Day 0, Day 75, Day 180Description: Change in the residual volume of the lungs after 2.5 months in patients of the Longidaze® group compared with the dynamic observation group.
Measure: Change in the residual volume of the lungs Time: Day 0, Day 75Description: Change in the total lung capacity after 2.5 months in patients of the Longidaze® group compared with the dynamic observation group.
Measure: Change in the total lung capacity Time: Day 0, Day 75Description: Change in inspiratory capacity after 2.5 months in patients of the Longidaze® group compared with dynamic observation group
Measure: Change in inspiratory capacity Time: Day 75Alphabetical 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